Food and Drugs Authority Ghana

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.

Micellisation

• The number of surfactant monomers increases at the interface until a concentration is reached where they self-assemble in the bulk of the surfactant solution to form aggregates called micelles.
• Micelles are formed as an alternative to overcrowding of the interface.
• The concentration at which micelles begin to form is the critical micelle concentration (CMC).

Types of Micelles

• Non-ionic micelle
• Anionic micelle
• Cationic micelle

Structure of Micelles

• Micelles have a hydrocarbon core and a Stern layer with ionic head groups.
• Guoy-Chapman layer is present at the surface of the micelle.

Solubilisation

• Micelles are dynamic species with liquid-like interiors.
• Certain orientations and locations within the micelle may be greatly preferred depending on the nature of the solubilisate.
• Solubilisates can be located in different parts of the micelle, including:
  • The surface of the micelle
  • Between the hydrophilic head groups
  • Palisade layer
  • Deeper in the palisade layer
  • Micelle core

Factors Affecting Solubilisation

• Surfactant:
  • Size of micelle affects solubilisation, with larger micelles generally solubilising more material.
  • CMC affects solubilisation, with non-ionic surfactants being better solubilising agents than ionics in very dilute solutions.
• Solubilisate:
  • Crystalline solids have less solubility in micelles than liquids of similar structure.
• Electrolyte:
  • Addition of electrolyte to ionic micelles decreases CMC and increases aggregation number, leading to increased solubilisation.
• Temperature:
  • Increased temperature for ionic surfactants increases the extent of solubilisation for both polar and nonpolar solubilisates.
  • Increased thermal agitation generally increases the space available for solubilisation in the micelle.