PPB to Introduce Reforms in Health Products Manufacturing Sector

Kenya, April 24, 2026 - The Pharmacy and Poisons Board has announced it is undertaking major reforms in the country’s health products manufacturing sector as part of broader efforts to strengthen the quality and efficiency of the country’s healthcare system.

According to the Board’s Acting CEO, Ahmed Mohamed, PPB has initiated measures to support local manufacturers through preferential fees and expedited evaluation timelines of between three and six months.

 Mohamed also revealed that the Board is in the process of implementing mandatory renewal of marketing authorisations, intended to ensure that only compliant products remain on the Kenyan market.

 The  CEO revealed this on Thursday during a meeting with the  Indian High Commissioner to Kenya, Adarsh Swaika, which aimed to discuss regulations of Health Products and Technologies (HPTs) in the country.

“The discussions focused on ongoing reforms aimed at ensuring that all HPTs in circulation meet the required standards of quality, safety, and efficacy,” PPB stated.

“The engagement reaffirmed the strong and growing collaboration between Kenya and India in advancing access to quality-assured, safe, and effective health products,” it added.

 The two sides also stressed the need for reinforcing other oversight mechanisms, including the Good Manufacturing Practice (GMP) inspections for manufacturing sites to maintain the integrity of the country’s pharmaceutical supply chain.

 The announcement comes days after the Board released a new draft guidance targeting technologies used in the country's health ecosystem, including Artificial Intelligence, as well as other mobile health tools.

 PPB maintained that the draft will be fundamental in ensuring that software-driven medical technologies meet standards of safety, quality, and performance before entering the market.

The Board has already engineered guidelines that will regulate Medical Device Software (MDSW), including Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD).

The framework aligns Kenya with global standards, including those of the International Medical Device Regulators Forum, and draws from national policies such as the Kenya National Cybersecurity Strategy (2022–2027), the Digital Health Act (2023), and the Kenya AI Strategy (2025–2030), according to PPB.

“The move reflects the growing role of standalone software in healthcare, performing functions such as diagnosis, monitoring, and treatment,”  Mohamed said.