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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