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Stakeholders Comments are invited on Draft Guidelines On Submission of Expenditure Details Under the Ethical Marketing To Healthcare Professionals Rules, 2021

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The Healthcare Industry, comprising various sectors, is interlinked and highly dependent on frequent interactions, coordination, and supportive activities for a sustainable healthcare environment. Among this industry, therapeutic goods establishments and healthcare professionals are two important stakeholders and their interaction is vital and prone to criticism due to its repercussions on patients and the public.

To ensure innovation, progress, and improvement in healthcare and healthcare products while preserving professional ethics and transparency, the Drug Regulatory Authority of Pakistan (DRAP) has taken significant steps in line with the provision of Section 7(q) of the DRAP ACT 2012, which mandated the Authority to monitor and regulate marketing practices to ensure the rational use of drugs and ethical criteria for the promotion of therapeutic goods in line with international practices. In exercising this function, DRAP has notified the “Ethical Marketing to Healthcare Professionals Rules 2021” via S.R.O. 1472(I)/2021 on the 12th of November 2021. These rules outline the major forms of interaction between companies and healthcare professionals.

To facilitate the implementation, DRAP has developed a draft guideline on submitting expenditure details related to marketing activities targeted towards healthcare professionals to provide clarity and ensure compliance with the Ethical Marketing to Healthcare Professionals Rules 2021.

These guidelines are uploaded on the official website of DRAP on the 9th of August, 2024 to seek comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using the prescribed format. For further guidelines on how to submit comments visit the DRAP website or click here. Comments and suggestions can be forwarded via email to aqsa.hashmi∂dra.gov.pk or can be posted at the mailing address, Director, Division of Pharmacy Services, Drug Regulatory Authority of Pakistan, Prime Minister National Health Complex, Park Road, Chak Shehzad, Islamabad.

DRAFT Guidelines on Data Submission under Ethical Marketing RulesDownload

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