PRAEC backs monitoring and marketing bans on unsafe drugs
At its seventh Islamabad meeting, the DRAP expert committee also called for stronger adverse reaction reporting and suspension of marketing authorisations in selected cases.
The Pharmacovigilance Risk Assessment Expert Committee (PRAEC) recommended regulatory action against specified substandard or falsified medical products.
It also urged enhanced safety monitoring and suspension of marketing authorisations in selected cases.
The recommendations came from PRAEC’s seventh meeting at the Drug Regulatory Authority of Pakistan (DRAP) in Islamabad on 27 October.
Members reviewed domestic medicine safety cases and international pharmacovigilance decisions, and discussed strengthening adverse drug reaction reporting.