The Pharmacovigilance Risk Assessment Expert Committee (PRAEC) has recommended regulatory action against specified substandard or falsified medical products, enhanced safety monitoring and suspension of marketing authorizations in selected cases.
Regulatory action recommended against substandard medicinal products
ISLAMABAD, Oct 27 (APP):The Pharmacovigilance Risk Assessment Expert Committee (PRAEC) has recommended regulatory action against specified substandard or falsified medical products, enhanced safety monitoring and suspension of marketing authorizations in selected cases.
The recommendations were made during the committee’s seventh meeting held at the Drug Regulatory Authority of Pakistan (DRAP), where members reviewed medicine safety concerns and measures to strengthen adverse drug reaction (ADR) reporting in the country.
The committee assessed domestic medicine safety cases and considered international regulatory decisions arising from pharmacovigilance data to evaluate potential risks associated with pharmaceutical products.
The meeting highlighted the importance of effective pharmacovigilance in identifying emerging safety concerns, assessing potential risks and supporting evidence-based regulatory decisions.
Adverse drug reaction reporting helps regulators detect possible medicine-related problems and take timely action to protect public health.
The committee’s recommendations form part of ongoing efforts to strengthen medicine safety monitoring and ensure that regulatory decisions are guided by scientific evidence and patient safety considerations.
