The Drug Regulatory Authority of Pakistan (DRAP) has established the National Pharmacovigilance Centre (NPC) under the Division of Pharmacy Services to oversee the safety monitoring of therapeutic goods across the country. The NPC works in close collaboration with national and international stakeholders to strengthen and sustain an effective pharmacovigilance system in Pakistan. Since 2018, Pakistan has been a full member of the World Health Organization Programme for International Drug Monitoring (WHO Programme for International Drug Monitoring), coordinated by the Uppsala Monitoring Centre (UMC), Sweden. At present, Pharmacovigilance Centres have been notified in all provinces, as well as within public health programmes, which contribute adverse event reports to the National Pharmacovigilance Database.
To facilitate timely reporting and effective safety surveillance, the NPC has developed a comprehensive, multi-channel reporting system for registration holders, hospitals, public health programmes, healthcare professionals, and the public. The Pharmacovigilance Rules, 2022 establish the legal framework governing pharmacovigilance activities in Pakistan and define the responsibilities of all stakeholders for maintaining pharmacovigilance systems and reporting safety data to the NPC.
Overall, these guidelines provide practical guidance to public sector stakeholders on the implementation of pharmacovigilance activities, covering the entire safety monitoring process from the identification and reporting of adverse events to signal detection, risk assessment, regulatory decision-making, and implementation of appropriate risk minimization measures. The guidelines have been comprehensively revised to reflect the evolving roles and responsibilities of stakeholders under the collaborative safety monitoring programme, align with current international best practices, and promote a coordinated, efficient, and transparent pharmacovigilance system. The revised guidance aims to clarify stakeholder responsibilities, eliminate duplication of efforts, strengthen collaboration among participating institutions, and enhance the quality and quantity of safety reporting across Pakistan.
The draft of revised guidelines is uploaded on the official website of DRAP on the 6th of July 2026 to seek comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using the prescribed format. For further guidelines on submitting comments, visit the DRAP website or click here. Comments and suggestions can be forwarded via email to pv∂dra.gov.pk or can be posted at the mailing address, Director, Division of Pharmacy Services, Drug Regulatory Authority of Pakistan, Prime Minister’s National Health Complex, Park Road, Islamabad.