Afghanistan

Medicines safety oversight in Afghanistan is the responsibility of the Afghanistan Food and Drug Authority (AFDA). The official AFDA post-market services page is the relevant source for post-marketing oversight, while the AFDA website in Dari provides a national-language entry point. Marketing authorisation holders and importers should maintain arrangements to receive, evaluate and report suspected adverse reactions and comply with any product-specific safety conditions. The reviewed public sources do not establish a universal EU-style local QPPV, PSMF, fixed MAH ICSR timetable, routine PSUR/PBRER schedule or blanket RMP requirement. These elements should therefore be confirmed with AFDA for the product and authorisation route; they should not be presented as mandatory without a current Afghan rule or written authority confirmation. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.