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DRAP seeks comments of stakeholders on draft guidance document for Clinical Trials Applicants

Asad Ullah Clinical Trials

The Drug Regulatory Authority of Pakistan (DRAP) regulates the conduct of clinical trials of therapeutic goods in Pakistan under the Bio-Study Rules, 2017. This document is intended to provide general guidance to applicants in making new applications for clinical trials on therapeutic goods, or any subsequent submissions to the Drug Regulatory Authority of Pakistan (DRAP). The current guideline describes the regulatory requirements, procedure for submission, review, evaluation and approval of applications for the conduct of clinical trial.

These guidelines are applicable on the sponsors, researchers, investigators, clinical research organization (CRO), who intends to submit a new application for conduct of a clinical trials or its subsequent submissions under the regulatory scope of the Bio-Study Rules, 2017.

These guidelines will assist researchers / investigators on the procedures for filing applications of clinical trials and will provide an insight on the steps to be followed by the applicants who wish to conduct clinical trials in Pakistan. It is required that all the therapeutic goods and health products used in Pakistan are registered with the Drug Regulatory Authority of Pakistan (DRAP) and any clinical trial using such registered or unregistered products must receive written approval (i.e. license for Clinical Trial Site & Clinical Studies) from DRAP, under the Bio-Study Rules 2017 for that purpose.

Stakeholders can submit their comments and suggestions with 15 days of uploading of this document using prescribed format to submit comments (link to access table of comments), and forward via email to dir.ps∂dra.gov.pk, copying at zeeshan.nazir∂dra.gov.pk, or can post at mailing address Director, Pharmacy Services, 3rd floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.

Please click here to view draft guidance document Guidelines for Clinical Trials Applications

DRAP holds meeting of provincials’ health departments and drug control organizations of all federating units to strengthen the regulatory oversight through an integrated and harmonized regulatory approach.

Asad Ullah Events
DRAP holds meeting of provincials’ health departments and drug control organizations of all federating units to strengthen the regulatory oversight through an integrated and harmonized regulatory approach.

Drug Regulatory Authority of Pakistan (DRAP) is continuously engaged in strengthening national regulatory framework in collaboration with all stakeholders. In this context, a meeting of regulators was convened on 1st April, 2022 at Islamabad to review the all cross cutting regulatory functions. Senior managements from Drug Control Organizations, Quality Control Boards and Drug Testing Laboratories participated in the meeting.

Deficiency Letters from EEC meetings from 95 to 103

Yasir Mahmood Alternative Medicines, Enlistment Evaluation Committee
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DRAP launched Online Import Export System (OIES) to regulate import and export of therapeutics goods across the country.

Asad Ullah Events, News & Updates, Uncategorized
DRAP launched Online Import Export System (OIES) to regulate import and export of therapeutics goods across the country.

In line with the vision of Prime Minister of Pakistan, and to facilitate the therapeutic goods’ industry for ease of business and provision of conducive environment for compliance to regulatory requirement, Drug Regulatory Authority of Pakistan (DRAP) has introduced an electronic application management system which will enable applicants and regulators to communicate electronically for management of import and export information of therapeutic goods. Online Import / Export Application System (OIES) is accessible through the official website of DRAP under E-Services. A guidance document on operational features of the online Import / Export Application System is also available to assist applicants for submission of information. This system will also enable applicants to view / maintain all submissions related to import & export to DRAP through an individualized dashboard for each user.