Author: Mughees Mudassir
Decisions of 88th Meeting of the Medical Device Board
Decisions of 87th Meeting of the Medical Device Board
Decisions of 86th Meeting of the Medical Device Board
Decisions of 85th Meeting of the Medical Device Board
Decisions of 78th Meeting of the Medical Device Board
Decisions of 67th Meeting of Medical Device Board (Deficiency letter for Medical Devices Applications)
The Medical Device Board (MDB) of the Drug Regulatory Authority of Pakistan in 67th meeting has deferred the following applications of registration/enlistment of medical devices due to various deficiencies/shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information/documentation as directed by the Medical Device Board. The detail is provided in the below attachment
Decisions of 66th Meeting of Medical Device Board (Deficiency letter for Medical Devices Applications)
The Medical Device Board (MDB) of the Drug Regulatory Authority of Pakistan in 66th meeting has deferred the following applications of registration/enlistment of medical devices due to various deficiencies/shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information/documentation as directed by the Medical Device Board. The detail is provided in the below attachment
DRAP Releases 2nd Edition of Guidelines for Good Clinical Practice (GCP) Inspections
The Drug Regulatory Authority of Pakistan (DRAP) is pleased to announce the release of the second edition of the “GUIDELINES FOR CONDUCT AND REPORTING OF GOOD CLINICAL PRACTICE INSPECTIONS“.
These guidelines provide a comprehensive framework for all stakeholders involved in clinical research related to therapeutic goods in Pakistan.
Key Features of the Updated Guidelines:
- Enhanced Clarity: This second edition streamlines the guidance, making it easier for sponsors, investigators, research institutions, and laboratories to understand the procedures for GCP inspections.
- Broader Applicability: The guidelines now explicitly cover Contract Research Organizations (CROs), BA/BE Study Centers, and Bio-Analytical Laboratories involved in clinical trials.
- Improved Transparency: The revised document clearly outlines the roles and responsibilities of both clinical research participants and DRAP inspectors during the inspection process.
- Risk based GCP Inspections
Benefits of Following these Guidelines:
- Ensuring Patient Safety: Adherence to GCP principles is critical for safeguarding the well-being of participants in clinical trials.
- Promoting Research Quality: Clear communication of inspection procedures fosters a transparent and high-quality research environment.
- Facilitating Regulatory Compliance: Understanding inspection protocols allows research entities to prepare effectively and demonstrate compliance with DRAP regulations.
We encourage all parties involved in conducting clinical research in Pakistan to download and familiarize themselves with these updated guidelines.
Download the “GUIDELINES FOR CONDUCT AND REPORTING OF GOOD CLINICAL PRACTICE INSPECTIONS”
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.