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.
Regulatory Updates
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.
96th Meeting of Medical Devices Board will be held on 22nd August 2025
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
List of Establishment License under MDR 2017 (Local)
List of Establishment License under MDR 2017 (Import)
Requirement of Bio-equivalence Studies as part of Registration Application
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.