first african medicines regulatory authorities conference...

FIRST AFRICAN

MEDICINES REGULATORY

AUTHORITIES CONFERENCE

FINAL REPORT

First African Medicines Regulatory Authorities Conference

Final Report

WHO/AFRO/EDM/09.1

In collaboration withDepartment of Medicines Policy and Standards (PSM)

Department of Technical Cooperation for EssentialMedicines and Traditional Medicine (TCM)

Addis Ababa, Ethiopia31 October – 3 November 2005

AFRO Library Cataloguing-in-Publication Data

First African Medicines Regulatory Authorities Conference: Final Report

1. Legislation, Drug2. Drug Industry 3. Economics, Pharmaceutical4. Public Health5. Congresses as Topic6. Africa

ISBN : 978 929 023 1417 (NLM Classification: QV 33 )

© WHO Regional Office for Africa, 2009

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ABBREVIATIONS ................................................................................................................I

EXECUTIVE SUMMARY .......................................................................................................III

1. INTRODUCTION...........................................................................................................11.1 Background...........................................................................................................11.2 Participants ...........................................................................................................2

2. OPENING OF THE MEETING ........................................................................................22.1 Introduction to the conference .............................................................................22.2 Welcome address .................................................................................................42.3 Official Opening of the Conference ......................................................................42.4 Message from WHO/HQ .......................................................................................52.5 Administrative arrangements ................................................................................5

3. METHOD OF WORK .....................................................................................................6

4. MAIN TOPICS PRESENTED AND DISCUSSED AT PLENARY .........................................64.1 Medicines regulation in sub-Saharan Africa: an overview .......................................64.2 Country initiatives to promote effective medicines regulation .................................84.3 Medicines regulation development path: concept for discussion .........................134.4 Revamping medicines regulation to respond to public health priorities ...............144.5 Medicines regulation harmonization in Africa ......................................................154.6 Effective law enforcement and regulation of distribution .....................................224.7 Ethical practice, conflict of interest, code of conduct in medicines regulation .......224.8 Rapid alert system on quality of medicines .........................................................234.9 Counterfeit medicines: framework convention ...................................................234.10 Current topics ....................................................................................................24

5. DEVELOPMENT OF THE REGIONAL STRATEGIC PLAN ..............................................28

6. RECOMMENDATIONS ................................................................................................33

7. CLOSING CEREMONY .................................................................................................34

ANNEX: LIST OF PARTICIPANTS ........................................................................................35

CONTENTS

Page

ABBREVIATIONS

ADR Adverse Drug Reaction

AFDRAN African Drug Regulatory Authority Network

AIDS Acquired Immunodeficiency Syndrome

AMRAC African Medicines Regulatory Authorities Conference

ARFI Adverse Reactions Following Immunization

ARV Antiretroviral Medicines

AU African Union

CEAC Economic Community of Central Africa States

COMESA Common Market of Eastern and Southern Africa

DACA Drug Administration and Control Authority

DFID Department for International Development (of United Kingdom)

DRA Drug Regulatory Agency/Authority

DPM Directorate of Pharmaceutical Services

EAC East African Community

EU European Union

ECOWAS Economic Community of West African States

EDM Essential Drugs and Medicines Policy

EML Essential Medicines List

GCP Good Clinical Practices

GDP Good Distribution Practices

GMP Good Manufacturing Practices

GTN Global Training Network

ICDRA International Conference of Drug Regulatory Authorities

ICH International Conference on Harmonization of TechnicalRequirements for the Registration of Pharmaceuticals for Human Use

IEC Information, Education and Communication

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HIV Human Immunodeficiency Virus

MDG Millennium Development Goal

MOH Ministry of Health

MRA Medicines Regulatory Authority

NDA National Drug Authority

NDP National Drug Policy

NEPAD New Partnership for Africa's Development

NMRA National Medicines Regulatory Authority

NPO National Professional Officer

PMS Post Marketing Surveillance

PSM Medicines Policy and Standards (Department of WHO)

QC Quality Control (of Medicines)

QSM Quality and Safety of Medicines (Team of WHO/PSM)

RAS Rapid Alert System

RDU Rational Drug Use

SADC Southern African Development Community

TCM Technical Cooperation on Essential Drugs and Traditional Medicines (Department of WHO)

TRIPS Trade-Related Aspects of Intellectual Property Rights

UEMOA West African Monetary and Economic Union

WAHO West African Health Organisation

WCO WHO Country Office

WHO World Health Organization

WR WHO Country Representative

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EXECUTIVE SUMMARY

Currently, about 7% of the 46 sub-Saharan African countries have a moderately developed medicine regulatory capacity. Of the remaining, about 63% have minimal capacities whereas 30% do not have a National Medicines Regulatory Authority (NMRA) in place.

Over the years, the World Health Organization together with other international organizations and donor countries has been supporting African countries to establish and strengthen their medicine regulatory authorities. Despite the efforts made however situations have not changed much. Some of the reasons for this have been absence of government support, lack of adequate number of trained and qualified staff, high staff turn-over due to low salaries and lack of incentives, inadequate and unsustainable funding of the NMRAs, weak infrastructure.

A conference of African Medicine Regulators held from 30 October–3 November 2005 in Addis Ababa, Ethiopia discussed the medicine regulatory situation in the subregion and came up with the following as the main characteristics: ineffective licensing system, weak product registration, poor inspection practices, inadequate access to quality control laboratories, inadequate market control, non existence of pharmacovigilance and control of promotion, lack of clinical trials, oversight, inadequate communication and information exchange system, lack of transparency and accountability and conflict of interest.

The result is in many of sub-Saharan African countries medicines are imported into the countries or manufactured locally without any appropriate quality assurance safeguards. In addition, in many of these countries medicines are smuggled across borders and sold in open market places and on streets, leading to a high prevalence of sub-standard and counterfeit medicines. Reports indicate that in sub-Saharan Africa, on the average, as much as 30% of samples of medicines tested fail quality tests.

The meeting also identified inadequate government and public support; law status given to NMRA; inadequate number of qualified and skilled staff; lack

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of legislation, regulations, guidelines and procedures; inadequate and unsustainable resources; weak enforcement mechanisms and sanctions and corruption to be the main barriers to the improvement of medicine regulation in the subregion.

The Conference recommended the following strategies to improve medicine regulation in the sub-region:

Take gradual, feasible and realistic steps towards regulationReview and strengthen legislationPut in place an appropriate structure to support effective regulationReview and develop/strengthen regulations, guidelines and procedures to support regulationEstablish mechanisms to ensure financial sustainability of MRAsSet up mechanisms to ensure recruitment, training and maintenance of adequate human resources Put in place advocacy strategies for effective drug regulationImprove IEC for the sensitization of stakeholders, civil societies and the general public to appreciate and support effective drug regulationSet up systems for managing and sharing of informationPut in place mechanisms for monitoring and evaluation of implementation of drug regulation

In conclusion, the Conference developed a five year plan for the development of medicine regulation in the sub-region and recommended that:

Develop and implement strategies to promote effective medicinesregulation. Prepare and submit to WHO/AFRO a 2-year national plan indicating thepriority activities to be undertaken in 2006–2007 to improve medicines regulation.Explore regional collaboration and support the creation of networks to share information on medicines regulation.

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National Medicine Regulatory authorities should:

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Government should:

WHO/AFRO should:

Support medicines regulation and provide adequate funds to NMRAs to perform their functions. Advocate for and support sub-regional and regional harmonization initiatives.Support human resources development for medicines regulation.Institutionalize the development and strengthening of autonomous NMRAs.

Organize a conference for all African Medicines Regulatory Authorities at least once every two years to further the exchange of information and experiences of medicines regulation in the region.Ensure better coordination of medicines regulatory activities in the region. Advocate for countries to establish MRAs and adequately fund medicinesregulation. Strengthen and expand MRA assessments to other countries in the region.Support capacity building and training of MRA staff. Ensure that all existing tools and documents are available in both English andFrench. Promote the exchange and use of technical expertise available in the region.

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1.1 BackgroundCurrently it is estimated that about 30% of the 46 sub-Saharan African countries do not have a National Medicines Regulatory Authority (NMRA) in place. About 7% of the remaining countries have a moderately developed capacity, and that a massive 63% have minimal capacities that hardly function. In most of these countries, NMRAs have an inadequate number of staff that are insufficiently trained and qualified. Staff turn over is high due to low salaries and lack of incentives. In addition, funding is inadequate and unsustainable, infrastructure is weak, and access to independent and objective medicine information is lacking.

Consequently, in many of these countries medicines are imported without any quality assurance safeguards, while those manufactured locally are produced and distributed under deficient manufacturing and distribution conditions. Moreover, medicines are smuggled in and out of the countries and sold in open market places and on streets, leading to a high prevalence of sub-standard and counterfeit medicines. Reports indicate that in sub-Saharan Africa, on the average, as much as 30% of samples of medicines tested fail quality tests. A recent study carried out by WHO showed that more than 50% of samples failed quality tests. In some countries, the prevalence of counterfeit medicines is estimated at 60% of the medicines found in market places.

WHO has been supporting sub-Saharan African countries to establish and strengthen their national medicine regulatory and quality assurance systems for a long time. More specifically, in the past 10 years, WHO in collaboration with other development partners, has organized several training courses and supported the participation of a large number of medicine regulatory officers in conferences and workshops. In addition, a number of initiatives were undertaken to stimulate regional and subregional collaboration in order to complement these activities.

In 2003, WHO initiated a special scheme aimed at providing focused assistance to selected national medicine regulatory authorities, training regulatory officers in the different areas of medicine regulation, promoting subregional medicine regulation harmonization, and establishing centres of excellence for training medicines regulatory officers. For instance, in the last three years, under this

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1.INTRODUCTION

First African Medicines Regulatory Authorities Conference Final Report

scheme, WHO assessed the regulatory systems of six countries in the subregion, identified gaps, developed action plans together with the respective NMRAs and provided financial and technical support to five of them. In addition, it supported existing and new harmonization initiatives and sent out circular letter to countries to express their interest to serve as training centres. The progress made so far under the scheme is encouraging, but a lot more needs to be done to make them operate effectively and efficiently.

In order to discuss the status of medicine regulation in the subregion, identify the weaknesses, strengths and barriers, and to develop strategies that will help improve medicine regulation, a joint PSM-TCM-WHO/AFRO Conference of African Medicine Regulators was held from 30 October–3 November 2005 in Addis Ababa, Ethiopia.

The conference participants were the heads of National Medicine Regulatory Authorities from 33 countries—Angola, Benin, Botswana, Burkina Faso, Cameroon, Chad, Comoros, Republic of Congo, Côte d'Ivoire, Ethiopia, Equatorial Guinea, Gambia, Ghana, Guinea, Guinea-Bissau, Kenya, Madagascar, Malawi, Mali, Mozambique, Namibia, Niger, Nigeria, Rwanda, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Tanzania, Togo, Uganda, Zambia and Zimbabwe.

WHO was represented by staff from TCM/WHO, QSM/PSM, IVB/WHO, EDM/AFRO, WHO/AFRO and National Programme Officers (NPOs) of WHO Country Offices of Cameroon, Ethiopia, Senegal, Tanzania and Uganda.

Mr Eshetu Wondemagegnehu, QSM/PSM, briefed participants on why the conference had been called and on the objectives and expected outcomes. He highlighted the current situation of medicines regulation in sub-Saharan Africa, which is characterized by a weak regulation of medicines in the majority of countries, leading to unapproved/unregistered medicines circulating in the market, smuggling of medicines across borders, high prevalence of substandard

1.2 Participants

2. OPENING OF THE MEETING

2.1 Introduction to the conference

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and counterfeit medicines and unapproved/unmonitored activities such as clinical trials, promotion and advertising of medicines as well as poor dispensing of medicines.

Mr Wondemagegnehu also outlined some of the barriers to effective medicine regulation in the Region, which included, among other, weak political support and commitment to establish/strengthen medicine regulatory systems, inadequate numbers of appropriately trained and motivated staff, inadequate and non-sustainable financing, outdated legislation and guidelines, lack of transparency in the decision-making processes and conflict of interest. He outlined the objectives and expected outcomes of the conference as follows:

Overall objectiveTo promote effective medicines regulation in the subregion in order to ensure that medicines used by people in the subregion are safe, efficacious and of good quality.

Specific objectivesDiscuss the medicines regulation situation in sub-Saharan Africa and identify strengths and weaknesses, priority problems and solutions.Develop a five year strategic plan for the subregion to address the problemsIdentify priority activities to be undertaken during the plan period by the Region.Each country represented in the meeting was to develop a national strategic plan by identifying the strengths and weaknesses of its national medicines regulatory system, and solutions to address the problems and.Develop a strategic plan for 2006–2007.

Expected outcomesRecommendations on how best to address the problems of medicines regulation in sub-Saharan Africa to be formulated, discussed and agreed upon.A five-year Regional Strategic Plan be developed and main activities identified, discussed and adopted.Recommendations on how best to promote harmonization of medicine regulation in sub-Saharan Africa to be formulated, discussed and adoptedA two-year National Action Plan to be implemented by each National Medicines Regulatory Authority be developed and submitted.

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2.2 Welcome address

2.3 Official Opening of the Conference

Following the introduction, Dr Nicholas Eseko, Acting WHO Representative, Ethiopia, welcomed participants to Ethiopia and thanked the organizers for choosing Ethiopia as the venue for this important conference. He reminded participants of the special nature of medicines which should not be treated as ordinary commodities and their crucial role in the delivery of health care. He commended WHO for the support it has rendered to many countries in sub-Saharan Africa to establish and strengthen NMRAs. He also noted that although a lot of progress has been made in the subregion with regard to medicines regulation and control, studies have shown that many MRAs in Africa have a low functional capacity and there are still some Member States with no MRAs. This has led to the circulation of sub-standard and counterfeit medicines in the subregion, which is a major public health concern to all Member States.

Dr Eseko appreciated the relevance and timeliness of the conference, which he hoped would go a long way in promoting effective medicines regulation in the subregion. He expressed confidence that the objectives of the conference would be achieved and wished all the participants fruitful deliberations.

The meeting was officially opened by Mr Hailesellassie Bihon, General Manager of the Drug Administration and Control Authority (DACA) of Ethiopia on behalf of the Minister of Health of Ethiopia. In his speech, Mr Bihon, welcomed the participants to the conference and thanked WHO for choosing Ethiopia to host it. He noted that the provision of quality health services is not possible without availability and equitable access to safe, effective and quality medicines. He elaborated on the steps that Ethiopia has taken to implement the National Drug Policy and the special attention the Government of Ethiopia has given to strengthening the pharmaceutical sector, especially witnessed in the growth of the local manufacturing capacity, from one to more than a dozen local pharmaceutical manufacturers in a period of about 10 years.

Mr Bihon told the participants that given the high burden of disease, the low manufacturing capacity and weak medicines regulatory systems in many African countries, MRAs must build strong partnerships among themselves and with their allies to reduce the consequences of the diseases prevalent in the continent and ensure sustainable development for the people. He noted that the lack of effective and strong medicines regulatory systems in Africa posed a challenge in


ensuring that medicines used by the health services are safe, effective, of good quality and rationally used. To achieve this would require that each country present in the meeting establish and sustain a strong and independent medicines regulatory body.

Mr Bihon thanked WHO for the support given to strengthen the medicines regulatory capacity in Africa in general and to DACA in particular. He expressed hope that the meeting would yield useful results with the benefit of improving the regulatory situation, and therefore contribute to increasing the availability and access to safe, effective, and quality medicines in Africa. With these words, he wished the participants productive and successful deliberations and then declared the meeting officially open.

In her speech, Mrs Malebona Matsoso, Director of the Department of Technical Cooperation for Essential Drugs and Traditional Medicines, (TCM/WHO) noted that in spite of the progress made, the health status of the world's population, especially in Africa, remains a big challenge. The high burden of disease in Africa, with its weak and fragmented health systems continued to pose a serious challenge to the attainment of the Millennium Development Goals (MDGs).

She highlighted the opportunities available through the support of international organizations/partners such as the WHO pre-qualification project and the focus by regional bodies such as the African Union (AU) and the New Partnership for Africa's Development (NEPAD) to strengthen health systems, including the regulation of medicines.

Mrs Matsoso called upon the participants to “do the right things first”—those that demonstrate added value and doing them right with available resources that can help to achieve the broad objectives of improved access to essential medicines. She reiterated WHO's commitment to provide guidance and technical support to Member States in this regard and wished the participants fruitful deliberations during the conference.

The opening ceremony was followed by administrative announcements, self-introduction by participants, approval of the conference programme and election of officers. The following were elected for the different offices:

2.4 Message from WHO/HQ

2.5 Administrative arrangements


ChairsMrs Margareth Ndomondo Sigonda, Director General, Tanzania Food and Drug Authority (TFDA), TanzaniaDr Maiga D. Minkaila, Director, Division of Medicine and Pharmacy (DMP), Mali

RapporteursDr Wynn Charles Chalira, Registrar, Pharmacy and Poisons Board, MalawiDr Safiatou Ouattara, UEMOA, Burkina Faso

Support groupMr Joseph, Serutoke, NPO, UgandaMs Rose Shiga, NPO, Tanzania Dr Ngono Mballa Rose, NPO, CameroonDr Ngom Mamdou, NPO, Senegal.

The conference was divided into morning and afternoon sessions consisting of plenary and workshop discussions. The plenary sessions entailed presentation of papers followed by discussions.

The participants were divided into two working groups, French and English speaking, to discuss the workshop themes. Each theme was discussed by both groups separately. Findings of the group works were then presented at plenary session for discussion. Simultaneous French and English translations were provided during plenary sessions. A summary of the day's discussions was presented at the plenary meeting of the next day for discussion and agreement.

(Dr Jean-Marie Trapsida, EDM/AFRO)

Dr Jean-Marie Trapsida presented an overview of the medicines regulation situation in sub-Saharan Africa. He outlined the functions of MRAs, which include licensing of persons and companies dealing in medicines, granting of marketing authorization, authorization of clinical trials, inspection of manufacturers and distribution outlets, monitoring the quality and safety of medicines and control of promotion and advertising of medicines.

3. METHOD OF WORK

4. MAIN TOPICS PRESENTED AND DISCUSSED AT PLENARY4.1 Medicine regulation in sub-Saharan Africa: an overview


He identified some of the major problems affecting medicines regulation in Africa as:

lack of understanding by policy makers on the need to regulatemedicines, leading to inadequate political support and commitment,inadequate legislation and regulations, inadequate structures and staff in terms of numbers, professional diversity and training,low salaries and lack of incentives,inadequate and non-sustainable funding.

He said that these problems result in undesirable consequences such as:

circulation of unregistered, sub-standard and counterfeit medicines in the market,non-GMP compliant manufacturing activities,unapproved/unmonitored activities such as clinical trials, promotions and advertising of medicines.

Dr Trapsida listed the initiatives taken by WHO to strengthen medicine regulation in the Region and the positive outcomes from these interventions as follows:

technical support to promote harmonization efforts in the SADC, UEMOA and EAC subregions, capacity building based on results of assessment of medicine regulatory systems, installation and use of SIAMED, conducting training courses for GMP inspectors and quality control laboratory staff, etc.

He noted that improvements have been made in medicines regulation in some countries where interventions have been based on joint planned activities. He ended his presentation by calling upon the cooperation of all MRAs to improve the medicines regulation situation in Africa.

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4.2 Country initiatives to promote effective medicine regulation

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Ethiopia

(Mr Abraham G. Kahsay)

Medicine regulation was first established legally in the late 1960s as Pharmacy Division under the Ministry of Health of Ethiopia. In 1999, a new structure was created as an independent authority under the name Drug Administration and Control Authority (DACA). It became operational in 2001. DACA reports to a Board. Fifty-five percent of the working budget comes from central treasury, 12% from fees collected for services and the rest comes from development partners. It has one branch office in the southern part of the country and others are to be opened in the near future. The workforce consists of 60 technical and 50 administrative staff.

DACA's scope of activities as defined by Proclamation 176/1999 include the following:

Setting standards of safety, efficacy, quality for drugs and traditional medicines as well as for competence of pharmaceutical organizations.Formulation of policy governing the sector.Preparation of list of drugs and categorization and revision of the list as necessary.Issuance of license to manufacturers, importers, wholesalers, retail outlets, etc.Registration of drugs for human and animal use, medical supplies, equipments, pesticides, etc. Licensing and inspection of pharmacy establishments. Investigation of the quality of drugs, medical equipment, supply, raw materials.Provision of current and unbiased drug information to professionals and the public.Control of drug advertisement and promotion.Issuance of license for clinical trials.

Côte d'Ivoire (Dr Assi-Gbonon Rosalie, Director, DPM)

The Directorate of Pharmaceutical Services (DPM) was created in 1969 and has undergone several changes since then to an authority which is under the Directorate of Health Practices in the Ministry of Public Health and Population from 2002. It has a well-established structure and is fully dependent on financing from the Government.


The scope of work includes regulation and control of pharmacy practice, drug registration, manufacturing, import and export regulation, control of drug advertising, inspection of pharmaceutical firms, pharmacovigilance activities, control of narcotics and clinical trials. The organization has 11 technical staff and seven administrative staff. It has so far been able to develop various guidelines for the regulation of the pharmaceutical sector (manufacturing, inspections and registration), register all pharmaceutical products on the market, develop the essential drugs list (EDL), carry out inspections including good marketing practices (GMP) and the assessment of counterfeits which are impounded and destroyed.

The Drugs Regulatory Agency (DRA) has several constraints mainly in the area of inadequate infrastructure, transport, human and financial resources. During the next five years, the Directorate of Pharmaceutical Services of Côte d'Ivoire intends to concentrate on creating a legal framework to ensure independence of the DRA, training of staff in all aspects of regulation, pharmacovigilance, public education on the dangers of illicit (street) drug sales, adequately fighting counterfeits and creating a website for the agency.

Democratic Republic of Congo (Mr Franck Biayi Kanumpepa, Director, Directorate of Pharmacy, Medicines and Medicinal Plants)

The Drugs Regulatory Agency of the Democratic Republic\ of Congo was created in 1951. It has undergone several changes to attain its present status of the Directorate of Pharmacy, Medicines and Medicinal Plants, in 2002. It is fully dependent on Government for financing its activities and it operates as a department under the Ministry of Health. The DRA has a very limited budget that makes it very difficult to cover the entire country due to its vast size. It has a well-established structure with various departments (registration, drug control, quality control, cosmetics control and herbal medicines) consisting of a total of 35 technical staff and 37 administrative staff. The main activities include authorization of importation and exportation of medicines, market authorization for medicines, inspection of pharmaceutical outlets and manufacturers, licensing of premises and quality control of medicines.

The DRA has so far managed to register all locally manufactured medicines, and those that are imported into the country. Twenty-five percent of the local manufacturers are compliant to good marketing practices. During the next five years, focus will be on mobilizing resources (both financial and human to carry


out their work effectively), training of staff in QC, GMP and GDP, and evaluation of the capacity of the Directorate.

Mali (Dr M. Maiga, Director, DPM)

The Directorate of Pharmacy and Medicines (DPM) was created in 2000 (before this, medicines regulatory functions were handled by the Health Inspectorate, the QC Laboratory and the Directorate of Health in the Ministry of Health) with the essential task of coordinating all activities in the pharmaceutical sector and to carry out medicines regulation. The DPM is fully dependent on Government financing but also receives funds for activities from technical partners. It has 11 technical staff and seven support staff and works together with other departments such as the QC Lab, GMP and clinical trials that are in the Ministry of Health.

The DPM's scope of work includes drug registration (human, veterinary and herbal medicines), regulation and certification of pharmacy practice and licensing of premises and manufacturers. The regulatory functions of GMP inspections, clinical trials controls and QC of medicines are carried out by the Inspectorate, Clinical Trials and QC laboratory departments respectively. The DRA of Mali has been able to register all the products imported in the country, create a website (with support from WHO), install a computerized drug registration system (SIAMED), develop guidelines for registration and distribution of medicines, and set up a multisectoral committee for coordination of the fight against the illicit sale of medicines. They still face many challenges due to inadequate staffing, funding and failure to control imports and the illicit sale of medicines in markets/streets. Over the next five years the DRA of Mali will focus on training of inspectors, implementation of regular effective GMP inspections, regulation of medicines' advertisement, regulation of clinical trials and strengthening the National Health Laboratory for QC of biological and medical devices.

Senegal (Dr M. Ngom EDM/NPO on behalf of Pr M. Badiane, Director, DML)

The Drugs Regulatory Agency of Senegal was established as the Department of Pharmacy and Laboratories (DPL) in 2003 and is fully dependent on Government for financing. It has a well-established structure with various departments—Registration, Administration, Narcotics and Psychotropic substances, Monitoring of ADRs, Registration of Pharmacy-related Businesses and Control/Release of vaccines. The DPL is charged with regulating the


pharmaceutical sector and practice, registration of medicines, quality control of medicines, promoting rational use of medicines, and pharmacovigilance activities. Their major achievements have been recorded in the development of policies, training manuals, guidelines and procedures for the management of medicines, sensitization of health professionals and consumers on rational use of medicines, registration of all imported and locally produced medicines, inspection of pharmaceutical outlets, and development of a website (on-going).

The DPL still has challenges resulting from inadequate funding, lack of personnel, technical equipment and logistics, and control of illicit sale of medicines in markets. Over the next five years, emphasis will be on training of DRA staff in pharmacovigilance, good marketing practices and good distribution practices, mobilizing financial resources, control of the illicit market, and strengthening the quality control and Inspection departments (see also Annex 3.2.6).

Tanzania (Mrs Margareth Ndomondo Sigonda, Director General, TFDA)

The Tanzania Food and Drugs Authority (TFDA) was established in 2003 from the former Pharmacy Board of Tanzania. It is an executive agency under the Ministry of Health, which is responsible for the regulation of food, drugs (including herbal medicines), cosmetics, medical devices and clinical trials. It has 83 staff responsible for control of food, drugs, cosmetics and medical devices in the departments for Inspection and Surveillance, Product Evaluation and Registration, Business Support Services and Laboratory Services.

Their scope of work involves drug registration (including herbal drugs), registration and licensing of pharmaceutical manufacturers, importers, wholesalers and retailers, drug quality control, pharmacovigilance, control of medicines' promotion, advertising and clinical trials.

TFDA has recorded some achievements in developing essential guidelines for drug regulation, a web site, using minilab centres which have been opened throughout the country for primary screening of drugs using GPHF Minilab Kits, establishment of interlinked databases for drug registration, inspection and quality control. The QC lab has been rated good in proficiency testing organized by WHO.

Major gaps still exist in the lack of linkages to zonal offices, inadequate human and financial resources, insufficient laboratory equipment, reference standards and the capacity to carry out method validation and analysis of vaccines. Their


five-year plan focuses on conducting public education programmes, instituting a quality management system to attain ISO certification, strengthen inspectorate, pharmacovigilance and QC departments, develop in-house capacity to evaluate new chemical entities, develop specific guidelines for regulating vaccines and herbal medicines and combating counterfeit drugs.

Uganda (M. Apollo Muhairwe, Executive Secretary/Registrar, NDA)

Uganda's DRA, the National Drug Authority (NDA) was established to its present status in 1993. Hundred percent of its working budget comes from fees collected against the services it provides. It has four regional offices (two zonal offices are being set up) with a total of 42 technical staff and 30 administrative staff. The NDA is charged with the registration of drugs (includes herbal drugs, food supplements and public health chemicals), licensing of pharmaceutical premises including manufacturing, quality control of drugs, pharmacovigilance and vetting of pharmaceutical promotional materials and activities.

The main achievements have been in the registration of locally produced products (81%) and those imported (94%). The remaining 6% are authorized for importation under a special provision of the law. Another achievement is in the licensing of premises for pharmaceutical operations (55%) of local manufacturers comply with GMP, 80% of importers and wholesalers comply with GDP and 76% of retail outlets comply with NDA regulations. The NDA's major gaps include post-marketing surveillance at the district level and the capacity of the National QC laboratory, which is limited.

During the next five years, focus is set on training staff in QC, expanding the National QC laboratory to perform microbiological analysis, registration of medical devices and control of clinical trials.

Zimbabwe (Mr M.N. Dauramanzi, MCAZ General Manager)

The DRA of Zimbabwe is referred to as the Medicines Control Authority of Zimbabwe (MCAZ) and was established to its present status in 1997 from the Drugs Control Council, which was first established in 1969 under the Ministry of Health and Child Welfare. It is an autonomous body and it reports to the Minister of Health and Child Welfare through a Board. Hundred percent of its working budget is derived from fees collected for services. The MCAZ has one sub-office, 25 technical staff and 27 administrative staff.


It is charged with the licensing of manufacturers, wholesalers, retail outlets, industrial clinics, dispensing doctors and veterinary surgeons, registration of medicines, inspection of pharmaceutical premises and animal medicines, control of clinical trials and QC of drugs and medical devices.

The MCAZ has been able to develop, print and distribute all the essential guidelines for medicines regulation (currently undergoing review). Furthermore, it has registered all locally produced products, and ensures that the majority of all those involved in pharmaceutical operations are GMP and GDP compliant. However the organ still experiences challenges due to inadequate human and financial resources, lack of legislation to control import and export of drugs, and a weak post-marketing surveillance system for medicines. Over the next five-year period, the MCAZ will focus on updating their legislation, developing capacity to control medical devices, control of complementary medicines, strengthening the information technology unit and post-marketing surveillance, expanding the laboratory services to include complementary medicines analysis, expanding the revenue base and will seek International Accreditation (ISO 17025).

(Mr Eshetu Wondemagegnehu, QSM/WHO)

Mr Eshetu Wondemagegnehu presented a concept paper outlining the path that countries may have to follow in developing their national regulatory systems. He said building an effective medicine regulation is not an easy task since it involves issues that are political, legal and technical in nature. Implementation of medicine regulation requires scientific and technological knowledge and skills, which may not be easy to find in most countries, developing countries in particular. In many countries, problems and issues related to medicines are barely understood by governments and the general public. Consequently, government and public support is minimal. On the other hand, because the regulated firms are better organized, financially strong and have better scientific and technological knowledge and skills, they have better opportunities to apply pressure on politicians to change regulatory decisions.

4.3 Medicines regulation development path: concept for discussion


Mr Wondemagegnehu recommended a phased (step-by-step) approach for countries starting to build a medicine regulatory system and outlined the following main phases:

Preparatory phase—establishing a medicine regulation taskforce to study thesystem and propose activitesConsensus building phaseStructure building phase- Establish a transitional medicine regulatory body—step1- Appoint leaders and create the authority by law—step 2

Implementation phase (4 Steps)

To ensure sustainable development in medicine regulation, countries are required to introduce a regular assessment system into their medicine regulation. Managers of medicine regulation should have a clear vision on which direction they would like to go and the level they would like to achieve within a given period.

(Mrs Malebona Matsoso, Director, TCM/WHO)

Mrs Malebona Matsoso, Director TCM/WHO outlined the different dimensions of medicines regulation, the regulatory barriers which impact on access to medicines, specific regulatory problems, and some possible solutions for improving medicines regulation.

She pointed out some of the regulatory barriers affecting access to medicines. These were identified in a WHO survey of 11 African countries in 2005, and included lack of an enabling environment (legal framework), technical elements (lack of guidelines, registration delays and backlogs, lack of transparency in decision making) and lack of political commitment. According to Mrs Matsoso, these barriers are further compounded by submissions of poor quality and/or insufficient data, unsubstantiated claims and duplicitous marketing of medicines by the pharmaceutical industry in situations where the National Medicines Regulatory Authorities lack adequate numbers of skilled staff and funding to carry out their functions.

§

§§

§

4.4 Revamping medicines regulation to respond to public health priorities


In conclusion, she recommended some regulatory frameworks and structures that can be developed and used as possible solutions to effective medicines regulation, emphasizing that each NMRA should perform self-assessments and develop an institutional development plan. This should take into account the available human and financial resources. She also proposed harmonization as one of the ways in which medicines regulation can be improved through collaboration and sharing of information between different NMRAs within the subregion.

Experiences Southern Africa Development Community harmonization

(Ms Gugu N. Mahlangu)

Ms Gugu Mahlangu presented the experience of harmonization of medicines regulation within the Southern Africa Development Community (SADC). She outlined the historical development of harmonization within the SADC unto the point at which it was firmly placed on its (SADC's ) agenda in 1999. Two working groups—one for the registration of medicines led by South Africa and the other on drugs control led by Zimbabwe—were formed to carry out the work. She noted the political will and commitment availed to the working groups by the member states of SADC, which was mainly based on their need to improve access to medicines in the region. With external support from WHO and DFID, the SADC Member States, led by the Medicines Control Council of South Africa, shared the responsibilities of developing the various guidelines for the different regulatory functions.

Ms Mahlangu highlighted the achievements made so far in drafting and adoption of harmonized application forms and guidelines for registration of medicines, bioequivalence and bioavailability, stability testing, GMP and clinical trials. However, she noted that there are still various challenges that need to be addressed by SADC, which include the publication and implementation of the guidelines, the creation of a sustainable and fully-funded structure to guide the process including appointing a focal person for pharmaceutical issues in the SADC secretariat and the development of regulatory capacity that is consistent with the available resources.

4.5 Medicine regulation harmonization in Africa


East African Community harmonization

Monetary and Economic Union of West Africa harmonization

(Dr Nditonda Chukilizo)

Dr Nditonda Chukilizo gave the experience of the East African Community (EAC) Member States. He outlined the composition of the EAC (Kenya, Uganda, Tanzania) and the conducive legal and institutional framework available through the EAC Treaty of 1999 that provides for areas of cooperation and establishes the organs of the community. The three Member States' Medicines Regulatory Authorities (MRAs) envision ending up with an EAC Food and Drug Regulatory Authority.

He informed the participants that most of the guidelines that have been adopted by the EAC are based on WHO guidelines. The presence of a legally binding treaty between the three Member States of the community, a common language (Kiswahili) and the similar legislation and level of development of the MRAs are positive factors that are greatly enhancing the harmonization efforts of this subregion. Dr Chukilizo enumerated the gaps/challenges still faced by the EAC such as the inadequate capacity of the MRAs, absence of a focal person within the EAC secretariat, inadequate funding leading to limited contacts of technical committees, involvement of members of the EAC in other regional initiatives (SADC, COMESA) and the lumping together of medicines regulation with other activities in the EAC Charter.

(Dr Safiatou Ouattara)

Dr Ouattara presented the experience of medicines regulation harmonization from the Economic and Monetary Union of West Africa (UEMOA). She listed the members as Benin, Burkina Faso, Côte d'Ivoire, Guinea-Bissau, Mali, Niger, Senegal and Togo. She highlighted the factors that have been conducive in the harmonization efforts such as the strong political will in setting up the bloc, the common currency, languages and similar disease patterns across the union.

With WHO support, UEMOA held the first technical meeting of drugs regulatory authorities in March 2003 and drafted a Memorandum of Understanding (MOU) on harmonization of drug regulations. A second technical meeting was called by the UEMOA, followed by the meeting of Ministers of Health who adopted the MOU in August 2004. In January 2005, the Ministers of Finance endorsed the MOU.


UEMOA has since been able to standardize quality control standards, the registration of generics and other medicines and exchange of information within the Union. A planning meeting is scheduled for early 2006 to set up a secretariat that will coordinate:

Validation of quality of medicines

Value Added Tax (VAT) and other taxes on imported medicines and raw materials

Harmonization of registration of pharmacies and pharmacists.

A draft proposal has been prepared by the WHO in order to mobilize funds to enable UEMOA to set up the Secretariat which will handle the harmonization process.

(Mr Ben Botwe)

Mr Botwe presented the harmonization initiative from the Economic Community of West African States (ECOWAS). He identified the challenges faced within ECOWAS as poor/outdated medicines legislation, uncontrolled distribution of medicines including traditional medicines, different languages and cultures, the existence of parallel initiatives within the same bloc (UEMOA) and inadequate funding.

He noted that the bloc has agreed on a vision and mission and identified priority activities to be undertaken which include harmonizing the requirements for drug registration, labelling, inspections and licensing and pharmacovigilance. Support is needed in order to draft common agreements and a Memorandum of Understanding (MOU), perform an assessment of the MRAs, develop a training manual and design a website for the initiative. Mr Botwe ended his presentation by stating that ECOWAS is now seeking support from WHO and WAHO. The West African Pharmaceutical Manufacturers Association (WAPMA) has indicated interest in participating and supporting the initiative.

§

§

§

Economic Community of West African States harmonization


Economic Community of Central Africa States harmonization

International Conference on Harmonization of Technical Requirements for Drug Registration (ICH)

(Dr Peyou Ndi Marlyse)

The presentation by Dr Peyou Ndi Marlyse was on the experiences of Communauté Economique des Etats de l'Afrique Centrale (CEAC). She reported that harmonization was encouraged by efforts to control common diseases within the bloc. Activities included cover national drug policies, adoption of harmonized regulations, improvement of drugs procurement and price controls.

The challenges faced by the group include the setting up of a technical working group to elaborate the priority areas for cooperation (human resource development, quality control, management of donations, improved exchange of information, regulatory and drug procurement procedures), training needs, a common legal framework for scheduling of medicines in particular and performing a baseline situational analysis. The initiative is progressing and the next meeting of CEAC is planned for early 2006.

(Dr Lembit Rago, QSM/PSM)

Dr Lembit Rago presented the set up of ICH, its members and the factors that have contributed to its success. These include ICH addressing primarily new pharmaceutical products, limiting its membership to six parties, and employing a consensus building activity based on the close relationship between the different working groups who review the differences in requirements among the three ICH regions and develop harmonized guidelines for adoption.

ICH members represent the largest pharmaceutical trade block (76% of the world pharmaceutical market) and these countries are also the world leaders in producing innovator products through pharmaceutical research and development (R & D). ICH members benefit through considerable reduction in the duration of approval of products within Member States. Non-ICH members may be invited to ICH meetings as observers while WHO represents the interests of other Member States during ICH meetings.

Dr Rago also outlined the different regulatory paths to assure quality, safety and efficacy of medicines for public health needs in the developing world. These


19

include the WHO pre-qualification project; United States Food and Drug Administration (FDA); tentative approval process for ARVs, the EU Article 58 and other legislative initiatives to approve generics under compulsory license for export (Canada and Norway).

Article 58 of Regulation (European Commission) No 726/20041 establishes a mechanism whereby the European Medicines Agency (EMEA) may give a scientific opinion, in the context of cooperation with WHO, for the evaluation of certain medicinal products for human use intended exclusively for markets outside the Community. He concluded his presentation by reminding participants that the world is moving towards trusting one another based on transparency and understanding of regulations and procedures. This calls for carrying out activities that add value to the patient so as to enable the scarce resources to be of real value to medicines regulation.

Working group discussions presented at plenary on harmonization of medicine regulation in Africa: Strengths and weaknesses

Participants were divided into two working groups and discussed the strengths and weaknesses of MRAs in Africa with regard to harmonizing their medicines regulation. The groups also made proposals on the steps that should be followed to implement harmonization initiatives and the roles of the different stakeholders in the process.

The working groups appreciated the need for harmonization of medicines regulation, which would lead to optimization of resources and expertise within a subregion, uniform implementation strategies with common requirements, guidelines and procedures for medicines regulation and quick access to medicines to support public health. Countries would take advantage of the economies of scale created through the free movement of medicines within larger markets.

The following were identified as the major strengths, weaknesses and barriers for harmonization of medicines regulation within the region. Additionally, necessary steps to carry out the harmonization were proposed.

Implementation

1. http://mednet3.who.int/prequal/2. http://www.fda.gov/bbs/topics/news/2005/NEW01152.html3. http://www.emea.eu.int/pdfs/human/bwp/557904en.pdf

First African Medicines Regulatory Authorities Conference Final Report

Wo

rkin

g g

rou

p f

ind

ings

1.

Exis

tence

of

regi

onal

eco

nom

ic

blo

cks,

EA

C,

SAD

C,

ECO

WA

S, U

EMO

A, C

OM

ESA

, etc

.

2.

Polit

ical

w

ill

thro

ugh

th

e

above

-mentioned

eco

nom

ic

grou

ps.

3.

Exis

ting

initia

tive

s to

lear

n fr

om

e.g

. ASE

AN

, EU

, SA

DC

.

4.

Exis

ting

guid

elin

es:

WH

O, I

CH

.

Str

en

gth

s an

d o

pp

ort

un

itie

s

Barr

iers

1.

Lack

of

info

rmat

ion e

xchan

ge m

ech

anis

ms

e.g

. IT

shar

ed

w

eb

site

s/p

oin

ts.

2.

Diffe

rent l

egi

slat

ions in

diffe

rent c

ou

ntr

ies.

3.

Diffe

rent l

angu

ages an

d c

ultu

res.

4.

Diffe

rent l

eve

ls o

f deve

lop

ment o

f cou

ntr

ies an

d M

RA

s.

Weakn

ess

es

1.

Weak

MR

As w

ith li

mited

hu

man

and

finan

cial

reso

urc

es.

2.

Par

alle

l and

ove

rlap

pin

g har

moniz

atio

n in

itia

tive

s.

3.

Lack

of s

tru

ctu

res to

coord

inat

e h

arm

oniz

atio

n in

itia

tive

s, e

.g. S

ecr

eta

riat

.

4.

Inad

eq

uat

e e

xchan

ge o

f info

rmat

ion a

nd

exp

eri

ence

s.

5.

Lack

of

a co

mm

on u

nd

ers

tand

ing

of

the t

rue m

ean

ing

and

vis

ion/g

oal

s of

har

moniz

atio

n.

6.

Lack

of p

olit

ical

com

mitm

ent.

7.

Lack

of c

om

mitm

ent f

rom

MR

As.

8.

Lack

of s

ust

ainab

le fu

nd

ing.

Ste

ps

to c

arr

y o

ut

harm

on

izati

on

1.

Bu

ild tr

ust

and

com

mitm

ent a

mong

tech

nic

al p

eop

le to

war

ds har

moniz

atio

n.

2.

Secu

re p

olit

ical

com

mitm

ent a

nd

su

pp

ort

.

3.

Car

ry o

ut s

itu

atio

n a

nal

ysis

and

identify

gap

s.

4.

Define th

e v

isio

n a

nd

goal

s of h

arm

oniz

atio

n.

5.

Set u

p a

dm

inis

trat

ive str

uct

ure

s/se

creta

riat

.

6.

Deve

lop

com

mon str

ategi

es.

7.

Deve

lop

com

mon te

chnic

al re

qu

irem

ents

, sta

nd

ard

, gu

idelin

es,

pro

ced

ure

s.

8.

Up

dat

e le

gisl

atio

ns.

9.

Exch

ange

info

rmat

ion.

20

Firs

t A

fric

an M

edic

ines

Reg

ulat

ory

Aut

hori

ties

Con

fere

nce

Fina

l Rep

ort

The w

ork

ing

grou

ps

pro

pose

d t

he f

ollo

win

g ro

les

for

the d

iffe

rent

stak

ehold

ers

:

•Se

cure

go

vern

ment

polit

ical

sup

port

and

com

mitm

ent.

•Se

cure

th

e

will

ingn

ess

an

d

com

mitm

ent o

f tech

nic

al sta

ff

to th

e h

arm

oniz

atio

n p

roce

ss.

•D

iscu

ss a

nd

ad

op

t co

mm

on

re

qu

ir

em

en

ts

a

nd

p

roce

sse

s—w

hat

can

b

e

done t

oge

ther, w

hat

can

be

shar

ed

.

•Se

t u

p a

n a

uto

nom

ou

s M

RA

wit

h

cle

ar

man

date

fo

r m

ed

icin

es re

gula

tion.

•D

eve

lop

a c

apac

ity

bu

ildin

g

pla

n.

Co

un

try

•C

oo

rdin

ati

on

o

f m

em

ber

stat

es.

•S

et

up

a

fu

nc

tio

na

l

Secr

eta

riat

.

•Sh

arin

g an

d

exc

han

ge

of

info

rmat

ion.

•R

ess

ou

rce m

ob

iliza

tion.

•A

dvo

cacy

.

Su

bre

gio

nal gro

up

•Te

chnic

al a

nd

finan

cial

sup

port

.

•A

dvo

cacy

.

Part

ners

•Te

chnic

al su

pp

ort

.

•C

oord

inat

ion

of

par

tners

an

d

pro

cess

es.

•Su

pp

ort

n

etw

ork

ing

am

on

g

MR

As an

d su

bre

gional

gro

up

s.

•D

isse

min

ate

info

rmat

ion

an

d

best

pra

ctic

es

Set

up

sys

tem

s to

fa

cilit

ate s

har

ing

of

info

rmat

ion

(har

ed

-poin

ts, w

eb

site

s).

WH

O

21

Firs

t A

fric

an M

edic

ines

Reg

ulat

ory

Aut

hori

ties

Con

fere

nce

Fina

l Rep

ort

4.6 Effective law enforcement and regulation of distribution

4.7 Ethical practice, conflict of interest, code of conduct in medicine regulation

(Mrs Malebona Matsoso)

Mrs Malebona Matsoso gave a presentation on effective law enforcement and regulation of the distribution chain. She shared with the participants a short video film on the problem of street vendors in Burkina Faso, which highlighted the challenges and complexities of managing medicine distribution channels with respect to illegal/unlicensed premises, unregistered medicines, expired medicines and poor dispensing practices.

Mrs Matsoso emphasized the need for countries to address this problem through a systematic approach and implement strategies, which would improve the procedures for distribution of medicines. Medicine vendors, who provide access to medicines critical in under-served areas, should be empowered through training and licensing so that they can provide good quality services. There is a need to improve coordination with other law enforcement agencies to control and close illegal medicines distribution outlets. She concluded by noting the need to strengthen post-marketing surveillance and sensitization of communities against the dangers of obtaining medicines from illegal/unlicensed outlets.

(Mr Eshetu Wondemagegnehu)

Mr Eshetu Wondemagegnehu's presentation was on the code of conduct/ethical practices and conflict of interest in medicines regulation. He noted that the regulation of medicines is a key societal function that must be managed in the best interests of the public, emphasizing the need for transparency and accountability. He pointed out the two types of interaction that medicine regulators have with stakeholders as:

(a) with the public, patients and consumers, which focuses on education, promotion of awareness and provision of advice and information and characterized by low potential for conflict of interest or corruption, and

(b) with the regulated firms in the course of controlling private activities, provision of services and decision-making where the potential for conflict of interest and corruption is high.

He enumerated several examples of situations where conflict of interest could arise in medicines regulation. These include acceptance of money by MRA staff


to write positive inspection reports, leakage of confidential information from drug registration dossiers to competitors and receipt of gifts to influence regulatory decisions. He cited some causes of this, which include the lack of guidelines and control measures, poor staff remuneration, and the weak rule of law. Corruption has negative effects on medicines regulation as it erodes institutional capacity. This is characterized by disregarding procedures, wasting resources, and hiring or promoting staff with no regard to performance.

Mr Wondemagegnehu concluded his presentation by providing some strategies that can be set up to minimize corrupt practices. Among these would be guidelines on handling of confidential information. Ethical practices must be seen to be practiced in addition to use of external audits and peer review, which must be a part of institutional governance.

Dr Trapsida gave a presentation on the rapid alert system on quality of medicines. He gave the historical background to the initiative, which started in 1997 when WHO convened a meeting of medicines regulation experts in 1997 in Harare, Zimbabwe. A plan of action for quality testing of medicines was developed and the results of these tests would be published and disseminated within the region. He noted that due to some technical difficulties the initiative did not take off as planned.

He proposed areas of information exchange to include reports of counterfeit medicines, adverse drug reactions, registration status of products and manufacturers, and GMP inspection reports. The main requirement for this to take place would be MRAs' access to the Internet and creation of MRA web sites. Information would be collected from WHO, pharmaceutical industry, MRAs and drug quality control laboratories.

Dr Trapsida concluded by calling upon all MRAs to develop web sites in order to facilitate the exchange of information and reiterated WHO's support in this regard.

(Dr Lembit Rago)

Dr Rago presented the framework convention to combat counterfeit medicines. He noted the various aspects of counterfeit medicines that would include an

4.8 Rapid alert system on quality of medicines

4.9 Counterfeit medicines: framework convention


(Dr Jean-Marie Trapsida)

inadequate quantity or lack of active ingredients, and correct or wrong ingredients made with fraudulent intentions. Counterfeiting of medicines is now a major problem throughout the world and since 1985, WHO has taken the lead in addressing it.

He revealed some of the contributing factors to proliferation of counterfeits, which are poorly developed distribution channels where the counterfeits bypass the official/licensed channels. Added to this is the evolution of the Internet and trade liberalization.

Dr Rago emphasized that fighting counterfeits requires the joint efforts of MRA, industry, law enforcement agencies, national regional and global cooperation. An initiative being considered is the establishment of an international convention on counterfeit medicines control along similar lines of those controlling narcotic and psychotropic substances.

Vaccine regulation and monitoring of clinical trials vaccines

(Mrs. Lilana Chocarro, IVB/WHO)

Mrs Lilana Chocarro, IVB/WHO gave a presentation on the regulatory issues for vaccines and clinical trials evaluation. She emphasized the need to sensitize MRAs on the need to regulate the manufacturing and registration of vaccines, conduct post-marketing surveillance of vaccines including recording Adverse Reactions Following Immunization (ARFI) and clinical trials. She reviewed the procedures for evaluation of vaccines and the progress WHO has made in strengthening the regulatory capacity for vaccines in Africa.

Mrs Choccaro informed the participants of the availability of tools and support to countries to improve vaccines regulation including vaccine clinical trials. These include training activities available through the Global Training Network (GTN) and support to develop institutional development plans that can be used for advocacy and resource mobilization for vaccine regulatory activities.

WHO pre-qualification of priority medicines

(Dr Lembit Rago)

Dr Lembit Rago presented an overview of the WHO pre-qualification project including a demonstration on how to access information from the project web

4.10 Current topics


site. He took the participants through the information on pre-qualified products, manufacturers, assessment and inspection reports, and training modules on GMP. This information is all available on the web site.

He advised countries—especially resource-poor MRAs which can consult the lists of pre-qualified medicines for priority diseases—to make use of this information in making their regulatory decisions.

Group work on regulatory gaps of MRAs in sub-Saharan Africa and the development of a five-year regional plan with identified priority activities to promote effective medicines regulation.

Dr Jean-Marie Trapsida then presented the results of an assessment of the medicines regulatory gaps that were identified from a WHO study of six MRAs in the African Region: Ethiopia, Ghana, Mali, Nigeria, Senegal and Tanzania. The purpose of the assessment was to review the existing legal framework as well as the regulatory and control systems. The assessments were carried out in collaboration with national authorities to identify gaps, make recommendations and develop a plan of action on how to address the gaps.

He outlined the methodology used in the assessment, which included a data collection tool that was completed by the MRAs. The assessment team, comprising WHO/HQ, AFRO and an independent consultant reviewed and discussed the information provided with the staff of the MRA as well as with pharmaceutical manufacturers and importers and other stakeholders.

The major gaps identified were an inadequate legal framework for medicines regulation, inadequate MRA structure, staff and office resources such as computers, vehicles, inadequate and non-sustainable financing of medicine regulation activities, weak infrastructure, lack of access to independent and objective information, and lack of management capacity. The lack of cooperation with other law enforcement agencies and no consultation with stakeholders, professional associations, consumer associations, industries and importers were also found to be major problems with the MRAs in the six countries.

The two working groups then presented the results of their group work on the review of medicines regulatory gaps in sub-Saharan Africa. The results are given in the following table.

4. http://mednet3.who.int/prequal/


Str

en

gth

s an

d o

pp

ort

un

itie

sW

eakn

ess

es

Barr

iers

Str

ate

gie

s to

im

pro

ve r

egu

lati

on

•La

ck o

f/an

d i

nad

eq

uat

e l

egi

slat

ion,

regu

lations,

gu

idelin

es,

SO

Ps

for

all

med

icin

e re

gula

tory

funct

ions.

•In

adeq

uat

e sta

tus/

stru

ctu

re o

f the M

RA

.

•In

adeq

uat

e n

um

bers

of s

kille

d sta

ff.

•In

adeq

uat

e r

eso

urc

es

and

logi

stic

s: c

om

pu

ters

, finan

ces,

sto

rage

sp

ace f

or

doss

iers

and

sam

ple

s, v

ehic

les.

•In

adeq

uat

e

inst

itu

tional

lin

k ag

es

betw

een

the

diffe

rent

regu

lato

ry

funct

ions.

•La

ck o

f ad

eq

uat

e p

riori

tiza

tion/r

isk-

bas

ed

ap

pro

ach.

•La

ck o

f cod

e o

f cond

uct

and

tran

spar

ency

sys

tem

s.

•La

ck o

f coop

era

tion b

etw

een sta

kehold

ers

.

•In

adeq

uat

e e

nfo

rcem

ent m

ech

anis

m a

nd

san

ctio

ns.

•In

adeq

uat

e sensi

tiza

tion o

f the p

ub

lic a

nd

oth

er s

take

hold

ers

.

•In

adeq

uat

e g

uid

elin

es fo

r phar

mac

ovi

gila

nce

.

•In

adeq

uat

e a

pp

reci

atio

n o

f im

port

ance

of e

ffect

ive m

ed

icin

e re

gula

tion.

•Ta

ke g

rad

ual

, feas

ible

and

real

istic

step

s to

war

ds re

gula

tion.

•R

evi

ew

and

str

engt

hen le

gisl

atio

n.

•Pu

t in p

lace

an a

pp

rop

riat

e str

uct

ure

to su

pp

ort

eff

ect

ive re

gula

tion.

•R

evi

ew

and

deve

lop

/str

engt

hen r

egu

lations,

gu

idelin

es

and

pro

ced

ure

s to

sup

port

regu

lation.

•Es

tab

lish m

ech

anis

ms to

ensu

re fi

nan

cial

su

stai

nab

ility

of M

RA

s.

•Se

t u

p a

mech

anis

m t

o e

nsu

re r

ecr

uitm

ent,

tra

inin

g an

d m

ainte

nan

ce o

f

adeq

uat

e h

um

an re

sou

rce (n

um

bers

and

ski

lls).

•Pu

t in p

lace

ad

voca

cy str

ategi

es fo

r eff

ect

ive d

rug

regu

lation.

•Im

pro

ve I

EC/s

ensi

tiza

tion o

f st

akehold

ers

/pu

blic

/civ

il so

cieties

to a

pp

reci

ate

and

su

pp

ort

eff

ect

ive d

rug

regu

lation.

•Se

t up

sys

tem

s fo

r man

agin

g an

d m

ech

anis

m fo

r shar

ing

info

rmat

ion.

•Pu

t in

pla

ce m

ech

anis

ms

for

monitori

ng

and

eva

luat

ion o

f im

ple

menta

tion o

f

dru

g re

gula

tion.

•Ex

iste

nce

of s

om

e le

gisl

atio

n fo

r regu

lation.

•Ex

iste

nce

of s

om

e re

gula

tory

str

uct

ure

s of v

ario

us st

rengt

hs.

•Ex

iste

nce

of s

om

e sta

ff to

perf

orm

som

e re

gula

tory

funct

ions.

•Ex

iste

nce

of

refe

rence

s an

d n

orm

s fr

om

WH

O (

op

port

unity)

Exi

stence

of

har

moniz

atio

n

initia

tive

s an

d

incr

eas

ing

coop

era

tion

betw

een

som

e

cou

ntr

ies.

•In

eff

ect

ive li

censi

ng

of p

rem

ises an

d a

ctiv

itie

s.

•In

adeq

uat

e m

arke

t contr

ol.

•U

nre

gist

ere

d p

rod

uct

s on th

e m

arke

t.

•La

ck o

f tra

nsp

arency

in re

gist

ration sys

tem

s/p

ract

ices.

•In

adeq

uat

e a

ccess

to Q

C L

abs to

su

pp

ort

regi

stra

tion.

•Poor i

nsp

ect

ion p

ract

ices.

•Poor c

od

e o

f cond

uct

– c

orr

up

tion.

•D

up

licat

ion a

nd

conflic

t betw

een sta

kehold

ers

..

•U

neth

ical

pro

motion p

ract

ices.

•B

iase

d/inac

cura

te in

form

atio

n to

the p

ub

lic a

nd

heal

th w

ork

ers

.

•U

nre

gula

ted

clin

ical

tri

als

and

poor

coord

inat

ion a

mong

inst

itu

tions

invo

lved

in re

gula

tion o

f clin

ical

tria

ls.

•N

on-e

xist

ence

/weak

PM

S/p

har

mac

ovi

gila

nce

sys

tem

s.

•La

ck

of/

and

in

adeq

uat

e

com

mu

nic

atio

n

stra

tegy

to

su

pp

ort

eff

ect

ive

regu

lation a

nd

behav

ior c

han

ge.

•W

eak

str

uct

ure

s/st

atu

s of M

RA

in th

e G

ove

rnm

ent.

26

Firs

t A

fric

an M

edic

ines

Reg

ulat

ory

Aut

hori

ties

Con

fere

nce

Fina

l Rep

ort

The g

rou

ps

also

id

entified

the r

ole

s fo

r eac

h p

artn

er

in a

dd

ress

ing

the a

bove

-mentioned

regu

lato

ry g

aps:

§P

ut

in

pla

ce

a

pp

rop

ria

te

legi

slat

ion.

§Se

t u

p an

d su

pp

ort

ap

pro

pri

ate

stru

ctu

re o

f MR

A.

§Es

tab

lish a

nd

su

pp

ort

su

stai

nab

le

fin

anci

ng

mech

anis

ms

for

the

MR

As.

§Sp

ear

head

p

olit

ical

su

pp

ort

fo

r d

rug

regu

lation.

§Su

pp

ort

har

moniz

atio

n a

nd

pu

t in

p

lace

a

cond

uci

ve

envi

ronm

ent

for h

arm

oniz

atio

n.

§Pu

t in

p

lace

m

ech

anis

ms

for

monitori

ng

and

eva

luat

ion.

Go

vern

men

t

§In

itia

te p

roce

ss fo

r re

view

ing

and

st

rengt

henin

g le

gisl

atio

n w

ith h

elp

of M

OH

and

par

liam

ent.

§P

rop

ose

to

go

ve

rnm

en

t/M

OH

ap

pro

pri

ate str

uct

ure

s fo

r the M

RA

.

§R

evi

ew

and

cre

ate r

eal

istic

stra

tegi

c p

lans.

§R

evie

w/s

tre

ngth

en

re

gu

lati

on

s,

guid

elin

es,

SO

Ps.

§Pu

t in

m

ech

anis

ms

for

finan

cial

su

stai

nab

ility

.

§P

re

pa

re

h

um

an

re

so

urc

e

deve

lop

men

t p

oli

cy

an

d

pla

n

(recr

uitm

en

t,

trai

nin

g,

rete

ntio

n,

rem

unera

tion).

§IE

C/a

dvo

cacy

fo

r ap

pre

ciat

ion

of

and

su

pp

ort

for d

rug

regu

lation.

§W

ork

to

war

ds

har

moniz

atio

n

of

regu

lation.

MR

As

§Su

pp

ort

deve

lop

ment o

f ap

pro

pri

ate

legi

slat

ion a

nd

MR

A str

uct

ure

.

§Su

pp

ort

deve

lop

ment of re

gula

tions,

gu

idelin

es,

SO

Ps.

§Su

pp

ort

trai

nin

g of M

RA

sta

ff.

§A

dvo

cate

fo

r ad

eq

uat

e

finan

cing

mech

anis

ms fo

r MR

As.

§Su

pp

ort

MR

As/

cou

ntr

ies

in r

eso

urc

e

mob

iliza

tion m

ech

anis

m t

o s

up

port

m

ed

icin

e re

gula

tion.

§P

rovi

de

tech

nic

al

ass

ista

nce

to

fa

cilit

ate s

trengt

henin

g of

med

icin

e

regu

lation.

§Su

pp

ort

mech

anis

ms fo

r exc

han

ge o

f in

form

ati

on

b

etw

een

co

un

trie

s:

web

site

, e-m

ail, a

nd

meetings

.

§Su

pp

ort

re

gio

nal

harm

on

izati

on

in

itia

tive

s.

Go

vern

men

t

27

Firs

t A

fric

an M

edic

ines

Reg

ulat

ory

Aut

hori

ties

Con

fere

nce

Fina

l Rep

ort

5. DEVELOPMENT OF THE REGIONAL STRATEGIC PLAN

The main objective of the conference was to prepare a five-year regional strategic plan. It was recommended that the two-year national plans be finalized later and submitted by each Medicines Regulatory Authority (MRA).

Mr Eshetu Wondemagegnehu presented an overview of the WHO MRA evaluation tool. The tool collects information in six parts as follows:

(a) the general information on the country and MRA,

(b) organization of the MRA,

(c) the legislation and regulatory system,

(d) human resources management,

(e) strategic plan for institutional development and

(f) other regulatory functions.

Dr Jean-Marie Trapsida then introduced the participants to the group work for the development of the regional strategic plan 2006–2010. Participants were also requested to identify priority activities to be undertaken during this period.

The workplans developed by two groups were presented and discussed in a plenary session. The participants thereafter adopted one consolidated plan with priority activities as shown in the following table:


REG

ION

AL

PLA

N T

O P

RO

MO

TE M

ED

CIN

ES R

EG

ULA

TIO

N I

N W

HO

/AFR

O R

EG

ION

(2

00

6–2

01

0)

Pro

ble

m t

o b

e a

dd

ress

ed

O

bje

ctiv

e

Main

str

ategy/

ap

pro

ach

M

ain

act

ivit

y (i

es)

-WH

O/A

FRO

Inap

pro

pri

ate

lega

l st

atus

of

nat

ional

m

ed

icin

e

regu

lato

ry

auth

ori

ties

to

carr

y ou

t th

eir

re

gula

tory

fu

nct

ions.

To

mak

e

nat

ional

m

ed

icin

e

regu

lato

ry

auth

ori

ties

auto

nom

ous.

Esta

blis

h a

uto

nom

ou

s m

ed

icin

es

regu

lato

ry a

uth

ori

ties

as a

sin

gle

stru

cture

fo

r im

pro

ved

p

erf

orm

ance

.

Ass

ist

countr

ies

in s

ubm

itting

a p

rop

osa

l to

nat

ional

go

vern

ments

for

the c

reat

ion o

f au

tonom

ous

NM

RA

.

Ass

ist

in th

e

pre

par

atio

n d

ocu

ments

th

at p

rovi

de

auto

nom

y to

the N

MR

A.

Pro

vid

e a

ssis

tance

to N

MR

A t

o m

ake t

he r

egu

lato

ry

funct

ion e

ffect

ive.

Sup

port

in initia

ting

con

sultat

ive c

om

mis

sions.

Inad

eq

uat

e

hum

an

reso

urc

es.

To

d

eve

lop

th

e

cap

acity

of

hum

an

reso

urc

es.

Trai

nin

g of

MR

A s

taff.

P

rom

otion

of

exc

han

ge

of

exp

ert

ise b

etw

een c

ountr

ies

and

p

oolin

g of

exp

ert

ise in t

he R

egi

on.

U

se

tech

nic

al

assi

stan

ce

from

outs

ide t

he R

egi

on.

Pro

vid

e t

rain

ing

in:

- p

rod

uct

regi

stra

tion.

- in

spect

ion-G

MP.

- q

ual

ity

contr

ol.

- p

har

mac

ovi

gila

nce

.

- co

ntr

ol of

clin

ical

tri

als.

- G

CP.

- m

anag

em

ent

(of

MR

As)

.

- eff

ect

ive c

om

munic

atio

n.

Cre

ate d

atab

ase o

n e

xpert

ise w

ithin

the R

egi

on.

SWO

T a

nal

ysis

for

hum

an r

eso

urc

es.

Org

aniz

e t

rain

ing

of

trai

ners

(T

OT).

Org

aniz

e d

iscu

ssio

n f

ora

.

Arr

ange

exc

han

ge o

f w

ork

ing

visi

ts.

Identify

tech

nic

al a

ssis

tance

with a

goal

to d

eve

lop

nat

ional

cap

acity.

Inad

eq

uat

e l

egis

lation a

nd

re

gula

tions.

To d

eve

lop

, re

vise

and

up

dat

e

legi

slat

ion/

regu

lations.

Ad

voca

cy

for

com

pre

hensi

ve,

stro

ng

legi

slat

ion a

nd

regu

lations.

Cond

uct

ass

ess

ment

of

legi

slat

ion.

Pro

vid

e m

od

el le

gisl

atio

n.

Pro

vid

e

tech

nic

al

and

finan

cial

su

pp

ort

to

d

eve

lop

/revi

se/u

pd

ate legi

slat

ion a

nd

regu

lations.

29

Firs

t A

fric

an M

edic

ines

Reg

ulat

ory

Aut

hori

ties

Con

fere

nce

Fina

l Rep

ort

30

Firs

t A

fric

an M

edic

ines

Reg

ulat

ory

Aut

hori

ties

Con

fere

nce

Fina

l Rep

ort

Weak

in

form

atio

n

man

agem

ent

syst

em

an

d

lack

of

acce

ss

to

ind

ep

end

ent

info

rmat

ion.

To

build

in

form

atio

n

man

agem

ent

and

exc

han

ge s

yste

m.

To

imp

rove

ac

cess

to

in

dep

end

ent

info

rmat

ion.

Str

engt

hen

sy

stem

s fo

r in

form

atio

n

man

agem

ent

and

exc

han

ge.

Cre

ate a

ccess

to I

nte

rnet.

Cre

ate

an

info

rmat

ion

dat

abas

e:

Regi

onal

sh

ared

p

oin

ts.

Sup

port

exc

han

ge o

f in

form

atio

n w

ithin

the r

egi

on.

Deve

lop

mod

el so

ftw

are a

nd

websi

te d

esi

gn.

Sup

port

countr

ies

to h

ave w

ebsi

te,

dat

abas

es

and

IT

syst

em

s/har

dw

are.

Trai

n c

ountr

ies

in info

rmat

ion m

anag

em

ent.

Deve

lop

to

ols

fo

r IE

C

and

behav

iour

chan

ge

for

eff

ect

ive d

rug

regu

lation.

Inad

eq

uat

e

tools

—gu

idelin

es,

p

roce

dure

s,

SO

Ps

not

fully

deve

lop

ed

.

To re

view

, re

vise

an

d

deve

lop

tools

.

To

tran

slat

e

WH

O

tools

into

oth

er

WH

O

langu

ages

and

d

istr

ibute

th

em

to

co

untr

ies.

Pro

vid

e

tech

nic

al

assi

stan

ce

to

deve

lop

tools

.

Pro

vid

e m

od

el

tools

to c

ou

ntr

ies

to a

dop

t or

adap

t th

em

.

Identify

ess

ential

tools

for

good

regu

lato

ry p

ract

ice.

Faci

litat

e

deve

lop

ment,

ad

op

tion,

adap

tation

and

im

ple

menta

tio

n

of

mod

el/har

moniz

ed

to

ols

(b

est

p

ract

ices

within

the R

egi

on).

Tran

slat

e e

xist

ing

tool in

to o

ther

WH

O lan

guag

es.

Lac

k of

tech

nic

al

coop

era

tion

netw

ork

ing

betw

een M

RA

s.

To

est

ablis

h

and

st

rengt

hen

regi

onal

an

d

subre

gional

har

moniz

atio

n

and

netw

ork

ing.

To c

reat

e a

regi

onal

d

iscu

ssio

n f

oru

m.

Su

pp

ort

regi

onal

and

su

bre

gional

har

moniz

atio

n initia

tive

s.

Ad

voca

te

for

har

moniz

atio

n

at

the r

egi

onal

eco

nom

ic b

locs

.

Cre

ate a

nd

sup

port

dis

cuss

ion f

ora

.

Fost

er

har

moniz

atio

n b

y usi

ng

WH

O i

nte

r-re

gional

st

ruct

ure

s an

d r

egi

onal

blo

cs.

Inad

eq

uat

e f

und

ing

To

cr

eat

e

adeq

uat

e

and

su

stai

nab

le

fund

ing

syst

em

fo

r M

RA

s.

Enco

ura

ge/a

dvo

cate

str

ategi

es

for

sust

ainab

le f

und

ing.

Ensu

re

that

th

ere

is

fu

nd

ing

ded

icat

ed

to

med

icin

es

regu

lation/M

RA

s.

Deve

lop

pro

ject

s to

mobili

ze f

und

ing.

Ad

voca

te

for

ded

icat

ed

fu

nd

ing

from

re

gional

eco

nom

ic b

locs

for

med

icin

es

regu

lation.

Ad

vise

countr

ies

on m

ech

anis

ms

to g

enera

te f

und

ing

for

MR

As.

Pro

ble

m t

o b

e a

dd

ress

ed

O

bje

ctiv

e

Main

str

ate

gy/

ap

pro

ach

M

ain

act

ivit

y (i

es)

-WH

O/A

FR

O

Inad

eq

uat

e

imp

ort

an

d

exp

ort

contr

ols

.To

st

rengt

hen

imp

ort

an

d e

xport

contr

ols

.P

rom

ote

/su

pport

co

op

era

tion

and

co

ord

inat

ion

betw

een

countr

ies,

MR

As,

Cu

stom

s, o

ther

agenci

es.

Faci

litat

e a

foru

m fo

r d

iscu

ssio

n betw

een re

leva

nt

agenci

es.

Pro

vid

e m

od

el ce

rtific

atio

n s

yste

ms.

Sup

port

rele

vant

trai

nin

g in

contr

olli

ng

imp

ort

and

exp

ort

of

med

icin

es.

Stre

ngt

hen

legi

slat

ion

and

re

gula

tions

to

faci

litat

e

eff

ect

ive c

ontr

ol of

imp

ort

and

exp

ort

of m

ed

icin

es.

Weak

mar

ket

contr

ol.

To

stre

ngt

hen

mar

ket

contr

ol.

Deve

lop

st

rate

gies

for

enfo

rcem

ent

of

good

dis

trib

ution

pra

ctic

es

(GD

P)

and

m

arke

t co

ntr

ol.

Stre

ngt

hen

p

ost

-mar

keting

surv

eill

ance

bas

ed

on

risk

m

anag

em

ent.

Ad

voca

te f

or

GD

P a

nd

hig

hlig

ht

dan

gers

of

poor

mar

ket

contr

ols

an

d p

ract

ices.

Help

countr

ies

imp

lem

ent

and

enfo

rce G

DP.

Pro

vid

e

sup

port

fo

r in

nova

tive

an

d

alte

rnat

ive

dis

trib

ution

syst

em

s w

ithout

loosi

ng

sigh

t of

stre

ngt

hen

ing

conve

ntional

sys

tem

s.

Sup

port

com

munity

mobili

zation a

ctiv

itie

s to

sup

port

eff

ect

ive m

arke

t co

ntr

ols

.

Exis

tence

of

cou

nte

rfeit

pro

du

cts

on

nat

ional

m

arke

ts.

To

creat

e

eff

ect

ive

syst

em

s fo

r co

mbat

ing

counte

rfeit m

ed

icin

es.

Ad

voca

te

and

su

pp

ort

st

rate

gies

for

com

bat

ing

counte

rfeit

med

icin

es.

Trai

nin

g in

d

ete

ctio

n

and

id

entifica

tion

of

counte

rfeit

med

icin

es.

Cre

ate R

apid

Ale

rt S

yste

m (

RA

S)

for

exc

han

ge o

f in

form

atio

n.

Put

in p

lace

a s

yste

m f

or

dete

ctio

n a

nd

shar

ing

of

info

rmat

ion o

n c

ounte

rfeit m

ed

icin

es.

Sup

port

th

e p

artici

pat

ion

of

countr

ies

in

inte

rnat

ional

meetings

.

Sup

port

the p

oss

ibili

ty o

f est

ablis

hin

g a

conve

ntion

on c

ounte

rfeit m

ed

icin

es.

31

Firs

t A

fric

an M

edic

ines

Reg

ulat

ory

Aut

hori

ties

Con

fere

nce

Fina

l Rep

ort

Pro

ble

m t

o b

e a

dd

ress

ed

O

bje

ctiv

e

Main

str

ategy/

ap

pro

ach

M

ain

act

ivit

y (i

es)

-WH

O/A

FRO

Loca

l p

rod

uct

ion

firm

s non-c

om

plia

nt

with G

MP

(A

RV

s,

anti-m

alar

ial

and

an

ti-T

B m

ed

icin

es)

.

To

enhan

ce

GM

P

com

plia

nce

by

loca

l m

anufa

cture

rs.

Pro

vid

e

tech

nic

al

assi

stan

ce

to

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Trai

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and

m

onitori

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32

Firs

t A

fric

an M

edic

ines

Reg

ulat

ory

Aut

hori

ties

Con

fere

nce

Fina

l Rep

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Pro

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m t

o b

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dd

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O

bje

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Main

str

ategy/

ap

pro

ach

M

ain

act

ivit

y (i

es)

-WH

O/A

FRO

6. RECOMMENDATIONS

Based on the various discussions during the meeting, the following recommendations were made:

Recommendations to MRAs

§Develop and implement strategies to promote effective medicines regulation.

§Prepare and submit to WHO/AFRO a two-year national plan indicating the priority activities to be undertaken in 2006–2007 to improve medicines regulation.

§Explore regional collaboration and support the creation of networks to share information on medicines regulation.

Recommendations to governments

§Support medicines regulation and provide adequate funds to MRAs to perform their functions.

§Advocate for and support subregional and regional harmonization initiatives.

§Support human resources development for medicines regulation.

§Institutionalize the development and strengthening of autonomous MRAs.

Recommendations to WHO

§To further the exchange of information and experiences of medicines regulation in the region, it was recommended that WHO/AFRO organize a conference for all African Medicines Regulatory Authorities at least once every two years.

§Ensure better coordination of medicines regulatory activities in the region.

§Advocate for countries to establish MRAs and adequately fund medicines regulation.

§Strengthen and expand MRA assessments to other countries in the region.

§Support capacity building and training of MRA staff.

§Ensure that all existing tools and documents are available in both English and French.

§Promote the exchange and use of technical expertise available in the region.


7. CLOSING CEREMONY

The conference was officially closed by Mrs Malebona Matsoso, Director of the Department of Technical Cooperation for Essential Drugs and Traditional Medicines, WHO (TCM/WHO). In her closing remarks, Mrs Matsoso thanked and congratulated the participants for a successful meeting, especially the conference chairpersons and rapporteurs for the excellent work done. She noted with satisfaction that the objectives of the conference had been achieved and hoped that this was the beginning of the process to strengthen medicines regulation in the region.

Mrs Matsoso appreciated the enriching discussions and experiences that were shared by participants during the course of the meeting and was confident that these lessons would be taken back home to improve medicines regulation in their respective countries.

She reiterated WHO's commitment and unwavering support to improve medicines regulation in the countries and continued advocacy. She informed participants that WHO would be celebrating 30 years of the Essential Medicines Concept in 2007. Her department intends to use the occasion to profile the exceptional work that has so far been done in this field through improving access to essential medicines, and medicines regulation.

Mrs Matsoso thanked the participants once again for the work accomplished during the conference and wished them a safe journey home. After these remarks, the meeting was declared officially closed.

Speaking earlier, the conference co-chair, Dr Maiga Minkaila thanked WHO for organizing the conference, and the Government of Ethiopia for hosting it. He noted with appreciation the enormous work that was accomplished during the four-day duration and was confident that when the recommendations are implemented, they will go a long way in improving the situation of medicines regulation in the region. On behalf of the conference chairs and the participants, he thanked the rapporteurs and interpreters for their admirable work.

Dr Safiatou Ouattara offered a vote of thanks to the conference hosts, organizers, and participants.


ANGOLAMr Daniel AntonioTel: +244-222-320030Fax: + 244-222-328166e-mail: [email protected]

BENINDansou AlfredTel: +229-90903298Fax: +229-330882e-mail: [email protected]

BOTSWANADr Sinah SeleloTel: +267-3-632064Fax: +267-3-180870e-mail: [email protected]

BURKINA FASODr Amadou KoumareTel: +226-50324660 / 70250915Fax: -+226-50314476e-mail: akoumare2002 @yahoo.fr

Dr. Ouattara SafiatouTel: +226-50324660Fax: +226-50314476e-mail: [email protected]

CAMEROONDr Ngono Mballa RoseTel: +237-221-0259Fax: +237-221-1077e-mail: [email protected]

OCEACDr Peyou Ndi MarlyseTel: +237-616-4932Fax: +237-223-0061e-mail: [email protected]

CHADDr Ahmat Ali HisseinTel: +235-517566Fax: +235-517566e-mail: [email protected] or [email protected]

COMOROSDr Said Omar Said HamidouTel: +269-731-264 / 269-330-480Fax: +269-731-724e-mail: [email protected]

REPUBLIC OF CONGODr Gondzia Guy PatrickTel: +242-810-542 / 662-3525Fax: +242-810-543e-mail: [email protected]

CÔTE D'IVOIREDr Rosalie Assi GbononTel: +225-213-57313Fax: +225-213-56958e-mail: [email protected]

EQUATORIAL GUINEAMr Mocong Mate RafaelTel: +240-2-51305e-mail: [email protected]

ETHIOPIAMr Abraham G. Giorgis KahsayTel: + 251-115-524116Fax: +251-111-5521392e-mail: [email protected]

GAMBIAMrs Fatoumata I.N JahTel: +220-4-225374Fax: +220-4-225873e-mail: [email protected]

ANNEX: LIST OF PARTICIPANTS


GHANAMr E. Kyeremateng AgyarkoTel: +233-2-1660489Fax: +233-2-1660389e-mail: [email protected]

Mr Benjamin Kwame BotweTel: +233-2-1910760Fax: +233-2-1660389e-mail: [email protected]

GUINEADr Bah HarirataTel: +244-4-52028 / 297071Fax: +224-4-52050e-mail: [email protected]

GUINEA-BISSAUMr Pepas Vincente NatakTel: +245-7-206617Fax: +245-7-201188e-mail: [email protected]

KENYAMs Sarah Akoth ChuchuTel: +254-227-21937Fax: [email protected]

MADAGASCARDr Rasoanaivo Nivo HanitraTel: [email protected]

MALAWIDr Wynn Charles ChaliraTel: + 265-1-752652Fax: +265-1-755204e-mail: [email protected]

MALIDr Maiga Minkaila D.Tel: +223-222-6570Fax: +233-223-2463e-mail: [email protected]

MOZAMBIQUEDr Suraia Mussa NanlaTel:+258-21-326547Fax: +258-21-303473e-mail: [email protected]

Dr Tania Vuyeya SitoiTel:+258-213-26547Fax: +258-213-03473e-mail: [email protected]

NAMIBIAMs. Dinah Jorokee TjihoTel: +264-61-2032391Fax: +264-61-234462e-mail: [email protected] or [email protected]

NIGERElhadj Maty MamanTel: +227-722450Fax: +227-733570e-mail: [email protected]

NIGERIAMr Hashim Ubale YusufuTel: +234-9-6709894Fax: +234-9-5241106e-mail: [email protected]

RWANDAMr Munyankinde VedasteTel: +250-5-11270e-mail: [email protected]

SAO TOME AND PRINCIPEDr Marcelina Quaresma J. CostaTel: +239-225942Fax: +239-221306e-mail: [email protected]

SENEGALDr Ngom MamadouTel: +221-8695937Fax: +221-8204314e-mail: [email protected]


SEYCHELLESMrs Aimie TotinTel: +248-388333Fax: +248-323618e-mail: [email protected]

SIERRA LEONEMr Michael Jack LansanaTel: +232-22-229346 / 228497Fax: +232-22-224526e-mail: [email protected] or [email protected]

TANZANIAMr Hiiti Baran SilloTel: +255-744-307179Fax: +255-222-450793e-mail: [email protected]; [email protected]

Ms. Margareth Ndomondo SigondaTel: +255-22-2450 979Fax: +255-22-2450793e-mail: [email protected] or [email protected]

Dr. Nditonda Benno ChukilizoTel: +255-22-2450512Fax: +255-22-2450793e-mail: [email protected] or [email protected]

Ms. Rose ShijaTel: +255-22-2111718Fax: +255-22-2113180e-mail: [email protected]

TOGODr Atany Nyansa (Bernardin)Tel: +228-22-20799 / +228-09-206221Fax:+228-22-20799e-mail: [email protected]

UGANDAMr Apollo MuhairweTel: +256-41-255665Fax: +256-41-255758e-mail: [email protected]

Mr Deusdedit MubangiziTel: +256-41-347391 / 2Fax: [email protected]

Mr Joseph SerutokeTel: +256-41-335500Fax: +256-41-335569e-mail: [email protected]

ZAMBIAMr Felix Peter ChizuTel: +261-1-220429Fax: +261-1-238458e-mail: [email protected]

ZIMBABWEMs Gugu Nolwandle MahlanguTel: +263-4-736981 / 5Fax: +263-4-736980e-mail: [email protected]

Mr Mafios DauramanziTel: +263-736981–5Fax: +263-4-736980e-mail: [email protected]

WHO SECRETARIATMrs. Malebona MatsosoTCM/WHOTel: +41-22-791-1452e-mail: [email protected]

Dr. Lembit RagoQSM/PSMTel: +41-22-791-4420Fax: 41-22-791-4730e-mail: [email protected]

Mrs. Lilana ChocarroIVB/ WHOTel: +41-22-791-1883Fax: [email protected]


Mr. Eshetu WondemagegnehuQSM/PSMTel: +41-22-791-3473Fax: +41-22-791-4730e-mail: [email protected]

Mr Tefera BekeleNPO/WCO, EthiopiaTel: +251-115-44-44-53e-mail: [email protected]

Dr Modibo DickoWHO/AFROTel: +47-241-38200 / +263-11412488e-mail: [email protected]

Dr Jean-Marie TrapsidaEDM/AFROTel: +47 241 39258Fax: +47 241 39511e-mail: [email protected]


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