Working for your safety

FOOD AND DRUGS AUTHORITY GHANA

Regional Center of Regulatory Excellence in Clinical Trials, Drug Registration and Pharmacovigilance
FDA's Laboratory is ISO/IEC 17025:2005 accredited in the field of Testing. Accredited by ANSI-ASQ National Accreditation Board/ANAB of USA and a member of ILAC

Attention: Submission of Dossier In Two Electronic Copies form Sept 1,2015

The Food and Drugs Authority (FDA) wishes to bring to the attention of all manufacturers and importers of allopathic medical products that from September 1,2015, all dossiers and supporting documentation for both registration and re-registration and variations of finished pharmaceutical products should be  submitted in Two Electronic Copies Only.

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Food and Drugs Authority's Vision


To create and sustain a Regulatory Centre of Excellence on the African Continent.

Food and Drugs Authority's Mission

The FDA exists to protect public health by assuring the safety, efficacy and security of human and veterinary drugs, food, biological products, cosmetics, medical devices,  household chemical substances, tobacco and the conduct of clinical trials in the country.

 

The Food Drugs Authority (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 and the conduct of clinical trials protocols.

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 581, 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.

The Public Health Act,2012 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 four (4) technical advisory committees (TAC) for safety of medicines, safety of vaccines and biological products, medical devices and clinical trials. The committees are made up of experts from different scientific backgrounds. The TAC on safety was formed to act as a forum to advise the FDA on matters relating to post-approval safety, efficacy, and effectiveness of the products granted marketing authorization by the Authority. The TAC for clinical trials also advises the FDA on matters related to the conduct of clinical trials. 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

  • a) Ensure adequate and effective standards for food,drugs, cosmetics, household chemicals and medical devices;
  • b) 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);
  • c)Advise the Minister on measures for the protection of the health of consumers;
  • d)Advise the Minister on the preparation of effective Regulations for the implementation of Part 6,7 and 8 of the Public Health Act,2012 (ACT 851);
  • e)Approve the initiation and conduct of clinical trials in the country;
  • f) Perform any other functions that are ancillary to attaining the objects of the Authority.
  • Bureau of National Investigations
  • Ghana Police Service
  • Customs Excise and Preventive Service
  • Pharmacy Council
  • Ghana Standards Authority
  • Veterinary Services Directorate
  • Environmental Protection Agency
  • Narcotics Control Board
  • Noguchi Memorial Institute for Medical Research
  • Centre for Scientific Research into Plant Medicine
  • Plant Research and Regulatory Services Department
  • Food Research Institute
  • Kwame Nkrumah University of Science and Technology, Food Science Department
  • University of Ghana, Food Science Department
  • Ministry of Local Government and Rural Development, Environmental Health Department
  • Global Alliance for Improved Nutrition (GAIN)
  • World Health Organization
  • Food and Agriculture Organization
  • United States Pharmacopoeia Commission
  • International Narcotics Control Board (INCB)
  • Campden BRI
  • International Food Safety Authority Network
  • United States Food and Drugs Administration
  • Codex Alimentarius Commission
  • UNICEF
  • GO-GLOBAL
  • United States Department of Agriculture (USDA)