The NMRA responsible for all the pharmaceutical companies in Guinea-Bissau is the Directorate of Pharmaceutical, Laboratory and Drug Services (DIFALRM). The regulatory functions performed by the DIFALRM are marketing authorization/registration, inspection, licensing, market and quality control, pharmacovigilance, control of clinical trials, import control and promotion and advertising of medicines.
The DIFALRM is also responsible for pharmaceutical policy. The NMRA does not have a website of its own. The NMRA has benefited from external technical assistance since 2009 for the implementation of the Pharmacovigilance and Drug Registration System, with the collaboration and funding from WHO. The NMRA has been participating in harmonization and collaboration initiatives since 2005 at UEMOA and ECOWAS.

It is required by law that every pharmaceutical product be registered. There are explicit, publicly available criteria for assessment of marketing authorization requests for pharmaceuticals. The legal provisions impose the payment of a fee for the issue of market authorizations for medicines (registration) based on requests. There are legal provisions that insist that the NMRA should publish and regularly update the list of registered pharmaceutical products. Medicines are listed by their INN or by the Brand name and the INN.

There are legal provisions allowing inspectors to inspect premises where pharmaceutical activities take place. Inspections are required by law and are a prerequisite for the licensing of public and private establishments. Inspections are carried on the following entities: local manufacturers, private wholesalers, retail distributors, pharmacies, public warehouses, and pharmacies and dispensing points in health facilities.

There are no legal provisions in Guinea-Bissau that require both local and foreign manufacturers comply with Good Manufacturing Practices. Wholesalers and retailers are also not mandated by law to comply with Good Distribution Practices. There are legal provisions, however, that require importers to be authorized.
Manufacturers are required to obtain a manufacturing license and to comply with Good Manufacturing Practices (GMP). Guidelines on Good Manufacturing Practices have been published by the government. Legal provisions requiring importers, wholesalers, and distributors to be licensed and requiring wholesalers and distributors to comply with Good Distribution Practices also exist.
Guidelines for Good Distribution Practices have been published by the government as well. There exist legal provisions requiring pharmacists to be registered. While private pharmacies are required to be licensed, these obligations do not extend to public pharmacies. There are government-published guidelines on Good Pharmacy Practice.

There is legislation imposing an import authorization on medication imported into the country. There are also legal provisions that authorize the sampling of imported medication for testing. The imported medicines are also to be inspected at the ports of entry.

There are legal provisions that require Marketing Authorization Holders to continuously monitor and report the safety of their drugs to the NMRA. There is a National Pharmacovigilance Center that collaborates with the NMRA. There is a standard ADR reporting form. All adverse events reports are kept in a national Adverse Event Database. These reports are also sent to the WHO collaborating center in Uppsala.

There are no legal provisions for market control of pharmaceuticals. There is no laboratory in Guinea-Bissau that analyses drugs for quality control.

To conduct clinical trials in Guinea Bissau, it is required by law to have authorization from the DIFALM. There are laws governing the approval of an ethics committee or a board institutional review of clinical trials to be performed.

According to the WHO Pharmaceutical Country Profile, the NMRA uses a computerized information management system to store and retrieve information on the various regulatory procedures, however further information is not provided on this information system is not provided. The NMRA does not have a website (World Health Organization, 2011).

In Kenya, the authority in-charge of medicine regulation and administration is the Pharmacy and Poisons Board (PPB). The PPB operates as a department of the Ministry of Health, but there are initiatives to establish it as a semi-autonomous agency under the MoH. The MRA has its own website. The MRA is involved in harmonization/collaboration initiatives, which include the African Medicines Regulatory Harmonization and the Harmonization of Medicines Registration in the EAC.

Legal provisions require that all pharmaceutical products on the market receive marketing authorization (registration). Explicit and publicly available criteria exist for assessing applications for marketing authorization of pharmaceutical products. However, there are no legal provisions requiring the MRA to make the list of registered pharmaceutical products publicly available regularly. Medicines are registered by their INN (International Non-proprietary Names) or Brand name + INN. The MRA charges a fee for Medicines Market Authorization (registration) based on applications made.

Kenya has 43 regulatory inspectors across the country. The inspectors are permitted to inspect premises where pharmaceutical activities are performed – these provisions require inspections to be performed. Inspection is a prerequisite for licensing facilities and the requirements are the same for both public and private facilities.

Laws exist that allow the sampling of imported products for testing. Legal provisions requiring the importation of medicines through authorized ports of entry also exist. Regulations or laws exist to allow for inspection of imported pharmaceutical products at the authorized port of entry.

In Kenya, there are legal provisions for controlling the pharmaceutical market and there is a national laboratory for Quality Control testing. Samples are collected by government inspectors and sent to the laboratory for post-marketing surveillance testing.

The government is responsible for regulating promotion and/or advertising of medicines. There are legal provisions requiring the pre-approval of medicines advertisements and promotional materials; direct advertising of prescription medicines to the public is prohibited. There is a national code of conduct to guide advertising and promotion of medicines undertaken by Marketing Authorization holders. Adherence to the code is compulsory and the code contains a formal process for complaints and sanctions.

Laws require that agreement by an ethics committee or institutional review board of the Clinical Trials for clinical trials to be performed. Registration of the clinical trials in an international/national/regional registry is required by law. A National CT Registry is currently under development by the Pharmacy and Poisons Board.

Pharmacovigilance activities are considered as part of the MRA mandate. Legal provisions exist regarding the monitoring of Adverse Drug Reactions (ADR) in Kenya and requiring Marketing Authorization holders to continuously monitor the safety of their products and report to the MRA. A national Pharmacovigilance centre linked to the MRA exists.