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Stakeholders are invited to comment on Draft Guidelines on Emergency Use Authorization by 06th June, 2025

Mughees Mudassir Drugs, General

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

  1. Download the Draft Guideline: https://www.dra.gov.pk/wp-content/uploads/2025/05/DRAP-EUA-Guideline-2025.docx
  2. Submit Feedback: Email comments to muneeb.cheema∂drap.gov.pk by 06th June, 2025.

Deadline for Feedback: 06th June, 2025

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

Asad Ullah Drugs, Pharmacovigilance

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.

Implemenation letter of Industry e-reporting systemDownload

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

Asad Ullah Drugs

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.

CIRCULAR-SmPC-PILDownload

National Pharmacovigilance Cell (NPC), DRAP released draft Guidelines on National Pharmacovigilance System (Edition 03) seeking comments from stakeholders

Asad Ullah Drugs, General, Pharmacovigilance

The Drug Regulatory Authority of Pakistan (DRAP) has set up the National Pharmacovigilance Centre (NPC) in Islamabad to oversee the safety of medicinal products nationwide. The NPC collaborates with national and international entities to establish an effective pharmacovigilance system in Pakistan. Since 2018, Pakistan has been a full member of the World Health Organization Programme for International Drug Monitoring (WHO-PIDM) based at the Uppsala Monitoring Centre (UMC) in Sweden.

The NPC has developed a multi-channel reporting system, including electronic and manual reporting forms available through website and mobile applications for healthcare professionals and the public. The Pharmacovigilance Rules, 2022, apply a legal obligation of all pharmacovigilance stakeholders to establish their system and report the pharmacovigilance data to NPC.

The 1st edition of these guidelines was drafted as per the draft Pharmacovigilance Rules and had chapters and sections for the guidance of healthcare professionals, patients and registration holders. Subsequently, the National Pharmacovigilance Centre (NPC) issued separate guidelines for the above pharmacovigilance stakeholders and also Pharmacovigilance Rules, 2022 were officially notified vide S.R.O 540 (I)/2022 dated 22nd April 2022. Therefore, the NPC-issued 2nd edition of guidelines with the title “Guidelines on the National Pharmacovigilance System” which were prepared in line with Pharmacovigilance Rules, 2022. All those sections /chapters for the guidance of the above stakeholders were removed and the WHO PV indicators were incorporated in Chapter 11 in the 2nd edition of the guideline. This 3rd edition of these guidelines has been drafted in light of WHO recommendations in the form of Institutional Development Plans (IDP) made during its assessment of the National Regulatory System of the DRAP. As per WHO recommendation and DRAP’s Authority decision, the PRAEC has now been given an advisory role in relation to signal management and risk assessment; whereas, the NPC has been mandated to perform signal management and risk assessment process and to make decisions in the context of risk minimization and recommendation of regulatory actions to concerned Boards and Committees of the DRAP.

These guidelines are uploaded on the official website of DRAP on the 16th of September, 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 submitting comments, visit the DRAP website or click here. Comments and suggestions can be forwarded via email to pv∂dra.gov.pk or can be posted at the mailing address, Director, Division of Pharmacy Services, Drug Regulatory Authority of Pakistan, Prime Minister’s National Health Complex, Park Road, Islamabad.

NPVG-guidelines-reviewed-final-9-24-Draft-for-commentsDownload

Orientation Session For Pharmaceutical Manufacturers on PIC/s GMP Guidelines

Asad Ullah Drugs, General

The Drug Regulatory Authority of Pakistan (DRAP) is dedicated to enhancing the regulatory framework to meet international standards and elevate the pharmaceutical sector in Pakistan. As part of these efforts, DRAP is aspiring membership of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) for inspectorates in the field of Good Manufacturing Practice (GMP) of drug products.

 Pharmaceutical Inspection Co-operation Scheme (PIC/S)

PIC/S is a mutual cooperative arrangement between regulatory authorities in the field of GMP for medicinal products. PIC/S aims to harmonize inspection procedures globally by developing common standards in GMP and facilitating cooperation and networking between competent authorities, regional, and international organizations, thereby increasing mutual confidence.

Virtual Orientation Sessions

To raise awareness in the industry about the PIC/S theme and GMP guidelines, and to facilitate a phased transition towards adopting these guidelines, DRAP will conduct a series of virtual orientation sessions for pharmaceutical manufacturers. The tentative schedule for the first two sessions is as follows, with further sessions to be announced later:

SessionDate
Session 14th September, 2024
Session 26th September, 2024

Interested participants are required to complete the registration form by 31st August, 2024. The virtual session links will be emailed to registered participants with the session agenda.

PICs-GMP-Webinar-by-DRAPwith-revised-Reg-LinkDownload

DRAP Switched Over to Pakistan Single Window (PSW) for Regulatory Controls on Crossborder Trade at Karachi Custom Stations

Asad Ullah Drugs, General

The Drug Regulatory Authority of Pakistan (DRAP) is pleased to announce that, effective August 15, 2024, we have successfully transitioned from the Online Import Export System (OIES) to the Pakistan Single Window (PSW) for processing applications related to the clearance of commercial imports of raw materials and finished drug products at Karachi Seaport and Airport customs stations.

Pakistan Single Window (PSW) is an electronic portal enabling cross-border trade using standardized information and documents through a single entry point for all import, export, and transit-related regulatory requirements. The information is transmitted electronically, and individual data elements for clearance and regulatory approvals need only be submitted once. Authorized users who have completed the subscription process can access the PSW to perform cross-border procedures, including online payment/fees.

Key Highlights of the Transition:

  • Single Declaration Release: DRAP officers are now electronically issuing Release Orders through a Single Declaration (SD) system, streamlining the import/export process for pharmaceutical products.
  • Trade Automation: The new system allows for 24/7 electronic submission of cross-border trade applications, including online payment of fees and controlled data processing by authorized users.
  • Single Entry Point: Users can now submit standardized information and documents just once, simplifying the application process.
  • Clear Visibility and Application Tracking: The PSW system provides clear visibility of actions on applications, eliminating the need for physical visits for application follow-ups. It also allows for electronic calls on documents for any shortcomings.

DRAP Operations at PSW Include:

  • Entity Registration: Onboarding of existing Drug Manufacturing Licenses (DMLs), product registrations, and importers with existing drug sale licenses.
  • Raw Materials & Finished Drugs: Processing of drug import licenses (Form 5), clearance certificates for the import of raw materials, finished drugs, and controlled drugs.
  • Clinical Trials, Tests & Analysis: Issuance of drug import licenses for test analysis (Form 6) and clearance certificates for the import of drugs/medicines for clinical trials.
  • Hospital/Institutional Use & Donations: Import permits for unregistered/unavailable drugs and clearance certificates for donation medicines.

Additional Information:

  • DRAP Notification: DRAP has issued a notification regarding this transition to ensure all stakeholders are informed and prepared for the new process.
  • PSW User Manual: PSW has issued a comprehensive user manual to guide users through the new system, ensuring a smooth and efficient transition.

For further assistance, please contact us at 021-111-111-779 or email support∂psw.gov.pk.

DRAP-Phase-1-on-PSWDownload