Pakistan Drafts Pharmacovigilance Guidelines

| By | Guideline, Pakistan, Pharmacovigilance

The Drug Regulatory Authority of Pakistan (DRAP) has published draft pharmacovigilance guidelines. The document provides a basic framework for pharmacovigilance in an attempt to operationalize the monitoring of drug safety in Pakistan.

Pharmacovigilance practices are less well-established in Pakistan than in many other parts of the world. Last year, Pakistan became the 134th full member of the World Health Organization (WHO) Programme for International Drug Monitoring (PIDM). Countries including Liberia, Niger and Sudan joined WHO-PIDM before Pakistan.

Having entered the program, Pakistan is now working to improve its pharmacovigilance operation. In the guidelines, DRAP cites the creation of the Pakistan National Pharmacovigilance Centre (PNPC) and the encouragement of healthcare professionals to report adverse events among its near-term goals. In the longer term, DRAP wants to make adverse event reporting mandatory and detect safety signals in its pharmacovigilance database.

The guidelines provide an overview of the infrastructure that will help DRAP work toward its near and longer-term goals. In the text, DRAP describes PNPC and the Pharmacovigilance Risk Assessment Expert Committee, as well as the interactions of these and other organizations and the functions of people who will work at them.

DRAP also sets out what it expects of different groups affected by pharmacovigilance, including the holders of drug marketing authorizations. The agency expects these companies to establish systems for managing pharmacovigilance activities and nominate qualified persons to maintain the systems and communicate with PNPC.

DRAP is accepting feedback on the draft guidelines via email.

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