ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) has announced the launch of the Industry e-Reporting System, a new platform for reporting adverse drug reactions, set to be mandatory from November 8, 2024, for all registered pharmaceutical companies.
In a statement addressed to the heads of the Pakistan Pharmaceutical Manufacturing Association (PPMA), Pharma Bureau, and Pakistan Chemist and Druggist Association (PCDA), DRAP said the system follows a successful pilot project with selected registration holders.
Developed in collaboration with the Uppsala Monitoring Centre, the platform will simplify the submission process for manufacturers and importers of therapeutic goods.
The National Pharmacovigilance Centre (NPC), operating under the Division of Pharmacy Services, will supervise the initiative to ensure therapeutic product safety in compliance with the Pharmacovigilance Rules, 2022.
DRAP has designed the system to accept Individual Case Safety Reports (ICSRs) through two modules: E2B XML submission for companies equipped for it, and manual data entry for those not using E2B XML.
With the launch of this system, DRAP reaffirms its commitment to promoting transparency and facilitating efficient document submission.
Comprehensive guidelines are available on DRAP’s official website, and each registration holder will receive secure system access with two accounts.
DRAP has thanked stakeholders for their cooperation in ensuring the safety and efficacy of therapeutic products in Pakistan.
