The Food and Drugs Authority (FDA) regulates medicines in Ghana. The FDA performs the following regulatory functions: market authorization, pharmacovigilance, clinical trials, inspection, licensing, market and quality control, and medicines advertising and promotion.

Guidelines on registering food, drugs, medical devices, cosmetics and household chemicals can be found on the FDA website. The applications for product registration can also be found on the website. Medicines are always registered by their INN (International Non-proprietary Names) or the Brand name and the INN. The MRA is also involved in harmonization/collaboration initiatives such as West African Health Organization harmonization of registration and inspection requirements.

Inspections are required by law and a pre-requisite for licensing private facilities. The Food and Drugs Board inspects factories, warehouses and carries out post-market surveillance. Inspections are carried out annually to ensure that local manufacturers, private wholesalers, retail distributors, public pharmacies and health stores, and pharmacies of health facilities are complying with good manufacturing and distribution practices (World Health Organization, 2012).

There is an online ADR reporting form on the FDA website. Ghana is also a member state of WHO’s International Drug Monitoring Programme. The FDA has an online database, Safety Watch System (SWS) that is ICH E2B compliant for management of reports received. Spontaneous reports received are sent to the WHO International Drug Monitoring Programme as an E2B (xml) file. The SWS can be accessed via: http://adr.fdaghana.gov.gh/. There is also a programme in collaboration with the Ghana Health Service to peer review pharmacovigilance performance of health facilities using the Pharmacovigilance Assessment Tool (PAT) adapted from the Indicator-Based Pharmacovigilance Assessment Tool (IPAT) developed by Strengthening Pharmaceutical Systems (SPS) programme. This is to ensure that pharmacovigilance issues are promoted within the healthcare facilities by measuring their PV performance using a set of indicators (Food and Drugs Authority of Ghana).

Importers, wholesalers and distributors require licenses before they can start operations. Local manufacturers and importers are required to comply with Good Manufacturing Practices and wholesalers and distributers comply with Good Distribution Practices.

There is a laboratory that is a functional part of the FDA where medicines are tested. Medicines are tested for several reasons. These include quality monitoring in the public sector, quality monitoring in the private sector and for product registration and when complaints and problem reports have been made about a drug.

The application for an import permit can be found on the FDA website. Imported pharmaceutical products must be inspected at the authorized ports of entry.

The FDA authorizes and monitors clinical trials by developing appropriate guidelines for the conduct of clinical trials, issuing Clinical Trial Certificates, reviewing all reports from trial sites, conducting Good Clinical Practice (GCP) inspection at trial sites to ensure compliance of trials to international best practices and local regulatory requirements; investigating the conduct of clinical trial and suspension or stopping clinical trials (if necessary).

The Food and Drugs Authority has an information management system that is used for inspections, product registration and other regulatory procedures (World Health Organization, 2012).