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Guidelines on Submission of Documentation for Compassionate Use Authorization (CUA) of Health Products and Technologies

Introduction:

This guideline, developed by the Pharmacy and Poisons Board (PPB), establishes a system to facilitate patient access to unregistered health products still undergoing clinical trials, intended for those with serious, rare, or life-threatening conditions who are not eligible to participate in Clinical Trials.

Scope:

The guideline applies to health products and technologies that may be considered for compassionate use outside of clinical trials. Eligible products include medicines, vaccines, blood and biotherapeutics, medical devices and In-vitro diagnostics.

CUA is intended for individual patients or subpopulations who face urgent medical needs and are not eligible to participate in clinical trials. Importantly, compassionate use is not a substitute for clinical research and should not delay or replace ongoing trials. Instead, it serves as a controlled, exceptional measure to address unmet needs.

Main Content:

The guideline outlines:

• Eligibility criteria for candidate products and conditions under which CUA may be granted.
• Application process including minimum information requirements, cover letters, consent forms, and supporting documentation.
• Regulatory review and decision-making steps, with timelines defined under PPB’s service charter.
• Post-authorization obligations such as pharmacovigilance, safety monitoring, and reporting of serious adverse events.
• Termination provisions clarifying that authorizations are one-off and renewable only under set conditions

Through this framework, the PPB strengthens Kenya’s capacity to balance patient needs with regulatory standards, ensuring that compassionate access is provided responsibly, ethically, and in line with international best practices.

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