Postmarket Safety Communication for Protection of Public Health: A Comparison of Regulatory Policy in Australia, Canada, the European Union, and the United States-Reference-Cited by-同舟云学术

Postmarket Safety Communication for Protection of Public Health: A Comparison of Regulatory Policy in Australia, Canada, the European Union, and the United States

Published:2020-10-11 Issue:6 Volume:109 Page:1424-1442
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Bhasale Alice L.¹^ORCID,Sarpatwari Ameet²^ORCID,De Bruin Marie L.³⁴^ORCID,Lexchin Joel⁵^ORCID,Lopert Ruth⁶,Bahri Priya⁴⁷,Mintzes Barbara J.¹^ORCID

Affiliation:

1. School of Pharmacy Faculty of Medicine and Health The University of Sydney NSW Australia

2. Program on Regulation, Therapeutics, and Law (PORTAL) Brigham and Women's Hospital Harvard Medical School Boston Massachusetts USA

3. Copenhagen Center for Regulatory Science Faculty of Health and Medical Sciences University of Copenhagen Copenhagen Denmark

4. Division of Pharmacoepidemiology and Clinical Pharmacology Utrecht Institute for Pharmaceutical Sciences Utrecht University Utrecht The Netherlands

5. York University Toronto Ontario Canada

6. George Washington University Washington DC USA

7. European Medicines Agency Amsterdam

Funder

National Health and Medical Research Council

Canadian Institutes of Health Research

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2010

Reference157 articles.

1. European Commission.Commission staff working document: Accompanying document to the Proposal for a regulation of the European Parliament and of the Council amending as regards pharmacovigilance of medicinal products for human use Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency and the Proposal for a directive of the European Parliament and of the Council amending as regards pharmacovigilance Directive 2001/83/EC on the Community code relating to medicinal products for human use. (Commission of the European Communities Brussels 2008).

2. European Commission.50 years of EU pharma legislation: Achievements and future perspectives[conference report]. (2015).

3. The FDA Amendments Act of 2007 — Assessing Its Effects a Decade Later

4. European Parliament and Council of Ministers.Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending as regards pharmacovigilance Directive 2001/83/EC on the Community code relating to medicinal products for human use.Official Journal of the European UnionVol. Directive 2010/84/EU (2010).

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