• Version
• Download 3288
• File Size 644.43 KB
• File Count 1
• Create Date February 9, 2022
• Last Updated August 25, 2025

Guidelines on submission of documentation for registration of Biotherapeutic products

These guidelines, issued by the Pharmacy and Poisons Board (PPB) under the Ministry of Health, Kenya, provide requirements for the registration and market authorisation of biotherapeutic products. They are intended for applicants preparing product dossiers, ensuring compliance with standards of quality, safety and efficacy.

Scope

The guidelines apply to biologically active protein products (including those prepared by recombinant DNA technology) intended for the treatment or diagnosis of human diseases. They exclude whole blood, cellular blood components, and protein products for in vitro diagnostics.

Main Content

• Administrative & Product Information– outlines administrative and product information requirements includingapplication forms, product characteristics, labelling, packaging, GMP/GCP/GLP certificates, regulatory status in other jurisdictions, and environmental risk assessment.
• Overviews & Summaries– consolidated quality, nonclinical and clinical summaries, with risk–benefit evaluations.
• Quality (Chemistry, Manufacturing & Controls)– requirements for drug substance and product, manufacturing processes, controls, validation, specifications, container systems, and stability data.
• Nonclinical Studies– pharmacology, pharmacokinetics, and toxicology results.
• Clinical Studies– efficacy, safety, immunogenicity, dosage justification, and overall benefit–risk analysis.
• Post-Marketing Surveillance– obligations for monitoring safety and efficacy after product registration.

Objective

To provide a transparent and harmonized framework for the registration of biotherapeutic products in Kenya, ensuring they meet international standards of safety, quality, and efficacy. The guideline aims to protect public health while facilitating access to essential biotherapeutics.

Attached Files