The Drug Regulatory Authority of Pakistan has revised and updated the requirements for grant of Drug manufacturing license and Post Licnese variations, in line with DRAP Act 2012, Drug Act 1976 and rules framed there under after adaptation of PIC/s Guidelines.
These requirements serve a reference document for the applicants intended to apply for grant of Drug Manufacturing Licenses and Post License variation .The requirements aim to facilitate harmonization with international regulatory requirements, enabling Pakistani manufacturers to meet the stringent standards required by international regulatory bodies and foreign regulatory authorities.
Accordingly, the 4th version of guidance document titled “ESTABLISHMENT OF PHARMACEUTICAL UNIT, GRANT AND RENEWAL OF DML-THEREOF, and 1st version of “POST LICENSE VARIATIONS “along with newly drafted ANNEXURES are uploaded on the official website of DRAP on the 30th of September , 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 abdullah.diyo∂dra.gov.pk and drapakbar∂gmail.com , zunairafaryad∂gmail.com or can be posted at the mailing address, Director, Division of Drug Licensing , Drug Regulatory Authority of Pakistan, Prime Minister’s National Health Complex, Park Road, Islamabad.
Month: September 2026
Establishment of Pharmaceutical Unit and Post License Changes(For Comments)
The Drug Regulatory Authority of Pakistan has revised and updated the requirements for grant of Drug manufacturing license and Post Licnese variations, in line with DRAP Act 2012, Drug Act 1976 and rules framed there under after adaptation of PIC/s Guidelines.
These requirements serve a reference document for the applicants intended to apply for grant of Drug Manufacturing Licenses and Post License variation .The requirements aim to facilitate harmonization with international regulatory requirements, enabling Pakistani manufacturers to meet the stringent standards required by international regulatory bodies and foreign regulatory authorities.
Accordingly, the 4th version of guidance document titled “ESTABLISHMENT OF PHARMACEUTICAL UNIT, GRANT AND RENEWAL OF DML-THEREOF, and 1st version of “POST LICENSE VARIATIONS “along with newly drafted ANNEXURES are uploaded on the official website of DRAP on the 30th of September , 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 abdullah.diyo∂dra.gov.pk and drapakbar∂gmail.com , zunairafaryad∂gmail.com or can be posted at the mailing address, Director, Division of Drug Licensing , Drug Regulatory Authority of Pakistan, Prime Minister’s National Health Complex, Park Road, Islamabad.
Due to maintenance work on the fiber-optic line of NTC. DRAP e-Services may remain disrupted today. We regret the inconvenience and appreciate your cooperation.
Regulatory Guidance for Local Manufacture Of Biological Products Using Imported Bulk Concentrate or Ready-To-Fill Bulk(For comments)
The Drug Regulatory Authority of Pakistan (DRAP) has developed this draft guidance to provide a clear and risk-based regulatory framework for the local manufacture of biological products using imported Bulk Concentrate (BC) or Ready-to-Fill Bulk (RTFB). The guidance outlines the regulatory expectations for manufacturers regarding imported biological materials, local manufacturing and filling operations, quality requirements, comparability and bridging, non-clinical and clinical data, and post-marketing safety and pharmacovigilance. It is intended to facilitate progressive localization while ensuring that the quality, safety and efficacy of biological products manufactured in Pakistan are appropriately maintained. Stakeholders are requested to review the draft Guidance Document and submit their written comments, suggestions, and inputs to muneeb.cheema∂dra.gov.pk within fifteen (15) days from the date of uploading of the document on the DRAP website.
Training of Online Pharmaceutical Track and Trace System for Implementation Of 2-D Barcode and Serialization (For Punjab industry)
Important Announcement – Temporary Suspension of Fee Challan Module
Please be informed that the Fee Challan Module is being temporarily disabled to facilitate the revision of the Fee Schedule and the necessary system updates.The module is tentatively expected to be enabled by 2:00 PM on Tuesday, 29 September 2026, subject to successful completion of the required updates.We apologise for any inconvenience caused and appreciate your cooperation and patience in this regard.