The Drug Regulatory Authority of Pakistan (DRAP) has launch the Industry e-reporting System for Individual Case Safety Reports (ICSRs). This new system, developed in collaboration with the Uppsala Monitoring Centre (UMC), aims to simplify and streamline the submission process for registration holders, including manufacturers and importers of therapeutic goods. The National Pharmacovigilance Centre (NPC), established under the Division of Pharmacy Services, will oversee this initiative to ensure the safety of therapeutic goods, in line with the Pharmacovigilance Rules, 2022.
Since its inception, DRAP has been committed to promoting transparency and facilitating document submission through various tools. The new Industry e-Reporting System will allow registration holders to submit ICSRs via two modules: E2B XML submission and manual data entry for non-E2B pharmaceutical companies. Access to this system will be secure, with two accounts provided per registration holder.
Following a successful pilot project with a selected number of registration holders, DRAP is now extending the system’s scope to all registration holders. Starting from 8th November 2024, all future ICSRs must be submitted through this system. For further guidelines, please refer to the “Industry e-Reporting Manual for Registration Holders” available on the DRAP website.
We appreciate your cooperation in ensuring the safety and efficacy of therapeutic goods in Pakistan.