Food and Drugs Authority Ghana (FDA Ghana)
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Questions and Answers

What is the vision of the Food and Drugs Authority?

  • To ensure food security in Ghana
  • To create and sustain a Regulatory Centre of Excellence on the African Continent (correct)
  • To provide quality healthcare to the general public
  • To reduce the cost of medicine in Ghana

    • What is the main mission of the Food and Drugs Authority?

  • To reduce the cost of healthcare in Ghana
  • To promote the use of herbal medicine in Ghana
  • To protect public health by assuring the safety, efficacy and security of regulated products (correct)
  • To regulate the production and sale of tobacco

    • What is the core of the Food and Drugs Authority's quality policy?

  • To reduce the production cost of regulated products
  • To reduce the price of medicine in Ghana
  • To increase the variety of regulated products in Ghana
  • To ensure quality, safe and efficacious products through various activities (correct)

    • What is the mandate of the Food and Drugs Authority?

    <p>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</p> Signup and view all the answers

    When was the Food and Drugs Authority established?

    <p>In 1992 as the Food and Drug Board</p> Signup and view all the answers

    What is the legal basis of the Food and Drugs Authority's mandate?

    <p>The Public Health Act, 2012</p> Signup and view all the answers

    What is the composition of the governing board of the Food and Drugs Authority?

    <p>An eleven-member governing board</p> Signup and view all the answers

    What is the responsibility of the governing board of the Food and Drugs Authority?

    <p>To ensure the effective implementation of the functions of the Authority</p> Signup and view all the answers

    What is a function of the Food and Drugs Authority?

    <p>To ensure adequate standards for food, drugs, and cosmetics</p> Signup and view all the answers

    What is the role of the TAC in clinical trials?

    <p>To provide expertise to assist the FDA in making risk management decisions</p> Signup and view all the answers

    Who advises the Minister on measures for consumer health protection?

    <p>The Food and Drugs Authority</p> Signup and view all the answers

    What is the main function of the Pharmacy Council of Ghana?

    <p>To secure highest standards in the practice of Pharmacy</p> Signup and view all the answers

    What Act established the Pharmacy Council of Ghana?

    <p>The Pharmacy Act, 1994 (Act 489)</p> Signup and view all the answers

    Who is responsible for approving the initiation and conduct of clinical trials in Ghana?

    <p>The Food and Drugs Authority</p> Signup and view all the answers

    What is the primary objective of the Food and Drugs Authority?

    <p>To protect public health by ensuring the safety of food and drugs</p> Signup and view all the answers

    What is the FDA's approach to ensuring quality products?

    <p>Through registration, inspections, licensing, and surveillance</p> Signup and view all the answers

    What is the name of the law that established the Food and Drugs Authority?

    <p>Food and Drug Law of 1992</p> Signup and view all the answers

    How many technical advisory committees does the FDA have?

    <p>4</p> Signup and view all the answers

    What is the purpose of the Technical Advisory Committee on safety?

    <p>To advise on the safety of medicines</p> Signup and view all the answers

    What is the composition of the Technical Advisory Committee?

    <p>Experts from different scientific backgrounds</p> Signup and view all the answers

    What is the FDA responsible for regulating?

    <p>Food, drugs, cosmetics, medical devices, and household chemical substances</p> Signup and view all the answers

    What is the FDA's approach to customer satisfaction?

    <p>Through meeting customer needs and expectations</p> Signup and view all the answers

    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

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    Description

    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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