Comparative Evaluation of CTD Module 3 Requirements for Oral vs Ointment Formulations in the Kenyan Regulatory Framework

Kenya’s Pharmacy and Poisons Board (PPB) follows the Common Technical Document (CTD) format with adaptations under East African Community (EAC) guidelines and Climatic Zone IVb conditions. Variations in manufacturing science between oral and ointment formulations often result in different expectations and common gaps in CTD Module 3 (Quality). This study compared Module 3 requirements and dossier compliance for oral and ointment submissions to PPB through a retrospective review of dossiers, using a standardized rubric to evaluate adequacy of sections 3.2.S (drug substance) and 3.2.P (drug product). Oral dossiers demonstrated stronger compliance in manufacturing process (3.2.P.3) and product control (3.2.P.5), while ointment dossiers frequently showed deficiencies in pharmaceutical development (3.2.P.2) and stability studies under Zone IVb (3.2.P.8). Drug substance documentation was generally comparable, though variations in residual solvent control and polymorphic characterization were observed depending on source data. The most frequent critical gaps related to stability justification, microbial quality, and preservative efficacy. Overall, while Module 3 requirements are harmonized, dosage-form–specific expectations lead to recurring deficiencies. Targeted guidance and applicant checklists could help reduce regulatory queries, improve dossier quality, and shorten review timelines in Kenya.