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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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  • Drug Safety & Monitoring
  • Food Safety & Monitoring
  • fda ghana,working for your safety
The Food and Drugs Authority (FDA) formerly the Food and Drugs Board (FDB) was established in August 1997 under the Food and Drugs Law, 1992 (PNDCL 305B). It is the National Regulatory Authority mandated by the public Health Act, 2012 (Act 851) to regulate food, drugs, food supplements, herbal and homeopathic medicines, veterinary medicines, cosmetics, medical devices, household chemical substances, tobacco and tobacco products.

The FDA Ghana's legal mandate is found in part 6 (Tobacco Control Measures), part 7 (Food and Drugs), and part 8 (Clinical trials) of the Public Health Act, Act 851 of 2012. The FDA is an Agency under the Ministry of Health with an eleven member Governing Board inclusive of the Chief Executive Officer who is responsible for the day to day administration of the FDA.

The objective of the Authority is to provide and enforce standards for the sale of food, herbal medicinal products, cosmetics, drugs, medical devices and household chemical substances.

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
  • United States Department of Agriculture (USDA)