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.