The Drug Regulatory Authority of Pakistan (DRAP) has recently released the 2nd Edition of the Post Registration Variation Guidelines for pharmaceutical and biological drug products. These guidelines provide essential information for submitting post-registration variation applications by registration holders and marketing authorization holders of drug products. The guidelines distinguish between minor variations (MiV-N, MiV-PA) and major variations (MaV), with specific timelines for each type. Applicants are required to adhere to the prescribed “Form” and documentation requirements when submitting variation applications.
Author: Ijaz Mustafa
Prequalification of companies/ firms/ suppliers for supply of chemicals and glassware etc. to CDL Karachi
DRAP added New features in eAPP system enabling Online Submission for all types of Registration Applications of Drug Products
The Drug Regulatory Authority of Pakistan (DRAP) added a new e-service for online regulatory data submission for registration/marketing authorization of human drugs for local manufacturing, import and export. This e-service complements the existing one for licensing operations of all pharmaceutical and biological manufacturers, which are both accessible through the same platform. This e-service is part of the transformation strategy of the Drug Regulatory Authority of Pakistan, which aims to ensure the quality, safety and efficacy of therapeutic goods in Pakistan.
The e-service requires applicants to submit their data in a standardized format, as specified in the following type of submission:
- Registration of Drugs on Form-5F for human Use.
- Registration of Drugs on Form-5 & Form 5A for Veterinary Use.
- Application for Post Registration Variations.
- Renewal for Registration of Drugs
The new e-service allows applicants to submit their data electronically through the eAPP portal, which can be accessed after registering an account with DRAP. The e-service offers several benefits, such as:
- Faster and easier data submission and processing
- Reduced paper work and redundancy
- Increased transparency and visibility
This new e-service will facilitate the licensing and registration process and improve the regulatory system in Pakistan. DRAP will reach out to applicants in assisting application submission on this new eService.
We welcome your feedback and suggestions on how to improve our services. Please contact us at info∂dra.gov.pk or +92 51 9260 500 for any queries or assistance.
We hope that these new features will further enhance the efficiency and convenience of our e-service and facilitate the development and availability of quality therapeutic goods in Pakistan.
Tender for supply of chemicals, glassware, equipment and reference standards for National Control Laboratory for Biologicals (Retender)
Acceptance of IAEA technical reports on radiopharmaceuticals as regulatory reference
Tender for Supply of Lab Chemicals, Glassware, equipment and reference standards for National Control Laboratory for Biologicals (NCLB), Islamabad during the FY 2023-24
Tender for Office Supplies; Prequalification of companies / firms/ suppliers for provision of stationery and general office supplies.
116th Meeting of Enlistment Evaluation Committee (EEC); Notice for Submission of Deficient Information / Documents
The 116th meeting of Enlistment Evaluation Committee (EEC), Division of Health and OTC, DRAP was held on 23rd May, 2023. The detailed of applications which required further information and documentation is attached hereunder for information by all stakeholders.
114th Meeting of Enlistment Evaluation Committee (EEC); Notice for Submission of Deficient Information / Documents
The 114th meeting of Enlistment Evaluation Committee (EEC), Division of Health and OTC, DRAP was held on 26-27 January, 2023. The detailed of applications which required further information and documentation is attached hereunder for information by all stakeholders.
115th Meeting of Enlistment Evaluation Committee (EEC); Notice for Submission of Deficient Information / Documents
The 115th meeting of Enlistment Evaluation Committee (EEC), Division of Health and OTC, DRAP was held on 23 February 2023. The detailed of applications which required further information and documentation is attached hereunder for information by all stakeholders.