Guidance on Reliance for Regulatory Decision Making in Kenya

0. The attainment of Universal Health coverage (UHC) require that patients have access to quality – assured health products and health technologies. Pharmacy and Poisons Board is responsible for assuring the quality, safety and efficacy of medicinal products. To achieve this, a lot of resources is needed in terms of work force with necessary expertise, physical infrastructure, and financial investment. Strengthening regulatory systems for medicines and other health technologies has been critical priority for Pharmacy and Poisons Board as one way to achieve Universal Health Coverage.
1. While harmonization and convergence have been pursued for some years by PPB through Regional initiatives, such as, the East Africa Community Medicines Regulatory Harmonization (EAC-MRH), the recent Intergovernmental Authority on Development (IGAD) and the

MRH project under the African Medicines Regulatory Harmonization(AMRH), the use of reliance is an emerging trend as a strategy to bring efficiencies to regulatory systems and of interest for regulatory systems strengthening. These approaches are necessary due to globalization of markets, the emergency of complex health products and technologies, rapid evolution of regulatory science and increasing complexity of supply chain requirements.

3. The PPB definition of reliance is in line with that of WHO definition, where it is, “the act whereby the work done by the well-resourced NRA i.e. SRA is shared (e.g through assessment reports, QC laboratory reports and Inspection reports etc), While PPB uses this work according to its own scientific Knowledge and regulatory procedures to make independent final decision.
4. This guidance document is intended to assist the board and stakeholders in the pharmaceutical industry to implement a practical and scientific approach to Reliance Principles.