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

This Guidelines provides guidance on the modalities, processes, and procedures employed by the Pharmacy and Poisons Board (PPB) to implement reliance and/or utilize relevant Marketing Authorization (MA) decisions, reports, or information from other National Regulatory Authorities (NRAs), regional, and international bodies.

The PPB, recognizing the principles of Good Reliance Practices as outlined by the World Health Organization (WHO), strives to strengthen its regulatory system through efficient and effective reliance strategies. This approach enables the PPB to leverage the expertise and resources of other competent authorities while focusing its efforts on value-added activities crucial for the Kenyan market, such as, Vigilance by monitoring the safety and effectiveness of medicines post-market, Market Surveillance by ensuring the quality and authenticity of HPTs in the Kenyan market, Local Manufacturing and Distribution by supporting and overseeing the growth of local pharmaceutical industries, and Quality Control that enhances the quality assurance of HPTs through robust laboratory testing and inspection programs.

Reliance approaches facilitate timely access to safe, effective, and quality- assured HPTs for the Kenyan population. They are particularly valuable during public health emergencies, enabling rapid regulatory responses. In today's dynamic global healthcare landscape, NRAs face numerous challenges, including: globalization of markets, rapid advancements in health products and technologies, evolving regulatory science, Complex supply chains and growing public expectations and resource constraints including limited human, financial, and infrastructural resources.

These challenges underscore the critical need for international cooperation to ensure the safety, quality, and efficacy/effectiveness of HPTs in Kenya. By embracing enhanced collaboration and reliance strategies, the PPB aims to:

a) Optimize resource utilization by avoiding unnecessary duplication of efforts and focus resources on areas of greatest need.

b) Leverage on international expertise by gaining access to the knowledge and experience of other competent authorities.

c) Facilitate timely access to medicines by ensuring timely availability of essential and innovative medicines for the Kenyan population

d) Strengthen regulatory capacity by enhancing the PPB's scientific and technical capabilities through knowledge exchange and training.

The attainment of Universal Health Coverage (UHC) in Kenya hinges on the availability of quality-assured medicines and health technologies. PPB is committed to strengthening its regulatory system through strategic reliance partnerships to ensure access to quality, safe, efficacious medicines and effective medical devices and IVD’s for all Kenyans.

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