Abstract
Abstract
Purpose
To assess progress in regulatory convergence among APEC economies using updated Key Performance Indicators (KPI) and to identify opportunities for strengthening reliance and work sharing, while informing future Phase 2 KPI development. Our work describes the adoption of regulatory best practices as defined by KPI over a period covering 2019, 2020 and 2025. Across the regulatory KPIs, the strongest areas of progress are information sharing and mutual recognition agreement, achieving convergence rates of 91% (19/21) and 62% (13/21), respectively. However, implementation of best practices remains uneven. Specifically, 35% of economies that meet the KPI of permitting multiple sites under a single license continue to treat the addition of a new manufacturing site as a new product license. This undermines the intended efficiency gains and perpetuates supply inflexibility. Similar inconsistencies are observed in the application of reliance throughout the regulatory lifecycle, including continued re-testing and residual dependence on Certificates of Pharmaceutical Product (CPPs). These gaps highlight the need for more consistent and holistic implementation of convergence practices.
Methods
A KPI-based cross-sectional analysis was conducted using survey data of Phase 1 KPI from national regulatory authorities across all 21 APEC economies, supplemented by documentary review and independent validation.
Results
Substantial progress was observed in information sharing, mutual recognition agreements, acceptance of Good Manufacturing Practice (GMP) certificates, and removal of CPP requirements, while limited improvement was noted in waiving re-testing and consistent lifecycle reliance. Adoption of reliance pathways and multisite licensing increased, but gaps remain in harmonized implementation and supply flexibility/continuity/interoperability. Across indicators, adoption of convergence practices consistently exceeded effective implementation: economies meeting an indicator frequently retained procedural requirements that limited the intended efficiency gains.
Conclusions
APEC economies have advanced regulatory convergence through reliance and collaboration, yet further gains will require aligning best practices and expanded lifecycle reliance and scaled work-sharing mechanisms. APEC seeks to advance regulatory convergence through strengthened capacity building and the implementation of Phase 2 KPIs which are currently in development. Future Phase 2 KPI development may also provide an opportunity to consider broader areas such as pharmacovigilance, supply chain security, digital regulatory systems, and coordinated oversight of internet-based risks, while ensuring the acceleration of patient access to safe, quality, and effective medical products.