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Schedule of Meetings of Clinical Studies Committee (CSC) for the Year 2024

Asad Ullah Clinical Trials

The Clinical Studies Committee (CSC) of Drug Regulatory Authority of Pakistan (DRAP) is mandated under Bio Study Rules 2017 for the regulatory oversight of clinical trials and clinical studies related to therapeutic goods in the country. The CSC reviews and approves clinical study protocols, ensuring they adhere to ethical and scientific standards. It also monitors ongoing clinical trials to assess participant safety and efficacy, makes informed decisions regarding study design, and collaborates with researchers, sponsors, and other stakeholders to ensure quality clinical research and safety of the participants.

The Committee has decided that the CSC meetings will be convened after every 45 days and an annual CSC meeting schedule for 2024 (tentative) has been issued with the aims to enhance transparency, efficiency, and collaboration.

S. No.CSC MeetingProposed Dates
0149th CSC Meeting2nd week of May, 2024
0250th CSC Meeting4th week of June, 2024
0351st CSC Meeting2nd week of August, 2024
0452nd CSC Meeting4th week of September, 2024
0553rd CSC Meeting2nd week of November 2024
0654th CSC Meeting4th week of December, 2024
Anaual-Tentative-CSC-PlanDownload

Comments are invited on revision of Guidelines on Inspection of Good Clinical Practices for Clinical Trials

Asad Ullah Clinical Trials, Drugs

The Drug Regulatory Authority of Pakistan (DRAP) is planning to revise its guideline for the conduct of Good Clinical Practice (GCP) inspection and reporting. The current guideline was issued in 2022 and provides the procedure and criteria for GCP inspections of clinical trials regulated by DRAP.

The revision aims to update the guideline in accordance with the latest international standards and best practices, as well as to address the feedback and suggestions received from the stakeholders. The revised guideline will cover the following aspects:

  • The objectives and scope of GCP inspections
  • The preparation and planning of GCP inspections
  • The conduct and documentation of GCP inspections
  • The follow-up and closure of GCP inspections

DRAP invites all interested parties, including sponsors, investigators, ethics committees, contract research organizations, and other relevant entities, to provide their comments and inputs on the revision of the guideline. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using prescribed format, (further information on comments submission can access on this link. Comments and suggestions can be forwarded via email to shafqat.hussain∂dra.gov.pk with copy to dir.ps∂dra.gov.pk or can be posted at following mailing address: Assistant Director (Clinical Research), Pharmacy Services Division, Drug Regulatory Authority of Pakistan, DRAP-NCLB Building, Prime Minister’s Health Complex, Park Road, Chak Shahzad, Islamabad, Pakistan.

DRAP appreciates your participation and contribution to this consultation process. Your comments and inputs will help us to improve the quality and effectiveness of our GCP inspection and reporting system.

Draft GCP_Inspection Guidelines-Final (1)Download

Stakeholders Comments are invited on revision of Guidelines on Conduct of Clinical Trials in Pakistan

Asad Ullah Clinical Trials, Drugs

The Drug Regulatory Authority of Pakistan (DRAP) is revising Guidelines on Conduct of Clinical Trials in Pakistan with the aim to ensure the safety, quality, and efficacy of investigational products in clinical trials, as well as the ethical conduct and oversight of clinical research in Pakistan.

The revised guidelines cover various aspects of clinical trial activities, such as:

  • The regulatory framework and approval process for clinical trials in Pakistan
  • The roles and responsibilities of various stakeholders involved in clinical trial activities, such as DRAP, National Bio Ethics Committee, sponsors, investigators, and pharmaceutical associations
  • The requirements and procedures for obtaining informed consent, protecting the rights and welfare of trial participants, and reporting adverse events and serious adverse events
  • The standards and principles for designing, conducting, monitoring, recording, analyzing, and reporting clinical trials
  • The good clinical practice (GCP) requirements for clinical trial materials and investigational products
  • The data management and quality assurance systems for clinical trial data and documents
  • The post-trial obligations and follow-up measures for clinical trial sponsors and investigators

The revised guidelines are based on the best regulatory practices as per the International Council for Harmonisation (ICH) guidelines, and the World Health Organization (WHO) guidelines.

The revised guidelines are open for public comments until February 22, 2024. DRAP invites all the relevant stakeholders, such as pharmaceutical companies, research institutions, clinical trial organizations, health professionals, patient groups, 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 shafqat.hussain∂dra.gov.pk or can be posted at mailing address, Director, Division of Pharmacy Services, 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.

Draft-Guidelines-for-Conduct-of-Clinical-Research-in-Pakistan_06_02_24_AmendedDownload

SRO 685(I)/2023 dated 09-06-2023: Amendments in the Bio Study Rules, 2017

Asad Ullah Clinical Trials, SROs

The Drug Regulatory Authority of Pakistan, with the Federal Government’s approval, has made amendments to the Bio-Study Rule 2017. Through this amendments, the Application Form (Form-IIA) for BA/BE Studies has been revised to rationalize the requirement for submission of the reference product’s Certificate of Pharmaceutical Products (CoPP). The Notification issued in this regard is as under:-

S.R.O.-685-Form-IIADownload

DRAP issued Consolidated Notification for Regulatory Fees

Asad Ullah Advertisements, Alternative Medicines, Clinical Trials, Controlled Substances, Drugs, General, Licensing and Inspections, Medical Devices, Notifications, SROs

Drug Regulatory Authority of Pakistan (DRAP) issued a consolidated notification of Regulatory fess for various functions and services. This notification is issued under the section (1) of section 20 of the Drug Regulatory Authority of Pakistan Act, 2012 (XX.I of 2012) read with sub-rule (3) of rule 4 of the Drug Regulatory Authority of Pakistan (Fee and Levy) Rules, 2022, and in supersession of all such previous Notifications. The Drug Regulatory Authority of Pakistan with the approval of the Policy Board has specified these regulatory fees. The Notification is provided as under: –

DRAP-Consolidated-Fee-17.04.2023Download

DRAP issues guidance on the submissions of Clinical Trials Applications

Asad Ullah Clinical Trials, Publications, Regulatory Updates, Uncategorized

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 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 on the procedure for submission, review, evaluation and approval of applications for the conduct of clinical trials.

These guidelines will assist 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 explains the procedures for filing applications of clinical trials and provides an insight on the steps to be followed by the applicants. As per DRAP Act, 2012 and Drug Act, 1976 it is required that all the therapeutic goods marketed in Pakistan must have a valid authorization / registration with the Drug Regulatory Authority of Pakistan (DRAP), and any clinical trials 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.

DRAP published the draft of this guidance document on its website on 8th April, 2022 inviting the comments of stakeholders on the draft. After through consultation and careful consideration, fist edition of the guidance document on the clinical trial applications is finalized. Nevertheless, anyone can still furnish his/her comments on the guidance documents using our comments submissions methods for consideration in the future editions of the document.

Please click here to view the Guidance on Clinical Trials Applications