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Month: July 2024

DRAP Pharmacovigilance Newsletter-August 2024

Asad Ullah Pharmacovigilance

The National Pharmacovigilance Centre (NPC), Division of Pharmacy Services, Drug Regulatory Authority of Pakistan (DRAP) is excited to announce the release of the new edition of its Pharmacovigilance Newsletter!

This edition is filled with essential updates and insights for healthcare professionals, regulators, and registration holders. Key highlights include:

  • Launching of VigiMobile App in Urdu 
  • Strengthening Pharmacovigilance Systems in Public Health Programmes 
  • Pharmacovigilance Training Sessions for Healthcare Professionals
  • Highlights from the 4th Meeting of the Pharmacovigilance Risk Assessment Expert Committee (PRAEC) 
  • Latest Safety Alerts 

Stay informed and enhance your knowledge of medication safety to help minimize medication harm and ensure better patient outcomes

NPC Newsletter_July24 Final (RS)Download

Webinar on Building Effective Medicine Pricing Policies for Low- and Middle-Income Countries

Asad Ullah Events
Webinar on Building Effective Medicine Pricing Policies for Low- and Middle-Income Countries

The Drug Regulatory Authority of Pakistan held an insightful discussion on “Building Effective Medicine Pricing Policies for Low and Middle-Income Countries on Tuesday July 23, 2024 at 10:00 AM at DRAP HQ, Islamabad. The session was led by Prof. Zaheer-Ud-Din Babar, University of Huddersfield and Editor-in-Chief of the Journal of Pharmaceutical Policy and Practice. Senior management of the DRAP attended the session at DRAP HQ, Islamabad, while more than 100 colleagues from industry and academia participated in the session virtually.

The discussion among participants centered on evidence-based challenges and potential solutions for medicinal pricing policies, tailored to the specific needs of low and middle-income countries. It included an analysis of five distinct pharmaceutical pricing strategies and the primary enablers for developing effective policies.



In case you missed the live session, the webinar recording is available at the following link.

Bioequivalence and Bioavailability of Drug Products

Asad Ullah Drugs

The Drug Regulatory Authority of Pakistan (DRAP) is committed to ensure that all pharmaceutical drug products shall conform to acceptable standards of safety, efficacy and quality. The submission of bioequivalence studies is requirement of Form-5F (Common Technical Document) notified vide SRO 713(1)/2018 dated 08.06.2018.

The Registration Board, in its 338th meeting on July 4, 2024, resolved that the regulatory approval process for the registration of generic drugs in light of the guidelines of international regulatory agencies will include the implementation of Bio-equivalence studies in adherence to WHO guidelines. The decision of the Registration Board is hereby communicated for implementation.

Bioavailability-Bioequivalence-StudiesDownload