DRAP seeks comments of stakeholders on draft guidance document for Clinical Trials Applicants

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.psdra.gov.pk, copying at zeeshan.nazirdra.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Please click here to view draft guidance document Guidelines for Clinical Trials Applications