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Compendium of Guidelines on Medicines Evaluation and Registration In Kenya

This Compendium, developed by the Pharmacy and Poisons Board (PPB), provides a comprehensive reference for the evaluation and registration of medicines in Kenya. It consolidates applicable national and regional regulatory requirements to support the consistent evaluation and registration of medicinal products and to ensure that they meet the required standards of quality, safety and efficacy.

Scope

The Compendium comprises nine parts, which collectively provide requirements and guidance for the submission, evaluation, registration and regulatory management of human medicinal products.

Parts I–III primarily provide technical requirements and supporting procedures applicable to chemical pharmaceutical products containing synthetic or semi-synthetic APIs. Part VII establishes procedural requirements applicable to all types of applications submitted to PPB, including applications for biological products. Part VIII provides requirements for the naming of medicinal products and includes considerations applicable to products such as vaccines and biological medicinal products.

Applicants should identify and apply the relevant Part(s) according to the type of medicinal product, the nature of the application and the applicable regulatory pathway.

Main Content

Part I of the Compendium outlines the requirements for structuring applications for medicinal products containing active pharmaceutical ingredients (APIs) of synthetic or semi-synthetic origin in accordance with the Common Technical Document (CTD) format, which comprises the following modules:

• Module 1: Administrative and prescribing information
• Module 2: Quality overall summaries
• Module 3: Quality information (chemical, pharmaceutical and biological data)
• Module 4: Non-clinical study reports
• Module 5: Clinical study reports

The specific data requirements for each module may vary and are determined on a case-by-case basis. These requirements depend on several factors, including the type of medicinal product, the nature and source of the active pharmaceutical ingredient (API), the intended indication, the route of administration, and the regulatory pathway being followed (e.g., full dossier, abridged or generic application).

Attached Files

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016_HPT_PER_GUD_COMPENDIUM OF GUIDELINES ON MEDICINES EVALUATION AND REGISTRATION IN KENYA .pdf

4.4 mb2026-07-02

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