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Pakistan's DRAP Launches E-Reporting System for Drug Adverse Reactions

  • The Drug Regulatory Authority of Pakistan (DRAP) is launching a mandatory e-Reporting System for pharmaceutical companies to report adverse drug reactions, effective November 8, 2024.
  • Developed with the Uppsala Monitoring Centre, the system streamlines the submission process for manufacturers and importers of therapeutic goods via E2B XML or manual data entry.
  • The National Pharmacovigilance Centre (NPC) will oversee the initiative to ensure therapeutic product safety, adhering to the Pharmacovigilance Rules, 2022.
  • DRAP aims to enhance transparency and efficiency in document submission, providing secure system access and comprehensive guidelines to all registration holders.
The Drug Regulatory Authority of Pakistan (DRAP) has announced the implementation of a new Industry e-Reporting System designed to monitor and manage adverse drug reactions more effectively. Set to become mandatory on November 8, 2024, the system will require all registered pharmaceutical companies to report adverse drug reactions through the platform.
The announcement, addressed to key stakeholders including the Pakistan Pharmaceutical Manufacturing Association (PPMA), Pharma Bureau, and Pakistan Chemist and Druggist Association (PCDA), follows a successful pilot project involving selected registration holders. The e-Reporting System was developed in collaboration with the Uppsala Monitoring Centre, aiming to simplify the reporting process for manufacturers and importers of therapeutic goods.
The National Pharmacovigilance Centre (NPC), operating under the Division of Pharmacy Services, will supervise the new system. This oversight is intended to ensure the safety of therapeutic products in Pakistan, in accordance with the Pharmacovigilance Rules, 2022. The system is designed to accept Individual Case Safety Reports (ICSRs) through two modules: E2B XML submission for companies equipped for it and manual data entry for those without E2B XML capabilities.
DRAP has stated that the launch of this system 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 expressed gratitude to stakeholders for their cooperation in ensuring the safety and efficacy of therapeutic products within Pakistan.
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Reference News

[1]
DRAP launches industry e-reporting system to monitor drug reaction - Dental News
dentalnews.pk · Nov 5, 2024

DRAP launches Industry e-Reporting System for mandatory adverse drug reaction reporting from Nov 8, 2024, developed with...

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