Guidelines
Guidelines on Post License Variations (For Comments)
The Drug Regulatory Authority of Pakistan has revised and updated the requirements for grant of Drug manufacturing license and Post Licnese variations, in line with DRAP Act 2012, Drug Act 1976 and rules framed there under after adaptation of PIC/s Guidelines.
These requirements serve a reference document for the applicants intended to apply for grant of Drug Manufacturing Licenses and Post License variation .The requirements aim to facilitate harmonization with international regulatory requirements, enabling Pakistani manufacturers to meet the stringent standards required by international regulatory bodies and foreign regulatory authorities.
Accordingly, the 4th version of guidance document titled “ESTABLISHMENT OF PHARMACEUTICAL UNIT, GRANT AND RENEWAL OF DML-THEREOF, and 1st version of “POST LICENSE VARIATIONS “along with newly drafted ANNEXURES are uploaded on the official website of DRAP on the 30th of September , 2026 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 abdullah.diyo∂dra.gov.pk and drapakbar∂gmail.com , zunairafaryad∂gmail.com or can be posted at the mailing address, Director, Division of Drug Licensing , Drug Regulatory Authority of Pakistan, Prime Minister’s National Health Complex, Park Road, Islamabad.
Establishment of Pharmaceutical Unit and Post License Changes(For Comments)
The Drug Regulatory Authority of Pakistan has revised and updated the requirements for grant of Drug manufacturing license and Post Licnese variations, in line with DRAP Act 2012, Drug Act 1976 and rules framed there under after adaptation of PIC/s Guidelines.
These requirements serve a reference document for the applicants intended to apply for grant of Drug Manufacturing Licenses and Post License variation .The requirements aim to facilitate harmonization with international regulatory requirements, enabling Pakistani manufacturers to meet the stringent standards required by international regulatory bodies and foreign regulatory authorities.
Accordingly, the 4th version of guidance document titled “ESTABLISHMENT OF PHARMACEUTICAL UNIT, GRANT AND RENEWAL OF DML-THEREOF, and 1st version of “POST LICENSE VARIATIONS “along with newly drafted ANNEXURES are uploaded on the official website of DRAP on the 30th of September , 2026 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 abdullah.diyo∂dra.gov.pk and drapakbar∂gmail.com , zunairafaryad∂gmail.com or can be posted at the mailing address, Director, Division of Drug Licensing , Drug Regulatory Authority of Pakistan, Prime Minister’s National Health Complex, Park Road, Islamabad.
Guidance on the Registration Pathways for Pharmaceutical and Biological Drugs for Human Use
Post-Registration Variation Guidelines for Pharmaceutical and Biological Products
Public Consultation: Guidance Document for Submission of Application on Form-5F (CTD) for Registration of Biological Products for Human Use – 2nd Edition.
The Drug Regulatory Authority of Pakistan (DRAP), Division of Biological Evaluation & Research, invites public comments on the draft “Guidance Document for Submission of Application on Form-5F (CTD) for Registration of Biological Products for Human Use – 2nd Edition.”
This updated guidance aims to enhance clarity, align regulatory requirements with international standards, and introduce specific provisions for biosimilars, bulk/ready-to-fill biologicals, pharmacovigilance, stability, and comparability requirements. The document is intended to facilitate consistent, transparent, and efficient submission and review of registration applications for biological products.
Stakeholders, including manufacturers, importers, healthcare professionals, academia, and the general public, are encouraged to review the draft and submit written comments, suggestions, or technical inputs at muneeb.cheema∂dra.gov.pk or muneebcheema∂hotmail.com within fifteen days of uploading of above document.
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.lic∂dra.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.
Stakeholders’ Comments are invited on the Draft Guidelines on Patient Information Leaflet
The Patient Information Leaflet (PIL) provides essential information to patients and caregivers on the use of drug products ensuring their safety, efficacy, and quality. It describes the information for patients that ensures the safe and effective use of medicine under most circumstances. The PIL is a document that is updated as new data emerges related to drug product safety, efficacy, and quality or use. The registration/market authorization holder is responsible shall supply any new information without delay which may require the variation of the marketing authorization/registration including the revision of PIL.
The guideline is intended to provide supportive information for preparing a Patient Information Leaflet (PIL) for registration/market authorization of pharmaceutical and biological products of all types including New drug products, Generic drug products, and Biosimilars. This guideline provides advice on the principles of presenting information in the PIL.
This draft guideline is uploaded on the official website of DRAP dated 5th May 2023, for seeking 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 DRAP website or click here. Comments and suggestions can be emailed to haseeb.tariq∂dra.gov.pk, copied at addl-dir.pe.reg∂dra.gov.pk, or posted at the mailing address, Director, Pharmaceutical Evaluation & Registration, Drug Regulatory Authority of Pakistan, 4th-floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.
Stakeholders Comments are invited on the Draft Guidelines for Good Cold Chain Management Practices for Temperature-Sensitive Drug Products
The supply chain of Time and Temperature Sensitive Drug Products (TTSDPs) requires constant maintenance of temperature so that the cold chain remains integral to ensure that the product quality is not compromised. Registration holders of TTSDPs including manufacturers, Importers and exporters along with their authorized distributors, are required to provide suitable storage conditions throughout the life cycle of the product under the Drugs (Licensing, Registering & Advertising) Rules, 1976. Similarly, Pharmacies, Medical stores and other authorized sale outlets, and healthcare institutions are also required to provide suitable storage and distribution while dispensing TTSDPs under relevant provincial drug sale rules.
DRAP has drafted this guidelines to set out the principal requirements for the safe storage and distribution of time- and temperature-sensitive pharmaceutical products (TTSDPs). These guidelines intended to emphasize the increased importance of pharmaceutical cold chain management as a result of changing product environment, the requirements for Good Storage and Distribution Practices, current regulatory trends, quality management, risk assessment factors, and temperature monitoring system.
This draft guideline is uploaded on the official website of DRAP dated on 27th March, 2023, for seeking comments and suggestions from stakeholders on the draft document. 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.sohail∂dra.gov.pk, copying at akbar.ali∂dra.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.
Notification: Directions of Registration Board on Reference Product data submissions for conducting Pharmaceutical Equivalence and Comparative Dissolution Profile Studies
Registration Board of DRAP has issued a Guidance document for applicants on submission of application on form 5-F (CTD) for registration of pharmaceutical drug products for human use. Submission of data of pharmaceutical equivalence and Comparative Dissolution Profile (CDP) is required under section 3.2.P.2.2.1 (Formulation Development) of Form 5F (CTD).
In order to further harmonize the submission of such data and ensure data integrity, Registration Board in its 322nd meeting held on 8th & 10th November, 2022 decided as under:
“Firm shall submit the image/picture/snapshot of the innovator/reference/comparator pack against which Pharmaceutical equivalence / Comparative Dissolution Profile studies have been performed and shall reveal the details of brand name, manufacturer, batch# and expiry date of the innovator/reference/comparator product in the section 3.2.P.2.2.1 (Formulation development) of Form 5F.“
Accordingly, above decision of Registration Board is hereby notified and circulated for information and compliance by relevant stakeholders / applicants.