Medicine Regulation is governed by the Medicine Control Agency, which is a part of Gambia’s Ministry of Health. The functions of the MCA are market authorization, inspection, pharmacovigilance, import control, licensing, quality control, medicine advertisement and promotion, and clinical trials control.

The authority regulates the use of drugs, herbal medicines, medical devices, cosmetics and domestic household chemicals. Application forms and registration guidelines for each of these products can be found on the MCA website. For any registration, the application form must be completed by the applicant for each dosage form and/or strength of the medicine. The application form shall be dated, signed and stamped by the applicant and indicate the Local Representative, if applicable the application form. All product registration application dossiers are to be submitted in CTD format and in both hard and softcopy.

The agency inspects ports of entry, wholesalers, warehouses, Central Medical Store, regional medical stores, pharmaceutical stores at both private and public hospitals and health centers, pharmacies, drugstore outlets, and private or NGO clinic pharmacies as well as any other premise that stores, distribute, dispense or sells medicines or related products. There are 5 types of inspections conducted namely:
·       Comprehensive/Routine. These inspections are conducted for new premises, existing premises seeking a license renewal and for establishments that change key personnel or processes, that have not been inspected in a long time or have a history of non-compliance
·       Concise. Concise inspections are generally for establishments that have previously been routinely inspected with a view to assessing a limited number of standards of applicable regulatory requirements and good practices selected as indicators of overall performance and identification of significant changes which has been introduced since last inspection.
·       Follow-up. A follow-up inspection is normally made to monitor corrective measures that have been undertaken following advice and notice given during a previous inspection.
·       Special. This type of inspection is conducted on establishments whose operations were unknown, have a product defect complaint or have a report of adverse drug reactions.
·       Investigative. An investigative inspection is conducted to verify complaints received about non-compliance with standards of good and/or professional practice.

To report ADRs, the reporter has to download and complete ADR reporting forms that have been made available on the MCA website. The form asks for the patient’s details, a description of the adverse event and the outcome of the event, other medications taken within the last 3 months of the report, and the personal details of the reporter. The report can be submitted to the MCA office or via email to info@mca.gm. Guidelines for pharmacovigilance can also be found on the agency’s website. Gambia is an associate member state of the WHO International Drug Monitoring Programme.

Only importers who are licensed by the Agency are permitted to import medicines and related products. Guidelines for importation of medicines and applications for an import permit can be found on the agency’s website. Governmental and non-governmental organizations that provide health services may import drugs in reasonable quantities for use only in their facilities and only if the drug is not available in the country. People with special prescriptions may also have medicines imported into the country.

Medicines are tested for quality monitoring in the public and private sector and when there are complaints or problem reports.

The agency issues licenses to manufacturers, importers, and storage facilities. The application forms and guidelines for the licenses can be found on the agency’s website.