Implemmentation of Industry E-Reporting System for Reporting of Adverse Drug Reactions by Registrtaion Holders

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.

Directive of Registartion Board; Submission of Summary of Product Characteristics (SmPC), Prescribing Information(PI) and Patinet Leaflet(PIL)

Registration Board in 340th meeting held from 1st October to 2nd October 2024, directed applicants to submit the Summary of Product Characteristics (SmPC) including Prescribing Information (PI) along with Patient Information Leaflet (PIL) against section 1.5.14 of CTD for the Finished Pharmaceuticals Product (FPP).

It is hereby circulated for compliance and information of all stakeholders.

Career Opportunities: Applications are invited for Various Positions in DRAP

The Drug Regulatory Authority of Pakistan (DRAP) employs over 500 people from a range of educational backgrounds, who have the skills and experience to perform regulatory operational services under the DRAP Act 2012. These include professionals both technical (qualifications in medicine and pharmacy-related sciences, etc.) and non-technical (qualifications in law, information and communication technology, accounts, human resources management, etc.)

DRAP is mandated to provide effective coordination and enforcement of The Drugs Act, 1976, and harmonization of inter-provincial trade and commerce of therapeutic goods. Being the national regulatory body for therapeutic goods, DRAP performs various regulatory functions of therapeutic goods including licensing of establishments, product registrations/marketing authorizations, pharmacovigilance, post-market surveillance and market control, regulatory inspections, laboratory testing, clinical trials oversight and lot release of biologicals.

Details of Vacant Positions advertised are as below.

Provincial Workshop – Implementation of IDPs for Cross-Cutting Regulatory Functions to Strengthen National Regulatory System of Pakistan held on 21-22 October, 2024 at Lahore

Provincial Workshop – Implementation of IDPs for Cross-Cutting Regulatory Functions to Strengthen National Regulatory System of Pakistan held on 21-22 October, 2024 at Lahore

Lahore – October 21-22, 2024: The Drug Regulatory Authority of Pakistan (DRAP), in collaboration with the World Health Organization (WHO) Pakistan, hosted a provincial workshop on the implementation of Institutional Developmental Plans (IDPs) aimed at strengthening the National Regulatory System of Pakistan based on WHO recommendations.

Mr. Nadeem Mahbub, Federal Secretary of the Ministry of National Health Services, Regulation & Coordination, and Ms. Ellen Mpangananji Thom, Officer Incharge, WHO Office in Pakistan participated in this workshop.

Mr. Asim Rauf, CEO DRAP briefed the participants on the roadmap for strengthening the regulatory system of Pakistan.

This interprovincial coordination workshop was attended by key officials, including the Director General of Provincial Drug Control Administrations, the Chief Inspector of Drugs from all federating units, Directors of National Quality Control Laboratories (CDL and DTLs), officers from provincial regulatory institutions, and teams from DRAP working on the implementation of the Institutional Developmental Plans (IDPs) based on the WHO Global Benchmarking Tool for National Regulatory Authorities.

This 02-day workshop provided the opportunities to strengthen the regulatory framework in all federating units by developing collaborative working procedures in various areas including pharmacovigilance, Market Surveillance, Licensing, Inspection, Laboratory Testing and Quality Management System.