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The importance of dialogue between regulators

This article discusses the significance of dialogue between regulators in ensuring the quality, safety, and efficacy of medicinal products. It highlights the partnerships between the European Medicines Agency (EMA) and various stakeholders, including the European Commission, National Competent Authorities (NCAs), Council of Europe, World Health Organization (WHO), and the Food and Drug Administration (FDA). The article also emphasizes the need for balancing public health interests and corporate financial health interests in dialogue with the pharmaceutical industry. Additionally, it addresses future challenges and opportunities for expanding cooperation with non-EU countries.

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The importance of dialogue between regulators

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  1. The importance of dialogue between regulators Prof. Vincenzo Salvatore Head of Legal Sector British Institute of International and Comparative LawLondon, 21 April 2006

  2. The European Medicines Agency • Evaluation, supervision and pharmacovigilance of medicinal products • Working for quality, safety and efficacy of medicines in Europe • Partnership with more than 40 NCAs based in 28 EU and EEA countries

  3. We (have to) dialogue with …. • European Commission • NCAs • Council of Europe/European Pharmacopeia • WHO • FDA • Other institutional partners (EP, EFSA, EMCDDA, ECDC, etc.) … regulators

  4. But we (have to) dialogue also with …. • Industry • Patients • Healthcare professionals … stakeholders

  5. … incidentally, there could be a slightly different approach: Whilst dialogue between regulators is focused on how to ensure better public health interest protection, … dialogue with industry may be affected by the tendency of pharma companies to seek an equitable balance between general public health interest and corporate financial health interest.

  6. Dialogue with regulators • EUROPEANCOMMISSION our major institutional partner • Regular bilateral and teleconference • Two representatives in the Management Board • Representatives from the Commission in major meetings • Close EMEA/EC Cooperation in implementing legislation

  7. Dialogue with regulators • NATIONAL COMPETENT AUTHORITIES • Heads of Medicines Agencies • One representative each in the Management Board • NTA meetings • CMD meetings • Flow of information concerning PhV issues and, more in general, safety, quality and efficacy of medicinal products

  8. Dialogue with regulators • COUNCIL OF EUROPE • EDQM - European Directorate for the Quality of Medicines • European Pharmacopeia • Dialogue and cooperation in the field of inspections • EEA OMCLs network

  9. Dialogue with regulators • WORLD HEALTH ORGANISATION • Assistance to non EEA member countries • Cooperation and consultation provided for by art. 58 of Regulation (EC) 726/2004 • First positive opinions released by CHMP on 17 November 2005

  10. Dialogue with regulators • FOOD AND DRUG ADMINISTRATION • Regular bilateral and teleconference • Meeting FDA/EMEA/European Commission • Provision of parallel scientific advice and exchange of information concerning Q,S & E of medicinal products + regulatory & legal issues • Confidentiality arrangement

  11. Already in the agenda • Pre-accession dialogue = PERF, PHARE • Increase cooperation/interaction with non-EU countries (i.e. Japan) • Mutual recognition agreements

  12. A NEW CHALLENGE FOR THE FUTURE … export the network model! • Latin/South America cooperation • ASEAN

  13. Thank you For further information: www.emea.eu.int

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