Regulatory Lifecycle Management of Solid Oral Dosage Forms in Nigeria and Kenya

Solid oral dosage forms (SODFs), including tablets and capsules, are the most commonly used pharmaceutical products worldwide, requiring effective regulatory oversight throughout their lifecycle to ensure quality, safety, and efficacy. This review compares the regulatory lifecycle management frameworks for SODFs in Nigeria and Kenya, focusing on pre-market authorization, post-approval variation management, pharmacovigilance, and marketing authorization renewal. Drawing on regulatory guidelines, legislative frameworks, and relevant literature, the review finds that both Nigeria’s NAFDAC and Kenya’s PPB have adopted internationally aligned regulatory approaches, including CTD-based submissions, GMP inspections, and post-marketing surveillance systems. Despite progress in regulatory maturity and regional harmonization efforts, challenges such as limited resources, regulatory backlogs, and underreporting of adverse drug reactions remain. The experiences of both countries provide valuable insights for strengthening regulatory systems and supporting effective medicine lifecycle management across Africa.

Nigeria and Kenya have made significant progress in aligning SODF regulatory practices with international standards across the product life cycle. However, challenges in implementation particularly in Nigeria persist while on going regional harmonization efforts present promising opportunity to strengthen regulatory efficiency and consistency in sub–Saharan Africa.