GUIDELINE FOR REGULATORY RELIANCE OF DECISIONS FROM REFERENCE REGULATORY AUTHORITIES
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- Create Date September 6, 2026
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GUIDELINE FOR REGULATORY RELIANCE OF DECISIONS FROM REFERENCE REGULATORY AUTHORITIES
The National Regulatory Reliance Guideline provides a framework for the Pharmacy and Poisons Board (PPB) to leverage trusted regulatory decisions and outputs from recognized regulatory authorities.
By reducing duplication of assessments and inspections, the Guideline helps optimize regulatory resources, improve efficiency, and accelerate access to quality-assured health products and technologies.
What the Guideline Enables
- Faster approvals through reliance on trusted regulatory assessments and inspections.
- Efficient use of resources by minimizing regulatory duplication.
- Stronger regulatory capacity through knowledge exchange and technical cooperation.
- Improved safety monitoring through regulatory information and data sharing.
- Greater regional cooperation and regulatory harmonization.
Built on Global Best Practice
The Guideline aligns with WHO Good Reliance Practices, the African Union Model Law, and regional initiatives under the EAC, IGAD, and African Medicines Agency (AMA).
It enables Kenya to benefit from trusted regulatory expertise while retaining full national regulatory authority and decision-making responsibility.
The Impact
Faster Access — Shorter regulatory timelines for quality-assured health products.
Greater Efficiency — Better use of regulatory expertise and resources.
Stronger Cooperation — Deeper collaboration across regional, continental, and global regulatory networks.
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