Home > News & Updates

News & Updates

Directive for Submission of Antimicrobial Batch Production and Import Data in DRIS

Yasir Mahmood Pharmacovigilance

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

Yasir Mahmood Drugs
  1. Streamlining The Evaluation and Processing of Form 5F (Common Technical Document) Applications Under S.R.O. 713(I)/ 2018.
  2. Submission of Summary of Product Characteristics (SmPC) And Patient Information Leaflet (PIL) Along with CTD Dossier (Form 5-F).​
  3. Borrowing of APIS for Performing Product Development, R & D and Stability Testing Registration Board Decision Thereof.
  4. Quality-Based Incentivisation of Applications for Local Manufacturers​
  5. 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​

Quality-Based-Incentivisation-of-Applications-for-Local-Manufacturers_Download

Revised Policy for Registration and Enlistment of Formulations Containing Vitamins and Minerals

Revised-Policy-for-Registration-and-Enlistment-of-Formulations-Containing-Vitamins-and-MineralsDownload