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Guidelines on Reliance Mechanisms for Marketing Authorization of Health Products and Technologies in Kenya

These guidelines, issued by the Pharmacy and Poisons Board (PPB), provide the framework for applying reliance mechanisms in evaluating and granting marketing authorisation for health products and technologies (HPTs). Through reliance, the PPB may base part or all of its regulatory decisions on prior evaluations conducted by trusted reference authorities or regional/international regulatory bodies, while retaining the authority for final approval.

Scope

Applies to all health products and technologies, including medicines, vaccines, biologics, and medical devices,submitted for registration in Kenya where reliance pathways are applicable.

Reliance Pathways

• Verification – confirms sameness of a product with one already approved by a reference regulatory authority.
• Abridged Review – relies on full or partial assessment reports from reference regulatory authorities to inform local decisions, evaluating the product under local conditions and regulatory requirements.
• Joint Assessment/Work-sharing – involves collaborative review with other regulators (e.g., AMRH, EAC-MRH, AMA, IGAD, EU-M4ALL, MAGHP).
• Recognition – accepts the regulatory decision of another authority either under mutual recognition agreements or unilaterally.

Recognized Reference Regulatory Authorities (RRAs):

The PPB recognizes and may rely on assessments from:

• World Health Organization (WHO) – Prequalification Programme, Collaborative Registration Procedure.
• Stringent Regulatory Authorities (SRAs) – such as the U.S. FDA, European Medicines Agency (EMA), Health Canada, Swissmedic, PMDA (Japan), TGA (Australia), and others recognized as SRAs.
• Regional Regulatory Mechanisms – including the East African Community Medicines Regulatory Harmonization (EAC-MRH) initiative and other African regulatory platforms.

Main Content

• Principles of Reliance – sovereignty, legal basis, transparency, competency, consistency, and universality.
• Health Products Framework – requirements for reliance applications, eligibility criteria for selecting reference authorities, and procedures for variations.
• Medical Devices and IVDs – reliance approaches adapted to device class and public health impact, requirements for reliance applications, eligibility criteria for selecting reference authorities
• Implementation – timelines, documentation standards, and mechanisms for post-approval changes.

Objective

To streamline regulatory processes, avoid duplication, and ensure timely access to safe, effective, and quality-assured health products and technologies in Kenya, while maintaining national regulatory independence. The guideline strengthens PPB’s regulatory capacity, aligns with global best practices, and supports attainment of Universal Health Coverage.

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