Are the European Medicines Agency, US Food and Drug Administration, and Other International Regulators Talking to Each Other?
- PMID: 31449664
- PMCID: PMC7028217
- DOI: 10.1002/cpt.1617
Are the European Medicines Agency, US Food and Drug Administration, and Other International Regulators Talking to Each Other?
Abstract
There is talk of regulatory collaboration worldwide to protect public health and allow patients timely access to medicines. Here, we present the reality of the collaboration between the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). This takes the form of near daily interactions, which may be less known outside of regulatory agencies. We present a review of what we call clusters, which involve the EMA, the FDA, and many other agencies under the umbrella of confidentiality arrangements. Through a survey of participants, we identified about 30 clusters of variable composition; these allow for the exchange of information and discussion among experts of applying regulatory science to common challenges in global drug development at every phase of its lifecycle and facilitate global medicines development.
© 2019 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.
Conflict of interest statement
The authors declared no competing interests for this work.
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References
-
- International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. <https://www.ich.org/about/mission.html>. Accessed March 15, 2019.
-
- International Conference of Drug Regulatory Authorities (ICDRA) . <https://www.who.int/medicines/areas/quality_safety/regulation_legislatio...>. Accessed July 8, 2019.
-
- International Coalition of Medicines Regulatory Authorities (ICMRA) . <http://www.icmra.info/drupal/en>. Accessed July 8, 2019.
-
- European Medicines Agency . International Partners <https://www.ema.europa.eu/en/partners-networks/international-activities/...>. Accessed March 15, 2019.
-
- European Medicines Agency . Confidentiality arrangements. <https://www.ema.europa.eu/en/documents/other/statement-authority-confide...>. Accessed July 19, 2019.
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