Drug Registration Requirement Process for Kenya and Saudi Arabia

The pharmaceutical regulatory frameworks in Kenya and Saudi Arabia ensure drug safety, efficacy, and quality. Understanding their registration processes is crucial for pharmaceutical companies seeking market entry. This study compares the drug registration requirements of both countries, focusing on regulatory authorities, dossier submission, approval timelines, and key challenges. A comprehensive review of regulatory guidelines from the Pharmacy and Poisons Board (PPB) of Kenya and the Saudi Food and Drug Authority (SFDA) was conducted. Although both countries align with ICH and WHO standards, differences exist in Common Technical Document (CTD) vs. eCTD submission formats, local testing requirements, and approval timelines.