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Are the European Medicines Agency, US Food and Drug Administration, and Other International Regulators Talking to Each Other?
Author(s) -
Teixeira Tania,
Kweder Sandra L.,
SaintRaymond Agnes
Publication year - 2020
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.1617
Subject(s) - food and drug administration , agency (philosophy) , administration (probate law) , drug approval , pharmacology , public administration , drug , medicine , business , political science , law , sociology , social science
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.