P332/P333: Advancing Post-Market Approval through Global Collaboration: Evidence from Taiwan
Poster Presenter
Meng-Hsiu Wu
Deputy Director, Division of Medicinal Products
Taiwan's Food and Drug Administration (TFDA) Taiwan
Objectives
To provide practical evidence of the benefits of regulatory reliance and the application of global collaboration in health product approvals.
Method
Qualitative analysis of multiple post-market change application cases in Taiwan facilitated by the Accumulus platform, investigating the transition from sequential to synchronized workflows.
Results
The submission of a harmonized global package enabled the Taiwan Food and Drug Administration (TFDA) to leverage evaluation reports from reference agencies more effectively, fostering a high degree of regulatory reliance. Furthermore, the implementation of a centralized digital platform facilitated the real-time resolution of technical queries, which reduced communication lag between stakeholders. This streamlined data exchange replaced traditional sequential workflows with a more synchronized approach, ultimately resulting in a more predictable and accelerated review process for post-market changes in Taiwan.
Conclusion
These case studies demonstrate that global collaboration and centralized digital infrastructure are powerful catalysts for regulatory innovation. By navigating post-market changes through a shared platform, these results validate that Taiwan is optimally positioned to adopt regulatory reliance frameworks. Implementing such collaborative models not only reduces the administrative burden on both sponsors and regulators but also ensures that patients in Taiwan receive faster, more reliable access to updated health products.
