The Drug Regulatory Authority of Pakistan has revised and updated the requirements for Establishment of pharmaceutical unit and also developed new guidance annexure VI (A) for requirements for grant of Drug manufacturing license by way of Basic and semi basic manufacturing for Blood and plasma Establishments in line with DRAP Act 2012, Drug Act 1976 and rules framed there under.
These requirements serve a reference document for the applicants intended to apply for grant of Drug Manufacturing Licenses for Blood/Plasma Establishments by way of basic/semi-basic manufacturing. The requirements aim to facilitate harmonization with international regulatory requirements, enabling Pakistani plasma establishments to meet the stringent standards required by international fractionators and foreign regulatory authorities.
These requirements are applicable to a broad range of entities and activities within the plasma supply chain. All Plasma Establishments that hold Drug Manufacturing Licenses and engage in the collection, testing, processing, storage, or distribution of plasma intended for fractionation must comply with these requirements. This also includes blood establishments that collect whole blood from which plasma is recovered, and plasma warehouses and distribution facilities that handle plasma after collection.
Accordingly, the 3rd version of guidance document titled “ESTABLISHMENT OF PHARMACEUTICAL UNIT AND POST LICENSE CHANGES “along with newly drafted Annexure VI ( A) REQUIREMENTS FOR GRANT OF DRUG MANUFACTURING LICENSE BY THE WAY OF BASIC & SEMI-BASIC MANUFACTURING FOR BLOOD/ PLASMA ESTABLISHMENTs are uploaded on the official website of DRAP on the 29th of December , 2025 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 akbar.ali∂dra.pk and drapakbar∂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.
Author: Yasir Mahmood
Submission of Required Details for Implementation of 2-D Barcode & Serialization by 1st September 2025
Drug Regulatory Authority of Pakistan (DRAP) is in process of implementing 2-D Barcode along with serialization for pharmaceutical products. In this regard, the pharmaceutical industry is hereby directed to provide the required details in the attached form not later than 1st September, 2025.
S.R.O. 1587(I)/2025 DRAP has adopted Pharmaceutical Inspection Co-operation Scheme (PIC/S) guidelines
Directive for Submission of Antimicrobial Batch Production and Import Data in DRIS
Registration holders of Pharmaceutical Products for human and veterinary use (manufacturers and importers) are directed to submit antimicrobials batch production / Import data (finished formulations) for use within Pakistan regularly in DRIS. DRAP will be analyzing yearly data for regulatory purposes. The data is critical for use in implementing Antimicrobial Stewardship Policies to combat AMR in Pakistan.
Recent Policy Updates and Procedural Guidelines for Drug Registration and Processing
- Streamlining The Evaluation and Processing of Form 5F (Common Technical Document) Applications Under S.R.O. 713(I)/ 2018.
- Submission of Summary of Product Characteristics (SmPC) And Patient Information Leaflet (PIL) Along with CTD Dossier (Form 5-F).
- Borrowing of APIS for Performing Product Development, R & D and Stability Testing Registration Board Decision Thereof.
- Quality-Based Incentivisation of Applications for Local Manufacturers
- Revised Policy for Registration and Enlistment of Formulations Containing Vitamins and Minerals
Streamlining The Evaluation and Processing of Form 5F (Common Technical Document) Applications Under S.R.O. 713(I)/ 2018.
Streamlining-The-Evaluation-and-Processing-of-Form-5F-Common-Technical-Document-Applications-Under-S.R.O.-713I2018Download
Submission of Summary of Product Characteristics (SmPC) And Patient Information Leaflet (PIL) Along with CTD Dossier (Form 5-F).
Submission-of-Summary-of-Product-Characteristics-SmPC-And-Patient-Information-Leaflet-PIL-Along-with-CTD-Dossier-Form-5-F._Download
Borrowing of APIS for Performing Product Development, R & D and Stability Testing Registration Board Decision Thereof.
Borrowing-of-APIS-for-Performing-Product-Development-R-D-and-Stability-Testing-Registration-Board-Decision-Thereof.Download
Quality-Based Incentivisation of Applications for Local Manufacturers
Revised Policy for Registration and Enlistment of Formulations Containing Vitamins and Minerals
Interview call for the post of Assistant Directors at DRAP, Lahore Office
Inauguration of online system for the applications of Medical Devices
We are thrilled to announce that the new MDMC Licensing and Registration module is officially launched.
This enhanced module has been designed to offer a more streamlined, efficient, and user-friendly experience for managing all MDMC licensing and registration activities.