Citation

Bhasale AL, Sarpatwari A, De Bruin ML, Lexchin J, Lopert R, Bahri P, Mintzes BJ. Clin. Pharmacol. Ther. 2020; ePub(ePub): ePub.

Copyright

(Copyright © 2020, American Society for Clinical Pharmacology and Therapeutics, Publisher Nature Publishing Group)

DOI

10.1002/cpt.2010

PMID

32767557

Abstract

In the wake of the rofecoxib withdrawal, regulators worldwide reconsidered their approach to post-market safety. Many regulators have since adopted a life-cycle approach to regulation of medicines, facilitating faster approval of new medicines while recognising and planning for post-market safety issues. A crucial aspect of post-market safety is the effective and timely communication of emerging risk information using post-market safety advisories, commonly issued as letters to healthcare professionals, drug safety bulletins, media alerts and website announcements. Yet regulators differ in their authority to issue post-market safety advisories. We examined the capacity of regulators in the United States, Europe, Canada, and Australia to warn about post-market safety issues by examining their governance, legislative authority, risk communication capabilities, and transparency.

Language: en