Will Transatlantic Regulatory Cooperation Meet Expectations? - Pharmaceutical Technology

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Will Transatlantic Regulatory Cooperation Meet Expectations?
There has been increasing cooperation between the EMA and the FDA in recent years, and this looks set to continue in the future. However, with both agencies having been criticised for their approval processes and safety monitoring, will greater regulatory harmonisation be beneficial to industry and accepted by consumers?

Pharmaceutical Technology Europe
Volume 22, Issue 11


In the future regulatory environment, there will be increased cooperation between the EMA and the FDA, and this is set to provide numerous benefits. At present, various projects focusing on different areas of drug regulation are underway to generate specific recommendations on how the cooperative measures will work in practice. A further development has been an exchange staff programme — the FDA has had a permanent representative in the EMA office in London (UK) since 2009 and the EMA adopted a similar approach earlier this year by placing a representative at the FDA headquarters in Maryland (USA).

Despite the progress being made, however, the agencies will need to ensure that they gain the support of both the pharma industry and the public. Only in this way will the true benefits of collaborative regulatory measures be realised.


1. European Medicines Agency, "European Medicines Agency and U.S. Food and Drug Administration extend confidentiality arrangements indefinitely" (2010).

2. European Medicines Agency, "Statement of authority and confidentiality commitment from the European Medicines Agency not to publicly disclose non-public information shared by the United States Food and Drug Administration" (2010).

3. European Medicines Agency, "Partners & networks: Regulators outside the EU: United States of America" (2010).

4. EuroPharma Today, "FDA and EMEA: Minding the Gap" (2009).

5. European Medicines Agency, "Transatlantic Administrative Simplification Action Plan Implementation report — 2009" (2009).

6. R. Lane, "Similarities and Differences between CMC Information required for EU IMPD CTA and US IND" (2008).

7. Biopharma Today, "Is FDA More Conservative Than EMEA? FDA Says No; Investors Weigh In" (2009).

8. Europharma Today, "FDA Not More Conservative Than EU, Jenkins Says; Investors Not Convinced" (2009).

9. Business Week, "Pfizer Withdraws Drug After Deaths, No Proven Benefit (Update1)" (2010).

10. New York Times, "FDA Official Admits 'Lapses' on Vioxx" (2005).

11. Eye on FDA, "The EMEA and the FDA" (2009).

12. The Lancet, "European Medicines Agency — more transparency needed" (May 2010).

13. European Ombudsman, "Ombudsman welcomes release of adverse reaction reports by the European Medicines Agency " (2010).

14. European Medicines Agency, "General principles EMEA — FDA Parallel scientific advice"

15. Financial Times, Pharmaceuticals: Perils for pill pushers (2010).

16. Pharma Times, "End of the road for Avandia: halted in EU, restricted in USA" (2010).


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