Clinical Trial Regulation

The Clinical Trials Regulation Directorate is responsible for the review, authorization, and oversight of clinical research involving medicines, vaccines, medical devices, and other regulated products. The Directorate ensures that clinical trials conducted in Zambia adhere to national legislation, ethical principles, and internationally accepted standards of good clinical practice.

The Directorate evaluates study protocols, investigator qualifications, participant protection measures, and safety monitoring plans before approving clinical trials. Ongoing monitoring and inspections are conducted to ensure compliance throughout the duration of the study. Through effective regulation of clinical research, ZAMRA supports scientific innovation while safeguarding the rights, safety, and well-being of research participants.