22 Questions
What is the vision of the Food and Drugs Authority?
To create and sustain a Regulatory Centre of Excellence on the African Continent
What is the main mission of the Food and Drugs Authority?
To protect public health by assuring the safety, efficacy and security of regulated products
What is the core of the Food and Drugs Authority's quality policy?
To ensure quality, safe and efficacious products through various activities
What is the mandate of the Food and Drugs Authority?
To regulate 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
When was the Food and Drugs Authority established?
In 1992 as the Food and Drug Board
What is the legal basis of the Food and Drugs Authority's mandate?
The Public Health Act, 2012
What is the composition of the governing board of the Food and Drugs Authority?
An eleven-member governing board
What is the responsibility of the governing board of the Food and Drugs Authority?
To ensure the effective implementation of the functions of the Authority
What is a function of the Food and Drugs Authority?
To ensure adequate standards for food, drugs, and cosmetics
What is the role of the TAC in clinical trials?
To provide expertise to assist the FDA in making risk management decisions
Who advises the Minister on measures for consumer health protection?
The Food and Drugs Authority
What is the main function of the Pharmacy Council of Ghana?
To secure highest standards in the practice of Pharmacy
What Act established the Pharmacy Council of Ghana?
The Pharmacy Act, 1994 (Act 489)
Who is responsible for approving the initiation and conduct of clinical trials in Ghana?
The Food and Drugs Authority
What is the primary objective of the Food and Drugs Authority?
To protect public health by ensuring the safety of food and drugs
What is the FDA's approach to ensuring quality products?
Through registration, inspections, licensing, and surveillance
What is the name of the law that established the Food and Drugs Authority?
Food and Drug Law of 1992
How many technical advisory committees does the FDA have?
4
What is the purpose of the Technical Advisory Committee on safety?
To advise on the safety of medicines
What is the composition of the Technical Advisory Committee?
Experts from different scientific backgrounds
What is the FDA responsible for regulating?
Food, drugs, cosmetics, medical devices, and household chemical substances
What is the FDA's approach to customer satisfaction?
Through meeting customer needs and expectations
Study Notes
Food and Drugs Authority Ghana (FDA Ghana)
- Vision: To create and sustain a Regulatory Centre of Excellence on the African Continent.
Mission
- 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
- Conduct of clinical trials in the country
Quality Policy
- Ensure quality, safe, and efficacious/ effective/ wholesome products through:
- Registration
- Inspections
- Licensing
- Surveillance
- Clinical Trials activities
- Conformity with national and international standards to meet customer satisfaction
Mandate
- 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
- Conduct of clinical trials protocols
History
- Established in 1992 as the Food and Drugs Board (FDB) based on the 1992 Food and Drug Law (PNDCL 305B)
- Renamed to Food and Drugs Authority in 2012 after the Food and Drugs Act of 1996 and Public Health Act 581, 2012
Governance
- Legal mandate 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
- Eleven-member Governing Board responsible for ensuring effective implementation of the Authority's functions
- Administered by the Chief Executive Officer, who reports to the Governing Board and oversees daily operational management, service delivery, and strategic issues.
Food and Drugs Authority, Ghana
- Vision: Create and sustain a Regulatory Centre of Excellence on the African Continent
- Mission: Protect public health by assuring the safety, efficacy, and security of various products
- Quality Policy: Ensure quality, safe, and efficacious products through registration, inspections, licensing, surveillance, and clinical trials, meeting customer satisfaction and national/international standards
- Mandate: Regulate food, drugs, food supplements, herbal/homeopathic medicines, veterinary medicines, cosmetics, medical devices, household chemical substances, tobacco, and clinical trials
- History: Established in 1992 as the Food and Drugs Board (FDB), later amended and renamed Food and Drugs Authority in 2012
Technical Advisory Committees (TAC)
- Four committees: safety of medicines, safety of vaccines and biological products, medical devices, and clinical trials
- Comprised of experts from different scientific backgrounds
- Functions: Advise the FDA on matters related to post-approval safety, efficacy, and effectiveness of products, and conduct of clinical trials
Functions of the Authority
- Ensure adequate and effective standards for products
- Monitor compliance with Public Health Act, 2012 (ACT 851) through District Assemblies and other state agencies
- Advise the Minister on measures for protecting consumer health and preparing effective regulations
- Approve initiation and conduct of clinical trials
- Perform other functions ancillary to attaining the Authority's objects
The Pharmacy Council of Ghana
- Established by the Pharmacy Act, 1994 (Act 489)
- Major function: Secure high standards in pharmacy practice in the public interest
Learn about the vision, mission, and quality policy of the Food and Drugs Authority Ghana, which regulates food, drugs, and other products to ensure public health and safety.
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