Legal Mandate

The FDA was formally mandated by the Food and Drugs Law of 1992, PNDCL 305B and its amendment, Act 523. In 2012, this law was reviewed and the Public Health Act (PHA) 2012, Act 851 was passed to increase the scope and enhance public health and safety. Part 8, Sections 150-166 of the PHA 2012, Act 851 mandates the FDA to regulate Clinical Trials.

The legal mandate of the FDA as per the PHA is to authorize and monitor clinical trials through;

Development of appropriate guidelines for the conduct of clinical trials
Issuance of CT Certificates (permit for conducting clinical trials)
Reviewing of all reports from trial sites
Conducting Good Clinical Practice(GCP) inspection at trials sites to ensure compliance of trials to international best practices and local regulatory requirements
Investigating the conduct of clinical trial
Suspension or stopping clinical trials(if necessary)

The Technical Advisory Committee on Clinical Trials

To satisfy requirements of the law, 12-member experts committee(an advisory Committee on Clinical Trials), whose objective is to provide the FDA with ongoing and timely medical and scientific advice on current and emerging issues related to clinical trials, has been established. Current members of the Committee with their respective expertise are as follows: