Pakistan
Drug Regulatory Authority of Pakistan (DRAP)
Verified 12 September 2026 by Wilson Blaney, ACQI, RP (GDP) trained
4 days agoMarketing authorisation fees and the governing instrument were re checked against the regulator. Each amount is traceable to the schedule named in its note.
Contributor Wilson Blaney, ACQI, RP (GDP) trained
Pakistan regulates therapeutic goods through the Drug Regulatory Authority of Pakistan (DRAP), a federal autonomous body established under the DRAP Act, 2012. DRAP administers registration of pharmaceutical, biological and medical device products under the Drugs Act, 1976 and subordinate rules (notably the Drugs (Licensing, Registering and Advertising) Rules, 1976). Statutory registration decisions are made by the Registration Board, supported by Divisions of Pharmaceutical Evaluation & Registration (PE&R) and Biological Drugs (BE&R). DRAP operates standard registration and abridged / reliance pathways for products approved by Stringent Regulatory Authorities (SRAs) and WHO-prequalified products. Pakistan applies statutory price control on registered medicines through the Drug Pricing Policy 2018 (and subsequent revisions), administered by DRAP's Division of Pharmacy Services / Pricing Committee. The market is large (>240 million population) but heavily generics-focused.
About the authority
DRAP is the federal regulator for therapeutic goods in Pakistan, established under the DRAP Act, 2012. It comprises divisions for Pharmaceutical Evaluation & Registration (PE&R), Biological Drugs Evaluation & Research (BE&R), Medical Devices, Quality Assurance & Lab Testing, Pharmacy Services (pricing), and Pharmacovigilance. The Registration Board approves product registrations on the recommendation of the relevant division. The Central Licensing Board licenses manufacturers; provincial authorities (e.g., Punjab Drug Control) handle distribution and retail.
Reliance & recognition
DRAP recognises Stringent Regulatory Authority (SRA) approvals and WHO Prequalification as the basis for abridged review. Submissions still require a complete CTD dossier and local administrative documentation, but assessment focuses on the SRA report and CMC/labelling consistency.
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Other Asia-Pacific markets
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