Turning complex post-approval changes in biological products into actionable regulatory insight
The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) represents the innovative, research-based pharmaceutical industry. Through its engagement with organizations including the United Nations, WHO, WIPO, and WTO, IFPMA helps advance policies that support innovation, access to medicines, pandemic preparedness, and better health outcomes worldwide.
Regulatory convergence was identified by IFPMA as a key enabler of regulatory reliance. To support this priority, Clarivate was engaged to assess how Post-Approval Changes, or PACs, guidelines for biological products align across selected markets and how those requirements compare with existing WHO guidance for biologics.
Read the case study to learn how Clarivate developed a clear, evidence-based framework to achieve this and:
- Compared PAC legislation and guidance across 22 markets in the EU, MEA, LATAM and APAC
- Benchmarked requirements against WHO guidelines
- Created actionable intelligence to better understand where regulatory approaches are aligned, where gaps remain and how greater convergence could support more consistent, efficient post-approval change management for biological products
