Clinical trials: DRAP seeks suggestions on revision of guidelines by 22nd

ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) has asked all the stakeholders to send their suggestions and comments on the revision of guidelines on conducting clinical trials in Pakistan by February 22, 2024.

In an invitation released here on Wednesday, the regulatory authority said that it was revising guidelines on the 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: (i) The regulatory framework and approval process for clinical trials in Pakistan; (ii) The roles and responsibilities of various stakeholders involved in clinical trial activities, such as DRAP, National Bio Ethics Committee, sponsors, investigators, and pharmaceutical associations; (iii) The requirements and procedures for obtaining informed consent, protecting the rights and welfare of trial participants, and reporting adverse events and serious adverse events; (iv) The standards and principles for designing, conducting, monitoring, recording, analyzing, and reporting clinical trials; (v) The good clinical practice (GCP) requirements for clinical trial materials and investigational products; (vi) The data management and quality assurance systems for clinical trial data and documents; and (vii) 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 Organisation (WHO) guidelines.

The revised guidelines are open for public comments until February 22, 2024. The DRAP invites all the relevant stakeholders, such as pharmaceutical companies, research institutions, clinical trial organisations, health professionals, patient groups, and civil society organisations, to review the revised guidelines and provide their feedback and suggestions.

Stakeholders can submit their comments and suggestions using the prescribed format available online via email to [email protected] or can be posted at mailing address, Director, Division of Pharmacy Services, Drug Regulatory Authority of Pakistan, PM health Complex, Park Road, Islamabad.

The DRAP appreciates the cooperation and contribution of all the stakeholders in the development and improvement of the guidelines on the conduct of clinical trials in Pakistan.

The 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.

Copyright Business Recorder, 2024