The European Medicines Agency's use of prioritised independent research for best evidence in regulatory action on diclofenac

Author:

Arlett Peter1,Sarac Sinan B.2,Thomson Andrew3,Davies Claire3,Teixeira Tania1,Blake Kevin V.1,Stenver Doris2

Affiliation:

1. European Medicines Agency; London UK

2. Danish Health and Medicines Authority; Copenhagen Denmark

3. Medicines and Healthcare products Regulatory Agency; London UK

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Reference12 articles.

1. tEuropean Medicines Agency Benefit-risk methodology http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000314.jsp&mid=WC0b01ac0580665b63

2. Gatekeepers and enablers: how drug regulators respond to a challenging and changing environment by moving toward a proactive attitude;Ehmann;Clin Pharmacol Ther,2013

3. Advancing the science of medicines regulation: the role of the 21st-century medicines regulator;Lumpkin;Clin Pharmacol Ther,2012

4. Increasing scientific standards, independence and transparency in post-authorisation studies: the role of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance;Blake;Pharmacoepidem Drug Saf,2012

5. The pharmacoepidemiological research on outcomes of therapeutics by a European Consortium (PROTECT) project http://www.imi-protect.eu/

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