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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 national and regional regulatory requirements to ensure that all medicinal products meet the required standards of quality, safety, and efficacy.

Scope

These guidelines are intended to assist applicants in preparing applications for the registration of medicinal products for human use. The required format for such applications is the Common Technical Document (CTD).

These guidelines apply specifically to marketing authorization (MA) applications for medicinal products containing active pharmaceutical ingredients (APIs) of synthetic or semi-synthetic origin. Biological products, biotechnological products, herbal medicines, medical devices, and in vitro diagnostics (IVDs) are not covered here, as they are addressed in separate guidelines.

Main content

This guideline outlines the requirements for structuring applications in accordance with the Common Technical Document (CTD) format, which includes 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 parameters, 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