Last Updated on March 16, 2024
Following guidelines are intended to help the industry and other applicants to meet the regulatory requirements related to the pharmaceuticals products.
1. Drug Manufacturing License
2. Drug Registration
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Guidance Document For Submission Of Application On FORM 5-F (CTD) For Registration Of Pharmaceutical Drug Products For Human Use .
English ( 444 KB – PDF)
![](https://i0.wp.com/www.dra.gov.pk/wp-content/uploads/2022/02/Guideline-Icon.png?resize=134%2C134&ssl=1)
Guidance on Preparation of Summary of Product Characteristics (SmPC)
English ( 386 KB – PDF)
![](https://i0.wp.com/www.dra.gov.pk/wp-content/uploads/2022/02/Guideline-Icon.png?resize=134%2C134&ssl=1)
Frequently asked questions about Form 5F (Common Technical Documents)
English ( 256 KB – PDF)
3. Post Approval Variations of Drugs
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Post Registration Variation Guidelines For Pharmaceutical and Biological Products
English ( 735 KB – PDF)
4. Non Routine Registration pathways for Drug Registration
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Priority Review and Accelerated Approval of Registration / Market Authorization
English ( 302 KB – PDF)
5. Reliance Mechanism
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Reliance Mechanism in Regulatory processes, A DRAP’s approach on Good Reliance Practices
English ( 454 KB – PDF)
6. Appeals Against Regulatory Decisions
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Guidelines for Filling an Appeal Against the Decisions of Statutory Bodies (e.g. Registration Board)
English ( 371 KB – PDF)