Pakistan

Pharmacovigilance in Pakistan is regulated by the Drug Regulatory Authority of Pakistan (DRAP) through the National Pharmacovigilance Centre. The DRAP National Pharmacovigilance Guidelines and Pharmacovigilance Rules, 2022 require each registration or marketing authorisation holder to operate a pharmacovigilance system and appoint a Pakistan-resident QPPV; a multinational company may appoint a resident local safety officer. The MAH must maintain a DRAP-compliant PSMF, provide it within 45 calendar days when requested, manage signals and risks, and submit required PBRERs and RMPs. Domestic serious ICSRs are due within 15 calendar days and non-serious cases within 90 days. The official adverse-reaction reporting page identifies the available reporting channels, and the industry e-reporting implementation notice addresses electronic reporting by registration holders. DRAP may review the PSMF and inspect the pharmacovigilance system. These official DRAP sources replace secondary commercial summaries as the regulatory evidence. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): PSMF Maintenance: Concept and Importance in Pharmacovigilance.