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Are the European Medicines Agency, US Food and Drug Administration, and Other International Regulators Talking to Each Other?
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 i...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7028217/ https://www.ncbi.nlm.nih.gov/pubmed/31449664 http://dx.doi.org/10.1002/cpt.1617 |
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author | Teixeira, Tania Kweder, Sandra L. Saint‐Raymond, Agnes |
author_facet | Teixeira, Tania Kweder, Sandra L. Saint‐Raymond, Agnes |
author_sort | Teixeira, Tania |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-7028217 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-70282172020-02-19 Are the European Medicines Agency, US Food and Drug Administration, and Other International Regulators Talking to Each Other? Teixeira, Tania Kweder, Sandra L. Saint‐Raymond, Agnes Clin Pharmacol Ther Reviews 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. John Wiley and Sons Inc. 2019-10-24 2020-03 /pmc/articles/PMC7028217/ /pubmed/31449664 http://dx.doi.org/10.1002/cpt.1617 Text en © 2019 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Reviews Teixeira, Tania Kweder, Sandra L. Saint‐Raymond, Agnes Are the European Medicines Agency, US Food and Drug Administration, and Other International Regulators Talking to Each Other? |
title | Are the European Medicines Agency, US Food and Drug Administration, and Other International Regulators Talking to Each Other? |
title_full | Are the European Medicines Agency, US Food and Drug Administration, and Other International Regulators Talking to Each Other? |
title_fullStr | Are the European Medicines Agency, US Food and Drug Administration, and Other International Regulators Talking to Each Other? |
title_full_unstemmed | Are the European Medicines Agency, US Food and Drug Administration, and Other International Regulators Talking to Each Other? |
title_short | Are the European Medicines Agency, US Food and Drug Administration, and Other International Regulators Talking to Each Other? |
title_sort | are the european medicines agency, us food and drug administration, and other international regulators talking to each other? |
topic | Reviews |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7028217/ https://www.ncbi.nlm.nih.gov/pubmed/31449664 http://dx.doi.org/10.1002/cpt.1617 |
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