The Drug Regulatory Authority of Pakistan (DRAP) has drafted a guideline on the storage and destruction of recalled therapeutic goods, which are medicines, medical devices, and health products that do not meet the quality standards or are deliberately misrepresented. The guideline aims to provide a framework for the safe and effective management of such goods, from their identification and reporting to their disposal and documentation.
The draft guideline covers the following aspects:
- The roles and responsibilities of different stakeholders, such as manufacturers, importers, distributors, health care providers, and regulators, in handling substandard and falsified as well as recalled therapeutic goods.
- The criteria for selecting suitable storage facilities and methods for defective therapeutic goods.
- The methods for destroying in an environmentally sound manner.
- The records and reports that need to be maintained and submitted.
The draft guideline is available on the DRAP website on 27th October, 2023 for public consultation. DRAP invites comments and feedback from all stakeholders, including the pharmaceutical industry, health professionals, civil society organizations, and the general public. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using prescribed format. For further guidelines on how to submit comments visit DRAP website or click here. Comments and suggestions can be forwarded via email to ajmal.sohail∂dra.gov.pk, copying at sanaullah.babar∂dra.gov.pk, or can be posted at mailing address, Director, Quality Assurance & Lab Testing, Drug Regulatory Authority of Pakistan, 3rd floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.
DRAP appreciates the cooperation and participation of all stakeholders in ensuring the quality, safety, and efficacy of therapeutic goods in Pakistan.
The Medical Device Board (MDB) of the Drug Regulatory Authority of Pakistan in its 61st meeting has deferred the following applications of registration of medical devices due to various deficiencies/shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information/documentation as directed by the Medical Device Board. The detail is provided in the below attachment.
The Drug Regulatory Authority of Pakistan (DRAP) is pleased to announce the addition of a new e-service for online regulatory data submission registration/marketing authorization of human drugs for local manufacturing, import and export. The Licensing Operations of all [pharmaceutical and biological manufacturers are already enabled through the same plateform. This e-service is part of the transformation strategy of the Drug Regulatory Authority of Pakistan which aim 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 documents:
- Data Submission Format for Licensing Operation of Pharmaceutical Manufacturers
- Data Submission Format for Registration of Human Drugs
- Data Submission Format for Renewal of Registration of Human Drugs
- Data Submission Format for Variation in Registration of Human Drugs
The new e-service allows applicants to submit their data electronically through the eAPP portal, which is accessible 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 and will beWe 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. Thank you for your cooperation and support.
You can access the new e-service by clicking on this link: