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Review
. 2020 Mar;107(3):507-513.
doi: 10.1002/cpt.1617. Epub 2019 Oct 24.

Are the European Medicines Agency, US Food and Drug Administration, and Other International Regulators Talking to Each Other?

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Review

Are the European Medicines Agency, US Food and Drug Administration, and Other International Regulators Talking to Each Other?

Tania Teixeira et al. Clin Pharmacol Ther. 2020 Mar.
Free PMC article

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.

Conflict of interest statement

The authors declared no competing interests for this work.

Figures

Figure 1
Figure 1
Top topic areas discussed in clusters. Values shown are from aggregate results from a compiled list of the topic areas identified for all clusters. MAA, Marketing Authorisation Application; NDA, New Drug Application.
Figure 2
Figure 2
Quality of clusters rating from 1 to 4 (respondents n = 153). Scale: 1 = could be improved; 2 = ok; 3 = good; and 4 = excellent. Values shown are mean scores for the aggregate of all 20 clusters queried.
Figure 3
Figure 3
Overview of the European Medicines Agency (EMA)‐US Food and Drug Administration (FDA) cluster activities by month in 2018.

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References

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    1. International Conference of Drug Regulatory Authorities (ICDRA) . <https://www.who.int/medicines/areas/quality_safety/regulation_legislatio...>. Accessed July 8, 2019.
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    1. European Medicines Agency . International Partners <https://www.ema.europa.eu/en/partners-networks/international-activities/...>. Accessed March 15, 2019.
    1. European Medicines Agency . Confidentiality arrangements. <https://www.ema.europa.eu/en/documents/other/statement-authority-confide...>. Accessed July 19, 2019.

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