International Conference of Drug Regulatory Authorities (ICDRA):

13th ICDRA in during 16-19 September 2008,

Berne, Switzerland

Dr Lembit RägoQuality Assurance and Safety: Medicines (QSM)

Essential Medicines and Pharmaceutical Policies (EPM)Health Technology and Pharmaceuticals (HTP)

ragol@who.int

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Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals

The International Conference of Drug Regulatory Authorities (ICDRA) provides drug regulatory authorities of WHO Member States with a forum to meet and discuss topics of interest and ways to strengthen collaboration.

The ICDRAs have been instrumental in guiding regulatory authorities, WHO and interested stakeholders in determining priorities for action in national and international regulation of medicines, biomedicines (including vaccines and blood products) and traditional medicines.

The conferences have been held since 1980 with the aim of promoting exchange of information and collaborative approaches to issues of common concern.

International Conference of Drug Regulatory Authorities (ICDRA)

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Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals

ICDRA: A PARTNERSHIP OF REGULATORY AUTHORITIES

STAKEHOLDERS

Regulatory Officials from all WHO regionsICDRA Planning Committee

Ministry of Health, SwitzerlandDepartment of Foreign AffairsMission Permanente de la Suisse, GenevaSWISSMEDIC

WHO Headquarters/Director-General, WHOWHO EURO/Regional DirectorWHO technical programmes Regional Advisers from WHO Regions: AFRO AMRO EMRO EURO SEARO WPRO

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Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals

The 13th ICDRA Pre-conference Berne 14th-15th September 2008

BETTER MEDICINES FOR CHILDREN:THE WAY FORWARD

It is recommended that the World Health Organization: Convene and collaborate with the global paediatric working group

of regulators; Work with civil society to mobilize and empower consumers,

parents, patients' groups and health professionals to advocate for better medicines for children;

Address high priority needs with achievable results including: Zinc for diarrhoea, pneumonia treatment, neonatal sepsis, HIV,

TB, malaria treatments, analgesia, drugs for chronic disease in children;

Take steps to identify the priorities and treatment guidelines needed for neonates;

Establish mechanisms to support drug development of new essential medicines for children.

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Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals

13th ICDRA PLENARY SESSIONS

Plenary 1: Opening Ceremony Welcome address. Christine Beerli, Chairwoman of the Institute Council,

Swissmedic, Switzerland Opening speech. Carissa Etienne, Assistant Director-General, World Health

Organization

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Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals

Plenary 2: Update on 12th ICDRA

Reflections on 12th ICDRA, Chung Keel Lee, Republic of Korea

WHO Progress Report, Hans Hogerzeil, WHO WHO Progress Report from countries: regional perspectives. WHO Regional Advisers on Pharmaceuticals: AFRO progress report, J. M. Trapsida AMRO/PAHO progress report, J. Fitzgerald EMRO Progress Report, Z. Mirza EURO, Progress Report, Kees de Joncheere SEARO, Progress Report, K. Weerasuriya WPRO, Progress Report, B. Santoso

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Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals

Plenary 3: Building mutual trust as a key to access (I)

WHO should: Promote, in a targeted and prioritized way, adoption and

implementation of the WHO Model Registration Package as minimum information requirements for product registration.

Produce a guidance and draft regulation for managing confidentiality issues among regulatory authorities.

Undertake joint assessments of selected applications, using the Model Registration Package.

Foster the development of regional, collaborative post-market surveillance and pharmacovigilance systems to monitor the quality, safety and efficacy of health products.

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Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals

Plenary 3: Building mutual trust as a key to access (II)

WHO should: Explore the potential development of an inter-agency e-

governance working group to harmonize electronic requirements to assist in the development of regulatory management systems and the sharing of information in accordance with established WHO international regulatory norms and standards.

In partnership with well-resourced regulatory authorities: establish formal mechanisms for the exchange and use of

regulatory information among all authorities to strengthen capacity and to maximize efficiencies, and

facilitate cooperation between small and medium well-resourced regulatory authorities to develop systems for the abbreviated assessment, approval and monitoring of health products.

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Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals

Plenary 4: Regulatory systems in a changing environment

Recommendations Member states should Facilitate and speed up global regulatory cooperation. Support and stimulate their regulatory authorities to work with

regional and global partners. WHO should: Continue to support and create new activities that stimulate

trust building and cooperation among regulatory agencies.

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Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals

Plenary 5. Crisis management: safeguarding health

Recommendations Member States should Have in place a standard operating procedure for communication in

times of crisis. Main initial communication difficulties which are linked to uncertainty of toxicity implications could be avoided by use of such SOPs.

… WHO and Member States should Work further to integrate and coordinate information and other

requirements in the International Health Regulations (IHR) (2005) with functions and activities of medicines regulatory authorities and related networks. Such integration could include establishing links between medicines regulatory authorities and their respective national IHR focal points, including potential access to the WHO IHR Event Information Site.

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Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals

Plenary 6: Current topics

Good Governance for Medicines Variations Challenges in regulating radiopharmaceuticals Involving consumers in medicines surveillance reporting. WHO Stability Testing Guideline Revision of WHO stability testing guidelines. WHO Certification Scheme Adverse reactions related to change of formulation:

thyroxine case.

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Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals

WORKSHOPS (I)

Workshop A: Regulatory aspects of paediatric medicines Workshop B: Development of regulation for herbal

medicines Workshop C: Safety and pandemic preparedness Workshop D: Regulatory approaches to proving

interchangeability Workshop E: Strategies to fight counterfeit medicines Workshop F: Emerging regulatory issues concerning

biosimilars and biologicals

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Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals

WORKSHOPS (II)

Workshop G: Emerging diseases: regulating blood products

Workshop H: Regulators contribution to access Workshop I: Update on harmonization initiatives Workshop J: Role of regulators in clinical trial approval Workshop K. Building regulatory capacity: best

practices for the future Workshop L. GMP inspections: impact of information

sharing and risk management

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OUTPUTS

• Report

• Recommendations

• Website

• Communications,Professional and personal contacts

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Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals

Next 14th ICDRA - where?

Singapore 2010