In the ever-evolving landscape of global health, regulatory authorities are increasingly recognizing the transformative potential of “regulatory reliance” – the act whereby the regulatory authority in one jurisdiction takes into account and gives significant weight to assessments performed by another regulatory authority or trusted institution, or to any other authoritative information, in reaching its own decision. Kenya has firmly embraced this progressive approach, with the Pharmacy and Poisons Board (PPB) leading the charge since 2020.
“Regulatory reliance is essential for modern and efficient regulatory frameworks,” emphasized Dr. John M. Mwangi, representing the Kenya Association of Pharmaceutical Industry (KAPI). “Its accelerated adoption, particularly in the wake of the COVID-19 pandemic, has underscored the critical need for resource-optimizing strategies that maintain robust oversight without compromising safety and efficacy.”
Dr. James Mokoro – KAPI Chairperson
Dr. Beena Mahida – FKPM Representative
Dr. John Mwangi – KAPI Board Member
Dr. Ali Arale from the PPB’s Department of Drug Registration elaborated on the legal framework supporting reliance in Kenya, highlighting key provisions that enable the recognition of clinical trial decisions, pharmacovigilance data, and collaborative regulatory measures with regional and international partners.
“Kenya’s commitment to implementing reliance practices is evident in our collaborations with the World Health Organization, the African Medicines Regulatory Harmonization initiative, and other trusted authorities,” Dr. Arale explained. “This has allowed us to leverage assessments, share workloads, and establish clear timelines for application reviews – all with the aim of enhancing access to quality-assured health products for our population.”
Echoing these sentiments, Dr. Rim Mahmoud of the Egyptian Drug Authority (EDA) shared her country’s experiences in embracing reliance as a strategic approach to regulatory oversight. She emphasized the importance of “sameness of product” as a guiding principle, and discussed the EDA’s achievements in reaching WHO Maturity Level 3 and becoming a Transitional WHO Listed Authority.
Dr. Brayhan Kariuki, PPB representative
Angeline Achoka – Astrazeneca – leading a group discussion
Juliet Ouma – African Pharmaceutical Network leading a group discussion
“Reliance is not just about time-saving or sovereignty concerns,” said Dr. Mwangi. “It’s a holistic approach that allows regulatory authorities to optimize resources, harmonize processes, and focus their efforts where they are most needed – all while maintaining the highest standards of safety and efficacy.”
The Medical Technology Industry Association of Kenya (MEDAK) underscored the need for clear guidelines, streamlined submission infrastructure, and expanded reliance options – including for post-approval changes and medical device registrations. Improved inter-agency communication and capacity-building initiatives were also highlighted as crucial for strengthening the reliance framework.
As Kenya continues to refine its regulatory reliance practices, the insights and lessons shared by industry leaders and regulatory experts have provided a roadmap for success. By fostering greater collaboration, harmonization, and a shared commitment to public health, the country is poised to emerge as a regional trailblazer in the efficient and effective oversight of health products and technologies.
Below is a brief highlight of the workshop;