Adverse drug reactions: DRAP implements ‘Industry e-Reporting System’

ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) has officially announced implementation of Industry e-Reporting System for reporting of adverse drug reactions.

In an official communique directed to the chairman Pakistan Pharmaceutical Manufacturing Association (PPMA), the executive director (ED) Pharma Bureau and the chairman Pakistan Chemist and Druggist Association (PCDA), the DRAP said, following the completion of a successful pilot project on the subject engaging a selected group of registration holders has decided to extend its scope to all the registration holders.

Therefore, all the registration holders are hereby directed to submit all future Individual Case Safety Reports (ICSRs) only through the Industry e-Reporting System with effect from November 8, 2024.

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, the 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, the 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. Further guidelines are available on the DRAP’s website.

The DRAP will appreciate your cooperation in ensuring the safety and efficacy of therapeutic goods in Pakistan.

Copyright Business Recorder, 2024