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.

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.

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.