Gabon
Official Name: Gabonese Republic
Capital: Libreville
Independence Day: 17 August 1960
Currency: CFA franc
Indicators
Regulatory Framework
The Directorate of Medicine and Pharmacy is a regulatory body under the Gabon Ministry of Health that regulates the pharmaceutical sector. The NMRA is charged with marketing authorization and product registration, inspection, licensing, import control, clinical trials control, quality and market control, pharmacovigilance, drug promotion and advertisement, and regulating improved traditional medicines. The NMRA does not have its own website.
Marketing Authorization and Registration
A marketing authorization is required for all pharmaceutical products marketed in Gabon. There are no mechanisms of recognition that approve drugs that have been approved by other countries. Market authorization requests should be accompanied by a certificate of compliance to the WHO certification system. It takes 3 months to evaluate market authorization requests and it is mandated by law for a committee of experts to be involved in the market authorization process.
Inspection
Inspection is a pre-requisite to obtain a license to operate public and private pharmaceutical facilities. Private wholesalers, retail pharmacies, public pharmacies and warehouses, and pharmacies of health facilities are to be inspected. Inspections on these facilities are carried out at least once a year.
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.
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.
Licensing
There is legislation that requires importers, wholesalers, distributors, pharmacists and local manufacturers to be licensed. There are also legal provisions that require both domestic and international manufacturers to comply with GMP guidelines, and wholesalers and distributors to comply with Good Distribution Practices.
Import Control
The importation of pharmaceuticals is subject to authorization. However, the importation of pharmaceutical products is not limited to just the authorized ports of entry. The law requires that pharmaceuticals are inspected, and samples are taken for testing at the authorized points of entry.
Quality and Market Control
There is no lab in the country that tests medicine samples. Medicine samples are tested in Central African Economic and Monetary Community (CEMAC) countries with laboratories.
Clinical Trials
Carrying out clinical trials requires the approval of an ethics committee or an institutional evaluation board. The products to be examined must be GMP compliant. The sponsor and principal investigator are also supposed to comply with Good Clinical Practices (GCP). Establishments where clinical trials are carried out are supposed to be inspected by the NMRA.
Pharmacovigilance
An MA holder is required to continuously monitor their products on the market and report their safety to the NMRA. Monitoring of adverse events is mandatory and standardized forms are provided to health facilities to collect adverse events reports. There is no national Pharmacovigilance Centre and no national database for ADR reports, thus the NMRA does not send ADR reports to the WHO collaborating center in Uppsala.
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.
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.
Information Management System
According to the WHO Country Profile, the NMRA has a computerized information management system for registration, inspections and other regulatory processes.
Medicine regulation
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.
Market Authorization/Registration
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.
Importation
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.
Quality Control
Medicines are tested for quality monitoring in the public and private sector and when there are complaints or problem reports.
Licensing
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.