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The importance of dialogue between regulators

The importance of dialogue between regulators. Prof. Vincenzo Salvatore Head of Legal Sector British Institute of International and Comparative Law London, 21 April 2006. We (have to) dialogue with …. European Commission NCAs Council of Europe/European Pharmacopeia WHO FDA

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

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

  4. … 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.

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

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

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

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

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