Regulatory Updates
Stakeholders are invited to comment on Draft Guidelines on Emergency Use Authorization by 06th June, 2025
Draft Guidelines on Emergency Use Authorization
The Drug Regulatory Authority of Pakistan (DRAP) has developed a draft guideline outlining the regulatory framework for granting Emergency Use Authorization (EUA) of medicinal products during a declared Public Health Emergency (PHE). This guideline aims to facilitate timely access to critical medicines, vaccines, or diagnostics when no approved alternatives are available, ensuring public health protection while maintaining rigorous safety and efficacy standards.
Key Highlights of the EUA Guideline
- Legal Basis: EUA is granted under the Drugs Act, 1976 and Drug (Licensing, Registering & Advertising) Rules, 1976, empowering DRAP to authorize unregistered products during emergencies.
- Risk-Benefit Assessment: Authorization considers whether the potential benefits outweigh risks in diagnosing, treating, or preventing life-threatening conditions.
- Scope: Applies to emergencies involving threats to public health, safety, or national security (e.g., pandemics, bioterrorism).
- Alignment with Existing Guidelines: Should be read alongside DRAP’s Guidance Documents for Registration of Pharmaceutical & Biological Products.
Call for Stakeholder Input
DRAP invites healthcare professionals, pharmaceutical manufacturers, researchers, policymakers, and the public to review the draft guideline and provide constructive feedback. Your expertise will ensure the framework is robust, transparent, and aligned with international best practices.
How to Submit Comments
- Download the Draft Guideline: https://www.dra.gov.pk/wp-content/uploads/2025/05/DRAP-EUA-Guideline-2025.docx
- Submit Feedback: Email comments to muneeb.cheema∂drap.gov.pk by 06th June, 2025.
Deadline for Feedback: 06th June, 2025
Training Session on MDMC Licensing and Product Registration Portal on: https://www.facebook.com/OfficialDRAP/
Comments are invited on revision of Guidelines on Inspection of Good Clinical Practices for Clinical Trials
The Drug Regulatory Authority of Pakistan (DRAP) is planning to revise its guideline for the conduct of Good Clinical Practice (GCP) inspection and reporting. The current guideline was issued in Maech-2024 and provides the procedure and criteria for GCP inspections of clinical trials regulated by DRAP.
The revision aims to update the guideline in accordance with the latest international standards and best practices, as well as to address the feedback and suggestions received from the stakeholders. The revised guideline will cover the following aspects:
- The objectives and scope of GCP inspections
- The preparation and planning of GCP inspections
- The conduct and documentation of GCP inspections
- The follow-up and closure of GCP inspections
The revised guidelines are open for public comments until June 05, 2025. DRAP invites all the relevant stakeholders, such as pharmaceutical companies, research institutions, clinical trial organizations, health professionals, patient groups, and civil society organizations, to review the revised guidelines and provide their feedback and suggestions. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using prescribed format, (further information on comments submission can access on this link. Comments and suggestions can be forwarded via email to shafqat.hussain∂dra.gov.pk with copy to dir.ps∂dra.gov.pk or can be posted at following mailing address: Assistant Director (Clinical Research), Pharmacy Services Division, Drug Regulatory Authority of Pakistan, DRAP-NCLB Building, Prime Minister’s Health Complex, Park Road, Chak Shahzad, Islamabad, Pakistan. DRAP appreciates your participation and contribution to this consultation process. Your comments and inputs will help us to improve the quality and effectiveness of our GCP inspection and reporting system
Stakeholders Comments are invited on revision of Guidelines for Conduct of Clinical Research in Pakistan
The Drug Regulatory Authority of Pakistan (DRAP) is revising Guidelines on Conduct of Clinical Trials in Pakistan with the aim to ensure the safety, quality, and efficacy of investigational products in clinical trials, as well as the ethical conduct and oversight of clinical research in Pakistan.
The revised guidelines cover various aspects of clinical trial activities, such as:
- The regulatory framework and approval process for clinical trials in Pakistan
- The roles and responsibilities of various stakeholders involved in clinical trial activities, such as DRAP, National Bio Ethics Committee, sponsors, investigators, and pharmaceutical associations
- The requirements and procedures for obtaining informed consent, protecting the rights and welfare of trial participants, and reporting adverse events and serious adverse events
- The standards and principles for designing, conducting, monitoring, recording, analyzing, and reporting clinical trials
- The good clinical practice (GCP) requirements for clinical trial materials and investigational products
- The data management and quality assurance systems for clinical trial data and documents
- The post-trial obligations and follow-up measures for clinical trial sponsors and investigators
The revised guidelines are based on the best regulatory practices as per the International Council for Harmonisation (ICH) guidelines, and the World Health Organization (WHO) guidelines.
The revised guidelines are open for public comments until June 05, 2025. DRAP invites all the relevant stakeholders, such as pharmaceutical companies, research institutions, clinical trial organizations, health professionals, patient groups, and civil society organizations, to review the revised guidelines and provide their feedback and suggestions. Stakeholders can submit their comments and suggestions using prescribed format (click here to visit how to submit comments) via email to shafqat.hussain∂dra.gov.pk or can be posted at mailing address, Director, Division of Pharmacy Services, Drug Regulatory Authority of Pakistan, PM health Complex, Park Road, Islamabad.
DRAP appreciates the cooperation and contribution of all the stakeholders in the development and improvement of the guidelines on conduct of clinical trials in Pakistan. DRAP hopes that the revised guidelines will facilitate and promote the conduct of high-quality, ethical, and reliable clinical trials in Pakistan, and ultimately benefit the public health and well-being of the people of Pakistan.