Marketing Authorization Applications Made to the European Medicines Agency in 2018–2019: What was the Contribution of Real‐World Evidence?-Reference-Cited by-同舟云学术

Marketing Authorization Applications Made to the European Medicines Agency in 2018–2019: What was the Contribution of Real‐World Evidence?

Published:2021-11-13 Issue:1 Volume:111 Page:90-97
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin Pharma and Therapeutics

Author:

Flynn Robert¹²,Plueschke Kelly¹,Quinten Chantal¹,Strassmann Valerie³,Duijnhoven Ruben G.¹⁴,Gordillo‐Marañon Maria¹⁵,Rueckbeil Marcia¹⁶,Cohet Catherine¹,Kurz Xavier¹

Affiliation:

1. Data Analytics and Methods Task Force European Medicines Agency Amsterdam The Netherlands

2. Medicines Monitoring Unit University of Dundee Dundee UK

3. Pharmacovigilance Office, Quality and Safety of Medicines Human Medicines Division European Medicines Agency Amsterdam The Netherlands

4. Amsterdam University Medical Centers University of Amsterdam Amsterdam The Netherlands

5. Institute of Cardiovascular Science Faculty of Population Health University College London London UK

6. Department of Medical Statistics University Hospital Aachen Aachen Germany

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2461

Reference22 articles.

1. Real‐World Data for Regulatory Decision Making: Challenges and Possible Solutions for Europe

2. Use of real-world evidence in postmarketing medicines regulation in the European Union: a systematic assessment of European Medicines Agency referrals 2013–2017

3. Assessing strength of evidence for regulatory decision making in licensing: What proof do we need for observational studies of effectiveness?

4. Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999–2014

5. Randomized Controlled Trials Versus Real World Evidence: Neither Magic Nor Myth

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