Clinical Trials

Section 74 of the PMRA Act mandates the PMRA to authorize the conduct of clinical trials in accordance with the principles of Good Clinical Practice (GCP). This is done through the review of clinical trials applications (CTAs) and issuance of clinical trial certificates.

The PMRA receives CTAs through the office of the Director General. The applicant must submit evidence of ethical clearance from either the National Health Science Research Committee (NHSRC) of the National Commission for Science and Technology (NCST) or the College of Medicine Research Ethics Committee (COMREC).

The Board of Directors approves the licensing and registration of CTA upon recommendation from the Clinical Trial Review Committee (CTRC). The approval granted may be full or conditional depending on the nature of the findings of CTRC. Post authorization GCP inspection is done for selected implemented clinical trials depending on the risk profile of the study.