The Changing Face of European Regulatory Affairs - Pharmaceutical Executive


The Changing Face of European Regulatory Affairs

Pharmaceutical Technology Europe


The European Medicines Agency is unique among global regulatory agencies because it operates on a networking model and because its area of geographic influence does not remain static. While this would appear to create numerous difficulties for the agency, it appears confident about its future and is already planning to extend its activities. Its expanding European responsibilities and wide range of contacts through its networking arrangements should tie in well with its desire to become a stronger force in international regulatory affairs.

Faiz Kermani is a freelance consultant and President of the Global Health Education Foundation, a charity that supports medical education and medical research projects in development countries. He is a member of Pharmaceutical Technology Europe's Editorial Advisory Board.


1. P. Le Courtois, Introduction to the EMEA (1st EMEA Workshop with Patient Organisations, 2002).

2. EMA, "About Us — Structure" (2010).

3. EMA, "New visual identity, web/e-mail addresses and organisation chart of the European Medicines Agency" (2009).

4. EMA, "The European Medicines Agency Road Map to 2010" (2004).

5. EMA, "EMEA and patients' and consumers' organisations" (2009).

6. EMA, "The European Medicines Agency Road Map to 2015: The Agency's Contribution to Science, Medicines, Health. Draft for Public Consultation" (2010).


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