Stakeholders are invited to submit their comments on Draft Guidance on Establishment of Pharmaceutical Unit and Post License Changes (2nd edition)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