The Pharmacy and Poisons Board (PPB) operates under the Pharmacy and Poisons Act (Cap 244) and is responsible for registering pharmaceutical products, licensing manufacturing facilities and pharmacies, approving clinical trials, and controlling importation and distribution.
Product Registration
Any pharmaceutical product sold in Kenya must be registered by the PPB before placement on the market. Registration involves submission of dossiers covering quality, safety, and efficacy, including manufacturing data, clinical study data, and proposed labelling. Registration for innovative products can take 12 to 24 months. Abridged procedures apply for generics.
Manufacturing Licensing
Pharmaceutical manufacturers must hold a manufacturing licence from the PPB and comply with Good Manufacturing Practice (GMP) standards. The PPB conducts regular facility inspections. Manufacturers supplying government programmes may also need WHO prequalification.
Clinical Trials
Clinical trials require approval from the PPB and a Registered Ethics Review Committee. Requirements include a GCP-compliant protocol, informed consent documentation, and insurance coverage for trial participants.
Importation and Distribution
Importation requires a valid PPB import licence and product registration. The PPB operates a Pre-Export Verification of Conformity (PVoC) programme for certain categories. Counterfeit medicines are a significant enforcement priority.
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