IFPMA worked with Clarivate to study how different countries and regions approach the regulation of post-approval changes (PACs) in biotherapeutic products.

The research compared PACs guidelines across 21 countries and regions in Latin America (LATAM), Asia-Pacific (APAC), and the Middle East and Africa (MEA) to the World Health Organization (WHO) Guidelines on changes on biotherapeutic products.

The findings reveal significant diversity in the level of convergence among countries and with the WHO, with a few notable trends.

Key recommendations

• Global regulatory convergence using a science and risk-based regulatory framework enables more efficient management of PACs, especially when specifically adapted to biologics (and other modalities)
• Establishing national or regional variation guidelines in line with international standards (e.g. WHO, ICH Q12) in terms of categorization, requirements and timelines allows predictability and consistency in the handling of changes without the need for additional local requirements
• Expanding reliance practices to include life cycle management will accelerate the approval of changes, facilitating patient access to innovative, high-quality, and safe products.