Policy & Advocacy
We leverage our standing relationships within the policy environment to engage with and inform policies that support an enabling business environment in the health and pharmaceutical industry. Through the dedicated efforts of the working committees, KAPI has provided timely feedback on varied regulations and guidelines influencing the operational requirements for pharmaceutical and medical devices areas of interest.
Some of our standing relationships that have helped us shape and inform policies toward an enabling environment in the health and pharmaceutical industry include:
01.
Africa Medicines Agency
KAPI has continually called for harmonization of regulations to increase product penetration in Africa. The Association has delved into addressing related challenges to advance regulatory harmonization and convergence. This has been through its appointment to the Africa Engagement Committee as a council member and as a member of the Africa Medicines Agency task force, as well as working with partners such as PATH.
This collaboration has culminated in Kenya’s ratification and deposit of instruments in support of the Africa Medicines Agency—an important strategic step for Kenya
02.
WHO Global Benchmarking Tool Maturity Level 3
Effective regulatory systems are an essential component of health systems and contribute to desired public health outcomes and innovation. As mandated by WHA Resolution 67.20 on Regulatory System Strengthening for medical products, WHO objectively evaluates regulatory authorities using the GBT. Kenya embarked on this journey in 2023 through PPB. This process included the involvement of industry players such as KAPI in reviewing guidelines and processes. Strategically, Kenya’s elevation to maturity level 3 will open up the market for the manufacture of complex molecules such as vaccines, aligning with the aim for Africa to become self-reliant.
KAPI played a key role in the evaluation of 16 guidelines and negotiated with PPB for an extended implementation date for renewals that ensured that business was not disrupted.
03.
Regulations, Legislations, and guidelines
Through the dedicated efforts of the working committees, KAPI has provided timely feedback on varied regulations and guidelines influencing the operational requirements for pharmaceutical and medical devices areas of interest. KAPI, working with its committees, has developed position papers on emerging guidelines and policies on healthcare financing, parallel importation, regulatory system strengthening, the NHIF Bill, Finance Bill, Kenya Drugs Authority Bill, and the Extended Producer Responsibility Act, etc.
Some of the notable position papers submitted in the previous year include:
- Quality of Health Care and Patient Safety Bill 2025
- Position Statement on Draft Guidelines for Renewals of Medicines and Vaccines
- Position Statement on Draft Guideline For Submission of Variation Applications For Registered Biotherapeutic Products
- KAPI Recommendations on the Guideline for Submission of Variation Applications for Registered Human Products
A worthy success to note was that KAPI was key in influencing the revision of the advertisement and promotion guidelines in Kenya, resulting in guidelines aligned with the self-regulatory KAPI Code of Practice. KAPI’s efforts in championing responsive policies for an enabling pharmaceutical and biotechnology industry in Kenya have been evident through its collaboration with various stakeholders, led by the Board and its committees. The dedication to patient-centric approaches and unwavering commitment to excellence have served as the cornerstone of our progress.