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Guidelines on Submission of Documentation for Emergency Use Authorization (EUA) Of Health Products And Technologies

Introduction:

This guideline, developed by the Pharmacy and Poisons Board (PPB), provides a comprehensive framework, for regulatory submission, evaluation, and authorization of Health products and Technologies for Emergency use in Kenya.

Unlike routine product registration, EUA provides a risk-based, expedited pathway for products that address urgent threats such as pandemics, epidemics, or chemical, biological, radiological, and nuclear incidents.

Scope

The guideline applies to all stakeholders including manufacturers, importers, local technical representatives, and national health programs seeking EUA for products in Kenya. Eligible products include therapeutics, vaccines, blood products, biotherapeutics, in-vitro diagnostics, and critical medical devices. EUA is granted only where the potential benefits outweigh the risks (based on preliminary evidence of quality, safety, and efficacy), and where no registered alternatives exist.

Main Content

• Eligibility Criteria– types of products and conditions for consideration under EUA
• Phases of EUA: pre-emergency planning, emergency phase authorization, and post-authorization safety monitoring
• Submission Requirements – required dossier format, cover letter, supporting data (quality, safety and efficacy), and regulatory pathways (full assessment, abridged evaluation, or reliance on WHO/Reference Regulatory Authorities)..
• Evaluation & Decision-Making Process – accelerated review timelines, expert consultation, and risk–benefit assessment.
• Regulatory oversight and transition: provisions for pharmacovigilance, post-market surveillance, continued data submission, and transition to full registration where applicable.

By establishing clear rules for expedited access while maintaining safeguards for quality, safety, and efficacy, this guideline strengthens Kenya’s regulatory preparedness and resilience. It ensures that, in times of crisis, the public can rapidly access life-saving health products and technologies without compromising on regulatory standards.

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