Overview
The FDA was established in 1992 as the Food and Drugs Board (FDB) on the basis of the 1992 Food and Drug Law (PNDCL 305B), later amended by the Food and Drugs ACT of 1996. The Food and Drugs legislation was revised in 2012 and integrated into a new Public Health ACT 851, 2012 that gave birth to the Food and Drugs Authority.
The FDA’s legal mandate is found in Part 6 (Tobacco Control Measures), Part 7 (organisation and responsibilities of the FDA), and Part 8 (Clinical trials) of the Public Health Act, 2012 Act 851.
Who We Are
The FDA is the National Regulatory Body responsible for the regulation of food, drugs, food supplements, herbal and homeopathic medicines, veterinary medicines, cosmetics, medical devices, household chemical substances, tobacco and tobacco products, blood and blood products as well as the conduct of clinical trials protocols. The Public Health Act, 2012, Act 851 provides for the establishment of a Governing Board with the responsibility of ensuring the effective implementation of the functions of the Authority. The Authority currently has eleven-member Governing Board.
Administratively, the FDA is headed by the Chief Executive Officer who reports directly to the Governing Board. The Chief Executive Officer of the FDA takes responsibility for the daily operational management, service delivery and strategic issues of the FDA.
The FDA has five (5) technical advisory committees (TAC) for safety of medicines, safety of vaccines and biological products, medical devices, clinical trials and nutrition. The committees are made up of experts from different scientific backgrounds. The TAC provides expertise to assist the FDA in making appropriate risk management decisions, however, the decision-making responsibility remains with the FDA.
Functions of the Authority
- - Ensure adequate and effective standards for FDA regulated products.
- - Monitor through the District Assemblies and any other agency of state compliance with the provisions of Part 6, 7 and 8 of the Public Health Act, 2012 (Act 851).
- - Advise the Minister of Health on measures for the protection of the health of consumers.
- - Advise the Minister of Health on the preparation of effective Regulations for the implementation of Part 6, 7 and 8 of the Public Health Act, 2012 (Act 851).
- - Approve the initiation and conduct of clinical trials in the country.
- - Perform any other functions that are ancillary to attaining the objective of the Authority.
