edqm brochure updated june 2010

Since 1964 at the service of quality ofEUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINES & HEALTHCARESince 1964 at the service of quality of medicines in Europe

European Directorate for theQuality of Medicines & HealthCare

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2 | ||| | | | EDQM: SINCE 1964 AT THE SERVICE OF QUALITY OF MEDICINES IN EUROPE

*Summary

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CHAPTER 1 THE EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINES & HEALTHCARE (EDQM) page 5

CHAPTER 2 THE EUROPEAN PHARMACOPOEIA IN BRIEF page 8

CHAPTER 3 HOW THE EUROPEAN PHARMACOPOEIA WORKS page 10

CHAPTER 4 HOW THE EUROPEAN PHARMACOPOEIA HAS ADAPTED TO GLOBALISATION OF TRADE IN MEDICINAL PRODUCTS: THE CERTIFICATION PROCEDURE page 13

CHAPTER 5 THE EUROPEAN PHARMACOPOEIA AND THE INTERNATIONAL HARMONISATION PROCESS WITH THE UNITED STATES AND JAPAN page 14


ForewordFirst of all, tribute should be paid to the signatory states that have decided to work

towards the unification of standards and to the members of the European

Pharmacopoeia Commission and of the groups of experts, to the network of national

control laboratories, to the experts in blood transfusion and organ transplantation,

who have made this undertaking successful by volunteering their expertise. The

dedication and enthusiasm of all those who have contributed to the elaboration of

the European Pharmacopoeia, who have participated to the development of the

coordinated activities in the control of medicines (Official Medicines Control

Laboratories) and in activities in the fields of blood transfusion, organ transplantation,

pharmaceutical care, cosmetics and food packaging should be applauded.

THE EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINES & HEALTHCARE

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*International Organisation for Standardisation

The EDQM building

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate of the Council of Europe located in Strasbourg. From a simple tablet taken with a glass of water to the most complex types of treatments, all medicines produced and sold in Europe must comply with strict specifications on their composition, manufacturing processes and quality. Under the aegis of the Council of Europe, the EDQM plays a central role in the regulation of medicines, not only for countries of the Council of Europe but also those of the European Union. In addition, it is vital in the establishment of standards and best practices in the area of health and pharmaceutical care.

The EDQM is in charge of all activities related to the elaboration of a European Pharmacopoeia (see chapters 2, 3 and 5)The objectives of the European Pharmacopoeia are to set quality standards for medicines to ensure public health in Europe, to respond rapidly to new risks to public health (e.g.: mad cow disease, counterfeit medicines, etc.) by elaborating new methods of analysis and tests and to facilitate the free movement and trade of medicines among as many countries as possible.

In this context, the EDQM is in charge of:• drafting and publishing monographs and other pharmacopoeial

texts (printed, offline and online versions) and distributing the European Pharmacopoeia and other publications;

• checking the analytical methods described in the monographs experimentally in the laboratory; the laboratory also carries out analytical studies and organises collaborative studies to establish European Pharmacopoeia reference standards or preparations;

• preparing, managing and dispatching European Pharmacopoeia reference standards;

• establishing and validating alternative methods for European Pharmacopoeia tests requiring the use of animals;

• organising regularly congresses on new scientific and technical subjects, as well as seminars and training sessions on subjects related to the European Pharmacopoeia.

Since 1998, the EDQM has continuously developed its internet websites to offer users of the European Pharmacopoeia additional technical and scientific support.

The EDQM staff consists of: pharmacists, chemists, biochemists, biologists, technicians, specialised secretaries, computer engineers and programmers, specialised translators, statisticians and archivists, of about 19 different nationalities.

The EDQM is responsible for the certification of suitability to monographs of the European Pharmacopoeia (see chapter 4)The procedure for Certification of suitability (CEP) complements the EDQM’s activities in the domain of the European Pharmacopoeia. The role of a Certificate of suitability is to certify the capability of the relevant monograph(s) of the European Pharmacopoeia to adequately control the quality of a given substance from a given source. It provides for a centralised assessment of the quality documentation for substances used in the production of medicines that facilitates handling of marketing authorisation applications for regulatory authorities, the substance manufacturer and the marketing authorisation applicant. Active pharmaceutical ingredients for which a Certificate of suitability has been granted and which meet the requirements laid down in the Certificate are suitable for use in medicinal products.This Certification scheme also provides the European Pharmacopoeia with information on the real quality of substances

on the market and assists it to carry out necessary revisions to monographs. It hence contributes to the evaluation and control of medicines prior to their marketing.In the framework of the scheme, on-site inspections of sites covered by a Certificate of suitability are conducted to check compliance with the application (and any updates) with Good Manufacturing Practice (GMP), following a risk-based selection of sites to be inspected.

The pharmaceutical legislation in the European Union (EU) mentions the use of Certificates of suitability to the monographs of the European Pharmacopoeia as one option to demonstrate in marketing authorisation applications that the substances being used by the manufacturers comply with specifications. In addition, Certificates of suitability are recognized and accepted by the regulatory authorities of a number of other countries, e.g. Canada.

The EDQM provides administrative co-ordination and a secretariat for this procedure; more than 80 national experts participate as assessors and rapporteurs in the evaluations of the dossiers received (around 400 new dossiers per year); around 20 GMP inspectors from member states of the European Pharmacopoeia Convention participated in the inspections (around 35 inspections per year).

In 2009, the EDQM received ISO* 9001:2008 certification for its Certification of suitability scheme, covering both assessment and inspections. The certification was awarded by the official French standardisation body Association française de normalisation (Afnor) via Afnor Certification (AFAQ).

The EDQM is also responsible for a number of activities, in collaboration with the EU, related to SURvEILLANCE OF PHARMACEUTICAL PRODUCTS marketed and distributed in EuropeAs part of its surveillance activities for marketed medicines, the EDQM co-ordinates the European Network of Official Medicines Control Laboratories (OMCL); this activity was set up in 1995 at the request of the European Union.


Organisational chartAbout 70 Official Medicines Control Laboratories in 40 countries collaborate in the General European OMCL network, which is comprised of the 27 EU member states and the member states of the European Pharmacopoeia Convention. This activity is essential in Europe to facilitate mutual recognition of quality control tests carried out on medicines and ensures that patients receive the same quality of pharmaceutical products throughout Europe.The EDQM organises general market surveillance studies on products marketed throughout Europe. For example, the analysis of the quality of antibiotic granules and powders, herbal preparations.

Within the restricted EU OMCL-Network, it also supports testing of a number of biological products (blood derivatives and vaccines for human use, vaccines for veterinary use) by OMCLs in the context of official control authority batch release of such products, by elaboration of common procedures and guidelines.

Finally, it organises market surveillance of products that have received a centralised Community Marketing Authorisation according to a work programme set by the European Medicines Agency (EMA, London).

HealthCare & HealthCare PracticesBlood transfusion and organ transplantation The blood transfusion work programme is based on three main principles: • no commercial use of products of human origin,• voluntary, non-remunerated donations,• protecting the health of donors and recipients.

Activities are focused on studying the ethical, legal and organisational aspects of blood transfusion with a view to ensuring quality, increasing availability, avoiding wastage, ensuring optimal use of supplies and analysing the possible ethical and organisational impact of new scientific developments.

The organ transplantation work programme is based on the following principles:• guaranteeing human dignity,• striving to maintain and improve the protection of human

rights and fundamental freedoms,

• ensuring that there is no commercial use of products of human origin,

• protecting donors and recipients.

The EDQM works to defend these major principles by elaborating guidelines in cooperation and collaboration with the European Union, the World Health Organisation (WHO) and other international organisations.

Counterfeit medicines Protecting patients in Europe from counterfeit medicines - a multisectorial programmeCounterfeit medicines pose a significant risk to public health. The EDQM supports efforts to protect and promote public health and tackle the threats to public health posed by counterfeit medicines and similar crimes.

In 2003, an “Ad hoc” Group on Counterfeit Medicines was created which is in charge of establishing a specific action plan, information exchange, risk management procedures and rapid alert systems as well as training programmes and conferences. The “Ad hoc” Group’s composition and project approach are multisectorial, bringing together officials from Council of Europe member states, European institutions, associations of pharmaceutical industry and trade and international organisations (e.g. WHO, European Commission, European Patent Office).

The EDQM regularly organises training courses with the support of national authorities, to help countries fight more effectively against counterfeit medicines. Since 2007, several courses have been organised for Council of Europe member states and more than 100 officials from 40 member states have completed the training to date.

Legal classification of medicinesThe legal classification of medicines as regards their supply with or without a medical prescription has implications on patient safety, the accessibility of medicines to patients and the responsible management of health care expenditure.An expert committee on medicines subject to prescription is entrusted to:• revise the text of the Resolution on the classification of

medicines, which are obtainable on prescription as appropriate;

• revise annually the classification of substances appended to the resolution;

• constitute a privileged platform for concerned authorities to exchange information on classification practice and rationale.

The Committee of experts is also in charge of the database on the classification of medicines, hosted by the Council of Europe, networking with other international databases in this field (European Medicines Agency, Deutsches Institut für Medizinische Daten und Information (DIMDI), WHO Centre for Drug Statistics Methodology, and the EURO-MED-STAT project that gathers information on the utilisation of medicines).

Consumer health protection: new challenges for the EDQMThe EDQM is also engaged in efforts to improve consumer health protection in Europe. These activities are aimed at developing harmonised approaches to product quality and safety in two areas: cosmetic products, including borderline products such as tattoos and permanent make-up, and packaging materials for food and pharmaceutical products.

As a consequence, the EDQM hosts three new Committees:• a Steering Committee for the management of the work

programme and decision-making: the Consumer Health Protection Committee, and

• two expert Committees that examine health-related issues and evaluate the risks, draft reports and recommendations for regulatory approaches.

In the field of cosmetics, preparatory work has begun on the drafting of a list of colourants suitable for use in tattoo inks. This work is being carried out in cooperation with safety assessors from participating national authorities. In addition, work on safety monographs for active cosmetic ingredients is continuing. The Committee of experts on packaging materials for food and pharmaceutical products has given priority to work on metals and alloys that are used in the manufacture food packaging or other articles in contact with food.

ORGANISATIONAL CHART OF THE *

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Organisational chartEuropean Directorate for the

Quality of Medicines & HealthCare

*The EDQM is a WHO Custodian Centre for the International Standards for Antibiotics (ISA) and is responsible for the establishment and distribution of WHO’s International Chemical Reference Standards (ICRS).

Management of dossiers & Scan Archives

MicrobiologyHealthCare &HealthCare Practices

Biological Standardisation

BiologyOMCL Network

International Harmonisation

Electronic PublicationsDivision B

Biological Experts Groups & Misc.

Division AChemical Experts Groups &

Misc.

Editorial ActivitiesPaper Publications

Physicochemistry

Translators Unit

Databases

Technical Secretariat XML Secretariat Variations & Quinquenial renewal

Procurement of Samples/Reagents

consumables

Div. Certification of substances

(DCEP)

Dispatch Safety & Transport Regulations Compliance

EvaluationTSE products

Samples management

Div.Ref. Standards & Samples (prod.

Dispatch)(DRS)

EvaluationChemical Substances

Manufacturing of Ref. Standards

Inspection

European Pharm.Dept.(EPD)

Dept.Publications &

Multimedia(DPM)

Dept. Biological Standard.,

OMCL Network& HealthCare

(DBO)

Dept.Laboratory (Dlab)

Public Relations& Documentation

Division(PRDD)

Sales

Events Budget

Administration &Finance Division

(AFD)

Communications& Multimedia

Quality & Audit

Environment & Safety

General building services

Human Resources

Information, Helpdesk,Archives & Documentation

Director

• Blood Transfusion

• Organ Transplantation

• Pharmaceutical Questions / Counterfeits

• Consumer Health Protection

Quality, Safety &Environment Unit (QSEU)

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A European Pharmacopoeia to guarantee the quality of medicines in Europe: this idea was the basis for the Convention (or international treaty) adopted by the Council of Europe in 1964.

Importance of the European Pharmacopoeia to patientsThe European Pharmacopoeia contributes to ensuring the quality of medicines by elaborating compulsory quality standards and control methods. This means a patient can buy a medicine (such as aspirin tablets) in a pharmacy in any European country and obtain the same quality regardless of the brand or type of medicine (original product or generic).

1964: Eight countries decided to come togetherOn 22 July 1964, Belgium, France, Germany, Italy, Luxembourg, the Netherlands, Switzerland and the United Kingdom signed the Convention on the Elaboration of a European Pharmacopoeia. For the first time in their history they undertook to harmonise their national pharmacopoeias and replace their national rules by a common supranational set of rules. This work on the elaboration of a European Pharmacopoeia in 1964 marked the beginning of the construction of a European regulatory framework for medicines which today covers a medicine from the time it is developed to the end of its life-cycle.From the beginning, several international organisations have participated in this work as observers: the European Economic Community (EEC) - today the European Union - and the World Health Organisation (WHO).

2010: The Convention has been ratified by 36 European countries and the European UnionThe European Pharmacopoeia is also used as a reference by many other countries, both European and non-European, some of which have official observer status. Observers can follow the work of the Commission by participating in the scientific discussions, but they do not have the right to vote. However, they may choose to implement the standards of the European Pharmacopoeia, in whole or in part, on their territories. Several countries therefore refer directly or indirectly in their national regulations to the European Pharmacopoeia (Canada, Australia, Morocco, Tunisia, Algeria, Senegal, etc). The WHO has been an observer since the 4th session of the Commission and has been participating in the meetings of the Commission since 1966.

23 Observers: 22 countries and WHO:• European countries: Albania, Armenia, Georgia, Kazakhstan,

Moldova, Republic of Belarus, Russian Federation and Ukraine.

• Non-European countries: Algeria, Argentina, Australia, Brazil, Canada, China, Israel, Madagascar, Malaysia, Morocco, Senegal, Syria, Tunisia and USA.

Special relations with the United States and Japan(See chapter 5).

THE EUROPEAN PHARMACOPOEIA IN BRIEF

AlgeriaArgentinaAustraliaBelarusBrazilCanadaChinaIsraelKazakhstanMadagascarMalaysiaMoroccoSenegalSyriaTunisiaUnited States of America


Observers countriesnon-members ofthe Council of Europe

Europe

Member states

Observer states

Portugal

Spai n Italy

Greece

Ukraine

Romania

Moldova

Austria

Turkey

Cyprus

Czech Rep. Slovak Rep.

Hungary

Finland

Sweden

Norway

United Kingdom

Ireland

Iceland

Denmark

France

Polan d

Lithuania

Latvia

Estonia

Bulgaria

Georgia

Belarus

Syria

Armenia

FYROM the Former Yugoslav Rep. of Macedonia

Luxembourg

Croatia

Malta

Albania

Serbia

Montenegro

Bosnia and Herzegovina

Slovenia

Switzerland

The Netherlands Germany

Belgium

Russian Federation Russian Federation

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Observers countriesnon-members ofthe Council of Europe

Europe

Member states

Observer states

Portugal

Spai n Italy

Greece

Ukraine

Romania

Moldova

Austria

Turkey

Cyprus

Czech Rep. Slovak Rep.

Hungary

Finland

Sweden

Norway

United Kingdom

Ireland

Iceland

Denmark

France

Polan d

Lithuania

Latvia

Estonia

Bulgaria

Georgia

Belarus

Syria

Armenia

FYROM the Former Yugoslav Rep. of Macedonia

Luxembourg

Croatia

Malta

Albania

Serbia

Montenegro

Bosnia and Herzegovina

Slovenia

Switzerland

The Netherlands Germany

Belgium

Russian Federation Russian Federation

POLITICAL DIMENSION OF THE EUROPEAN PHARMACOPOEIA IN 2010

HOW THE EUROPEAN PHARMACOPOEIA WORKSC

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The European Pharmacopoeia is a model of European co-operation. By pooling the knowledge and expertise of its member states, it has created an area in which there is a common European quality.

The Convention: elaborated in 1964 and still perfectly suited to the work of the European PharmacopoeiaThe Convention provides the legal framework for the European Pharmacopoeia and establishes its obligatory nature. The countries that sign and ratify the Convention willingly undertake to elaborate a common pharmacopoeia and to take the necessary measures to ensure that the European Pharmacopoeia texts that will be adopted shall become the official standards applicable within their respective territories. These texts, which are adopted by a unanimous decision, can be used immediately and directly in the member states without requiring further approval by the national authorities.

The Convention: the legal framework for the work of the European Pharmacopoeia CommissionThe Convention established its executive organs: the European Pharmacopoeia Commission and a permanent secretariat (this is part of the EDQM, Council of Europe [see chapter 1]). The Convention also defines the objectives and area of activity of the Commission and its decision-making process (unanimous vote for technical and scientific matters), a broad outline of its functions (this is supplemented by the Rules of Procedure), and the role of its Technical Secretariat.

A protocol to amend the Convention was adopted in 1994 to prepare for the accession of the European Union and define the respective powers of the European Union and its member states in the European Pharmacopoeia Commission.

The European Pharmacopoeia Commission Who attends the Commission?The European Pharmacopoeia Commission consists of 37 delegations (36 member states plus the delegation of the European Union, a representative of the Pharmaceuticals Unit (DG Sanco)). The European Medicines Agency (EMA) participates as an observer. Each member state is represented by a delegation consisting of not more than three persons from the health ministry, regulatory authorities, pharmacopoeias, universities, or industry who are appointed by the national authorities on the basis of their expertise.

WHO (since 1964) and a large number of countries participate in the work of the European Pharmacopoeia Commission as observers. Several European countries have chosen observer status before becoming full members; this gives them time to familiarise themselves with the texts and make the changes to their national regulations that are required for accession.

Role of the CommissionThe Commission determines the general principles applicable to the elaboration of the European Pharmacopoeia; it decides the programme of work of the European Pharmacopoeia, sets up and appoints experts to specialised groups responsible for preparing monographs, and adopts these monographs and recommends the fixing of the time limits within which its decisions shall be implemented within the territories of the contracting parties.

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Programme of work of the European Pharmacopoeia Items are added to the programme of work in response to requests from the member states and Community authorities received by the Secretariat, based on current scientific and health issues in Europe.

Sessions of the CommissionThe Commission meets behind closed doors in Strasbourg three times a year to adopt texts proposed by its groups of experts and to decide on its programme of work and general policies. Each national delegation has one vote. On all technical matters, decisions of the Commission are taken by a unanimous vote of national delegations casting votes. The Commission works in English and French, the official languages of the Council of Europe. Since 1964, there have been 136 sessions of the Commission in Strasbourg and 15 terms of office of the Chair of the Commission. Chairs are elected to 3-year terms and they cannot be re-elected immediately.

Groups of experts are set up to respond to current scientific and public health issuesAt the beginning in 1964 there were 13 groups of experts; in 2010 there are 19 permanent groups supplemented by 47 “ad hoc” specialised working parties which meet as required by the work programme of the European Pharmacopoeia. “Ad hoc” working parties are created to enable the European Pharmacopoeia to deal with new scientific and technical developments. For example, a “Cell Therapy products” working party was established in 2009 to cover advanced therapies, a “Procedure 4 for Biologicals” working party to take account of the growing importance of biotechnologically produced active substances.

The European Pharmacopoeia is elaborated collectively by experts from all the member states, from universities, the pharmaceutical and chemical industries that produce raw materials (active substances and excipients), national control laboratories for medicines, national competent authorities responsible for medicines, inspectorates, or any other relevant scientific profession.

The experts are proposed by their national delegation and are nominated by the Commission on the basis of their expertise. All the meetings of groups of experts take place in Strasbourg (France), the headquarters of the Council of Europe.

The draft texts prepared by the groups of experts are published in their entirety in a periodical called “Pharmeuropa”, and readers have three months to submit comments on these texts. The respective group of experts then analyses the comments, revises the text if necessary and submits it to the Commission for adoption.

What kind of medicines are covered by the European Pharmacopoeia?European Pharmacopoeia standards apply to all medicines regardless of their origin (chemical, biological or herbal), their method of production (e.g. chemical, biotechnology-derived products or genetic engineering) or their type (homoeopathic medicines, originator or generic medicines, vaccines, etc). A wide range of subjects is described: active substances, excipients and even materials used in containers. It includes over 2130 monographs on preparations and substances and nearly 330 general methods of analysis.


The Council of the European Union and the European Commission (Brussels)

European Medicines Agency (EMA, London)

European Directorate for the Quality of Medicines & HealthCare (EDQM)Council of Europe (Strasbourg)

EuropeanDirectorate

for the Qualityof Medicines& HealthCare

EDQMStrasbourg

European Union

Council ParliamentCommission

SancoBrussels

EuropeanMedicines Agency

EMA****London

Councilof Europe

European Union

European Authorities

OMCL

Inspection

Licensing

National Authorities

PharmacopoeialSecretariat

Ph. Eur.**

Certification***

OMCL*Network

OrganTransplantation

Pharmaceuticals/Pharmaceutical

Care

ConsumerHealth

Protection

BloodTransfusion

*OMCL: Official Medicines Control Laboratories**Ph.Eur: European Pharmacopoeia***Certification: Certification of Suitability of Monographs of the European Pharmacopoeia ****EMA: European Medicines Agency

HOW THE EUROPEAN PHARMACOPOEIA HAS ADAPTED TO GLOBALISATION OF TRADE IN MEDICINAL PRODUCTS: THE CERTIFICATION PROCEDURE

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The certification procedure, set up in 1994, provides a centralised evaluation service for manufacturers of raw materials for pharmaceutical use as well as for licensing authorities in Europe.

The procedure concerns the evaluation of quality with respect to the criteria prescribed in the relevant monograph(s).

A certificate of suitability (CEP) guarantees that the application of the relevant European Pharmacopoeia monographs (when necessary supplemented with additional tests annexed to the certificate) makes it possible to control that the quality of the substance is appropriate for use in medicines. It guarantees that all the impurities and potential contaminations related to the manufacturing process (including the manufacturing site and raw materials) are satisfactorily controlled applying the requirements of these monographs.

The certificates granted in Strasbourg by the EDQM are recognised by the signatory states to the European Pharmacopoeia Convention and a number of other countries, e.g. Canada. They are referred to in the EU pharmaceutical legislation and can be used by marketing authorisation applicants to demonstrate that their products and the substances they use comply with the requirements of the European Pharmacopoeia monographs and with EU pharmaceutical legislation.

So far, more than 3100 certificates have been granted to manufacturers in nearly 60 countries from every continent for about 850 substances or preparations, used in the manufacture of medicines.

A company that wishes to apply for a certificate sends the EDQM a detailed dossier that describes the manufacturing process and the tests performed on the raw materials. This dossier should show that their product complies with the quality required by the European Pharmacopoeia and in particular that the monograph can be used to control the impurities. The applicant must also agree to comply with Good Manufacturing Practice (GMP). The dossier is processed according to a procedure that guarantees the confidentiality of intellectual property and is evaluated by experts nominated by national competent authorities of participating countries with impartial status who have additionally signed a confidentiality agreement.

The certification procedure of the EDQM is based on a Resolution of the Public Health Committee (Partial Agreement) AP/CSP (93) 4; it is regularly revised so that new risks to public health can be dealt with.

The scope of the procedure was extended in 1999 to minimising the risk of transmitting agents of animal spongiform encephalopathies (TSE risk, “mad cow disease”). As a result the procedure now covers products of ruminant origin used in the preparation of active substances, excipients and any raw materials, intermediates or reagents used in their manufacture (e.g.: bovine serum albumin, enzymes, culture media, etc.). This ensures that the precautionary principle is applied to all categories of products used to manufacture medicines.

The EDQM’s Certification Division is also responsible for the organisation of the on-site inspections and their follow-up, including the implementation of any subsequent action regarding the related CEPs and communication with the concerned authorities. The aim is to verify compliance with GMP and the Certificate of Suitability application documentation and any subsequent updates at the manufacturing/distribution sites covered by CEPs. These inspections are carried out as team inspections by official inspectors from the competent supervisory authorities of Member States of the European Union (EU)/European Economic Area (EEA), from countries which have a Mutual Recognition Agreement (MRA) with the EU in the GMP sector, or in some cases from WHO, and EDQM inspectors. For inspections carried out in non-EEA member states, local inspectors are also invited to participate.Around 35 inspections are carried out each year, mainly in Asia. When an inspection has a negative outcome and actions are taken on CEPs, information is published on the EDQM website and is circulated amongst the relevant licensing and supervisory authorities.The EDQM’s Certification Division is also involved in some international projects on sharing information related to inspections of Active Pharmaceutical Ingredients.

In 2009, the Certification procedure received ISO 9001:2008, an internationally recognised standard for quality management systems. This certification highlights the EDQM’s commitment to quality processes, ensuring efficient provision of quality products and services.

* International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Products (VICH) among the regulatory authorities of Europe, Japan and the United States.


THE EUROPEAN PHARMACOPOEIA AND THE INTERNATIONAL HARMONISATION PROCESS WITH THE UNITED STATES AND JAPANC

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At this time of rapid technological and scientific change and globalisation of trade, the EDQM is following a policy of openness and dialogue with its partners and counterparts: the national authorities, the European Union, WHO, the pharmaceutical and chemical industries, and producers of raw materials all over the world.

The European Pharmacopoeia and ICH/vICH*The EDQM represents the European Pharmacopoeia in the tripartite programme for harmonisation of regulatory requirements between the European Union, Japan and the United States through ICH/VICH. This tripartite programme on the harmonisation of requirements on the development, testing and surveillance of medicines was set up in 1990 by the United States, the EU and Japan and is aimed at reducing the overall costs of development, manufacture and control of medicines in the world by harmonising regulatory requirements, thus avoiding duplication of work and reducing the time to market. This work contributes to an increased availability of medicines to patients, especially for diseases of critical importance.

The European Pharmacopoeia and its counterparts in Japan and the United States also participate in work on the quality aspects of medicines.

The European Pharmacopoeia and the Parmacopoeial Discussion GroupThe European Pharmacopoeia is one of the cofounders of the Pharmacopoeial Discussion Group (PDG) set up in 1990 with the Japanese and United States pharmacopoeias. This group meets regularly (twice a year) with the location rotating between Europe, Japan and the United States in parallel to the meeting of ICH, thus keeping developments synchronised. European, American and Japanese manufacturers’ associations in the pharmaceutical industry play an active role in identifying the priorities in the programme of work of the PDG. WHO participates as an observer at PDG meetings.

In line with the goals of ICH/VICH, the main objective of this programme of work is to reduce the development and production costs of medicines by adopting common standards harmonised all over the world so that, for a product manufactured at the same site and marketed in different countries, the manufacturer does not have to repeat testing according to different specifications for the various pharmacopoeias (Europe, Japan and United States).

Since 2001, the PDG has been organising hearings for representatives of the pharmaceutical and excipient industries to facilitate exchanges and synergy. Each pharmacopoeia is responsible for working on part of the international harmonisation programme, which is established jointly. Users may be consulted on this work through the various forum publications or even through international meetings attended by the other two pharmacopoeias and the parties concerned, to arrive at a consensus. The relevant European Pharmacopoeia groups of experts all work on this programme.

Texts harmonised at tripartite level are identified in each pharmacopoeia.

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How to contact usInformation and Internet orders: www.edqm.eu

Any question should be submitted through the HELPDESK, which is accessible through the EDQM internet site atwww.edqm.eu/hdFor all other subjects, please send an e-mail to: [email protected]

Tel.: +33 (0)3 88 41 30 30*Fax: +33 (0)3 88 41 27 71**leave out the (0) if calling from outside France

Postal addressEuropean Directorate for the Quality of Medicines & HealthCare (EDQM)7 allée Kastner, CS30026F – 67081 Strasbourg - France

HOW TO CONTACT THE EDQM ?

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European Directorate for theQuality of Medicines & HealthCare

edqm brochure updated june 2010

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