Description: A medicinal product, once granted its first marketing authorization approval, can remain on the market for more than 15 years or even longer. Over this life-cycle, manufacturing process will be improved and optimized, production materials and formulation may be modified, new safety and efficacy signals may be detected from its wide usage in clinical practice; amending the current approved labeling. Over the last five years, such post-approval changes or variations have increased by 45% per marketing authorization*. Before these changes can be implemented, they must meet specific requirements – ranging from a simple notification to a comprehensive review. This review process is frequently lengthy and often varies across different regulatory jurisdictions. Recently introduced international guidelines from the WHO (Annexes 3 & 4) and ICH Q12 therefore aim to encourage flexibility of regulatory review processes and adoption of a risk-based approaches categorization system for managing post-approval changes.
This presentation aims to describe the impact of these new guidelines on regulatory change management systems from both a manufacturer and regulatory agency perspective, in improving variation package submissions and facilitating better resource allocation for administrative and scientific marketing authorization variation review. This is presented through case studies and concrete examples of the application and interpretation of the guidelines, and the accompanying tools and approaches that may be applied.
*Based on Medicines for Europe data gathered on minimum of 18,000 MAs each year and over 5 years
