Important Notice to INGOs, NGOs, Hospitals and Government Programs/Departments Importers of Donated Drugs in Pakistan

The Drug Regulatory Authority of Pakistan (DRAP) and the Pakistan Single Window (PSW) have implemented an automated clearance system for the importation of donated drugs in Pakistan. This system aims to optimize and expedite the efficiency of the pharmaceutical supply chain in Pakistan and ensure a seamless and transparent delivery of donated drugs.

PSW Subscription Required for Donated Drugs Importation in Pakistan

To participate in this system, all registered International Non-Governmental Organizations (INGOs), Donor Partners, Local NGOs/Hospitals, and Government Projects involved in donated drugs importation need to acquire their PSW Subscription promptly.

The PSW Subscription is a pivotal step in ensuring a smooth and sustainable pharmaceutical supply chain in Pakistan. Your subscription significantly contributes to the optimization of drug distribution, allowing us to collectively make a more substantial impact on public health.

How to Subscribe in 6 Easy Steps:

  • Visit the PSW website to access detailed instructions, user manuals, and demo videos.
  • Follow the straightforward subscription process and complete your subscription efficiently.
  • If you have any questions or require assistance during the subscription process, contact the PSW Support team at 021-111-111-779 or reach out via email at supportpsw.gov.pk.

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 2022 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

DRAP invites all interested parties, including sponsors, investigators, ethics committees, contract research organizations, and other relevant entities, to provide their comments and inputs on the revision of the guideline. 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.hussaindra.gov.pk with copy to dir.psdra.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.


DRAP invited Stakeholders Comments on revision of Guidelines on Recall of Defective Therapeutic Goods

The Drug Regulatory Authority of Pakistan (DRAP) is revising the Guidelines on Recalls and Rapid Alerts of Defective Therapeutic Goods, which were first published in 2021. The revision is based on the feedback from stakeholders and the recommendations from the World Health Organization (WHO).

The guidelines provide a comprehensive framework for reporting, investigating, and recalling suspected defective therapeutic goods products and applies to the therapeutic goods industry and supply chain, healthcare professionals, patients, sponsors of clinical trials, and regulatory staff. The guidelines aim to provide recommendations and explain the procedures to be adopted by the DRAP and the Pharmaceutical Industry for the effective removal of defective therapeutic goods from the market that may cause harm to the consumer and to safeguard public health.

By adhering to these guidelines, the licensees and the DRAP can ensure a timely, coordinated, and transparent response to any defective therapeutic goods incidents, and thus protect the health and safety of the public and the animals.

The main objectives of the revision are to:

  • Update the procedures for recalls and related actions for defective therapeutic goods
  • Adopt a uniform and consistent approach to conducting recalls in Pakistan
  • Incorporate the best practices and lessons learned from the consultative workshop on recalls and rapid alerts held by DRAP
  • Enhance the communication and coordination among the manufacturers, importers, suppliers, and DRAP in conducting recalls
  • Strengthen the monitoring and evaluation of the recall outcomes and follow-up actions

We invite all stakeholders to review the draft revised guidelines and provide us with your comments and suggestions . This draft guideline is available for comments from 21-02-2024. 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 sanaullah.babardra.gov.pk with copy to mahvash.ansaridra.gov.pk or can be posted at following mailing address: Deputy Director, Quality Assurance & Laboratory Testing, Drug Regulatory Authority of Pakistan, 3rd floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad.

Stakeholders are invited to submit their comments on Draft Guidance on Establishment of Pharmaceutical Unit and Post License Changes (2nd edition)

The Drug Regulatory Authority of Pakistan (DRAP) is inviting stakeholder comments on the revised guidance document: “Establishment of Pharmaceutical Unit and Post License Changes”. This document aims to simplify and clarify the regulatory procedures for applicants and firms seeking to acquire, renew, or modify their Drug Manufacturing Licenses (DMLs).

Features of Revised Edition of the Guidance Document

This document provides a clear and concise overview of the entire licensing process, from initial application to post-license modifications.

The guidance document outlines the steps involved in obtaining a DML, including site selection, application forms, fee payment, and inspections. This aims to make the process more efficient and transparent for applicants.

Who Benefits

Applicants: This guideline serves as a valuable resource for pharmaceutical companies, entrepreneurs, and individuals seeking to establish or expand their drug manufacturing operations in Pakistan.

Firms: Existing DML holders can utilize this document to understand their responsibilities and procedures for post-license changes and renewals.

Investors: The streamlined process outlined in the guideline can create a more attractive investment climate for the pharmaceutical industry in Pakistan.

To access the full DRAP guidance document, please Click on “Establishment of Pharmaceutical Unit and Post License Changes”.

The revised guidelines are open for public comments until March 7, 2024. DRAP invites all the relevant stakeholders, such as pharmaceutical companies 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 dir.licdra.gov.pk or can be posted at mailing address, Director, Division of Drug Licensing, 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.

DRAP added New features in eAPP system enabling Online Submission for all types of Registration Applications of Drug Products

The Drug Regulatory Authority of Pakistan (DRAP) added a new e-service for online regulatory data submission for registration/marketing authorization of human drugs for local manufacturing, import and export. This e-service complements the existing one for licensing operations of all pharmaceutical and biological manufacturers, which are both accessible through the same platform. This e-service is part of the transformation strategy of the Drug Regulatory Authority of Pakistan, which aims to ensure the quality, safety and efficacy of therapeutic goods in Pakistan.

The e-service requires applicants to submit their data in a standardized format, as specified in the following type of submission:

  • Registration of Drugs on Form-5F for human Use.
  • Registration of Drugs on Form-5 & Form 5A for Veterinary Use.
  • Application for Post Registration Variations.
  • Renewal for Registration of Drugs

The new e-service allows applicants to submit their data electronically through the eAPP portal, which can be accessed after registering an account with DRAP. The e-service offers several benefits, such as:

  • Faster and easier data submission and processing
  • Reduced paper work and redundancy
  • Increased transparency and visibility

This new e-service will facilitate the licensing and registration process and improve the regulatory system in Pakistan. DRAP will reach out to applicants in assisting application submission on this new eService.

We welcome your feedback and suggestions on how to improve our services. Please contact us at infodra.gov.pk or +92 51 9260 500 for any queries or assistance.

We hope that these new features will further enhance the efficiency and convenience of our e-service and facilitate the development and availability of quality therapeutic goods in Pakistan.

Stakeholders Comments are invited on revision of Guidelines on Conduct of Clinical Trials 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 February 22, 2024. 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.hussaindra.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.


Registration Board Direction; Procedure for Capacity Assessment of the Contract Acceptor

Registration Board in its 333rd meeting held on 19th – 20th December, 2023 discussed the subject mentioned case and decided as under: –

1.         Inspection of contract accepter for manufacturing / testing capacity assessment shall be conducted for all those contract manufacturers, who has not been inspected for such purpose with in the last 3 years. The panel shall verify capacity assessment of all those sections, which are approved by the Licensing Division.

2.         Capacity assessment of newly applied facility (Section) shall not be carried out, if any section of that manufacturing facility has already been assessed within last three years.

3.         Following shall be prerequisites for submission of application for contract manufacturing under Rule 20(A) of Contract Manufacturing Policy.

a.         Affidavit on stamp paper (Showing name, designation, CNIC Number of contract giver) stating installed capacity of the contract accepter for contract manufacturing. This affidavit shall only be signed by the CEO / MD of the firm. i.e. contract accepter.

b.         Copy of DML of both firms. i.e. contract giver and contract accepter along with Section (s) approval from Licensing Division.

c.         Valid GMP certificate or GMP inspection report of the contract accepter, conducted within last three years.

d.         Copy of legalized contract between contract giver and contract accepter on stamp paper presenting the capacities of the contract accepter for the manufacturing sections for whom the products have been applied, and

4.         Affidavits submitted by the contract accepter, showing manufacturing / testing capacity, will be verified in the subsequent inspections conducted for GMP / renewal of DML and will be reported accordingly. Chairman, Registration Board may constitute panel of experts to verify capacity assessment, if required.

5.         The capacity verification report will be valid for 3 years.

DRAP invites Comments on Draft Guideline for Storage and Destruction of Substandard-Falsified (SF )and recalled Therapeutic Goods

The Drug Regulatory Authority of Pakistan (DRAP) has drafted a guideline on the storage and destruction of recalled therapeutic goods, which are medicines, medical devices, and health products that do not meet the quality standards or are deliberately misrepresented. The guideline aims to provide a framework for the safe and effective management of such goods, from their identification and reporting to their disposal and documentation.

The draft guideline covers the following aspects:

  • The roles and responsibilities of different stakeholders, such as manufacturers, importers, distributors, health care providers, and regulators, in handling substandard and falsified as well as recalled therapeutic goods.
  • The criteria for selecting suitable storage facilities and methods for defective therapeutic goods.
  • The methods for destroying in an environmentally sound manner.
  • The records and reports that need to be maintained and submitted.

The draft guideline is available on the DRAP website on 27th October, 2023 for public consultation. DRAP invites comments and feedback from all stakeholders, including the pharmaceutical industry, health professionals, civil society organizations, and the general public. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using prescribed format. For further guidelines on how to submit comments visit DRAP website or click here. Comments and suggestions can be forwarded via email to ajmal.sohaildra.gov.pk, copying at sanaullah.babardra.gov.pk, or can be posted at mailing address, Director, Quality Assurance & Lab Testing, Drug Regulatory Authority of Pakistan, 3rd floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.

DRAP appreciates the cooperation and participation of all stakeholders in ensuring the quality, safety, and efficacy of therapeutic goods in Pakistan.

DRAP Added New eService for Online Data Submission for Registration of Pharmaceutical and Biological Product

The Drug Regulatory Authority of Pakistan (DRAP) is pleased to announce the addition of a new e-service for online regulatory data submission registration/marketing authorization of human drugs for local manufacturing, import and export. The Licensing Operations of all [pharmaceutical and biological manufacturers are already enabled through the same plateform. This e-service is part of the transformation strategy of the Drug Regulatory Authority of Pakistan which aim to ensure the quality, safety and efficacy of therapeutic goods in Pakistan.

The e-service requires applicants to submit their data in a standardized format, as specified in the following documents:

  • Data Submission Format for Licensing Operation of Pharmaceutical Manufacturers
  • Data Submission Format for Registration of Human Drugs
  • Data Submission Format for Renewal of Registration of Human Drugs
  • Data Submission Format for Variation in Registration of Human Drugs

The new e-service allows applicants to submit their data electronically through the eAPP portal, which is accessible after registering an account with DRAP. The e-service offers several benefits, such as:

-Faster and easier data submission and processing.
-Reduced paper work and redundancy

-Increased transparency and visibility

This new e-service will facilitate the licensing and registration process and improve the regulatory system in Pakistan. DRAP will reach out to applicants in assisting application submission on this new eService and will beWe welcome your feedback and suggestions on how to improve our services. Please contact us at infodra.gov.pk or +92 51 9260 500 for any queries or assistance. Thank you for your cooperation and support.

You can access the new e-service by clicking on this link: