Evaluation of Health Products’ Regulatory Review Process in Kenya: Challenges and Opportunities

The processes by which countries regulate medical products and health technologies have a profound impact on access to high-quality vaccines, devices, diagnostics, and drugs, more so to those who need them most. The growth of the health industry around the globe has increased scrutiny by governments and a need to strengthen regulatory authorities to ensure that the markets were distributing safe health products. While critical, stringent scrutiny and complex regulations may slow processes, erecting bumps, casting a shadow on the intended goodwill of the regulatory authorities. Global trends and the need to faster and efficient systems have continued to pile pressure on various National Regulatory Authorities (NRAs), of all sizes and capacities. The growth of the health industry and increased categories of medical categories have further added the volumes for applications to licensing and regulatory authorities, yet, the need to maintain safety has remained paramount