Global health authorities review and approval trends for CMC post approval changes 2018-2024

The approval and implementation of Chemistry, Manufacturing, and Control (CMC) post-approval changes (PACs) by global health authorities are often lengthy and unpredictable in terms of requirements and timeline, potentially leading to drug shortages and hindering innovation in product quality and manufacturing processes. This study analyzes the review and approval times for CMC PACs from 2018 to 2024, focusing on alignment with the World Health Organization (WHO) recommendations for a maximum six-month review period for PACs. The analysis reveals a positive trend towards shorter approval times, with significant improvements observed post-2019. However, inconsistencies remain, particularly in the classification and procedural processes of CMC PACs across different countries. The study underscores the need for global harmonization of PAC frameworks and the adoption of WHO reliance principles to enhance the predictability of and efficiency of CMC lifecycle management. These improvements are crucial for strengthening the global supply chain, fostering innovation in pharmaceutical manufacturing, and ultimately ensuring timely patient access to essential medications.