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Guidance on Clinical Trial Applications -

The Drug Regulatory Authority of Pakistan (DRAP) published the draft of this guidance document on its website on 8th April 2022 inviting the comments of stakeholders on the draft. After thorough consultation and careful consideration, the first edition of the guidance document on the clinical trial applications is finalized.

This document provides general guidance to the applicants in making new applications for clinical trials on therapeutic goods, or any subsequent submissions and regulatory requirements to be fulfilled. It also provides an outline of the procedure for submission, review, evaluation, and approval of applications for the conduct of clinical trials.

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

These guidelines explain the procedures for filing applications for clinical trials and provide an insight into the steps to be followed by the applicants.


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