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Guidelines on Submission of Documentation for Emergency Use & Compassionate Use Authorization (Eua/Cua) of Health Products and Technologies

Issued by the Pharmacy and Poisons Board (PPB), this guideline is intended to provide general considerations and guidance on content and format for required information for regulatory submission of Health products and Technologies for Emergency use/compassionate use authorization in Kenya.

It sets requirements for Emergency Use Authorization (EUA) and Compassionate Use Authorization (CUA), ensuring access to potentially life-saving products while maintaining appropriate standards of quality, safety, and efficacy.

Scope

Applies to all health products and technologies  that may be considered for use under emergency or compassionate access pathways in Kenya. This guideline does not cover off-label use.

Available Authorization Pathways

• Emergency Use Authorization (EUA)– granted for unregistered products in response to declared public health emergencies, based on preliminary evidence of quality, safety, and efficacy.
• Compassionate Use Authorization (CUA)– allows access to unregistered products for individual patients or groups with serious/life-threatening conditions where no satisfactory alternatives exist.

Main Content

• Eligibility Criteria– types of products and conditions for consideration under EUA or CUA.
• Submission Requirements– dossier format, data requirements (quality, safety, efficacy), and supporting documentation from reference authorities.
• Evaluation & Decision-Making Process– accelerated review timelines, expert consultation, and risk–benefit assessment.
• Responsibilities of Applicants– ensuring completeness, accuracy, and timely submission of follow-up data.
• Post-Authorization Conditions– monitoring, adverse event reporting, and transition to full registration where applicable.

Objective

The guideline ensures a transparent, expedited, and science-based process for granting emergency or compassionate use of unregistered health products in Kenya, balancing the urgent need for access with the protection of public health.

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