Taiwan FDA hosts “2025 APEC Good Registration Management & Medical Devices Regulatory Science Center of Excellence Workshop”

To promote regulatory convergence across the Asia-Pacific region and enhance the quality and efficiency of drug registration management and medical device regulatory science, the Taiwan FDA organized the 2025 APEC Good Registration Management (GRM) & Medical Devices (MD) Regulatory Science Center of Excellence (CoE) Workshop from August 26 to 28. This year’s workshop was endorsed by the APEC Regulatory Harmonization Steering Committee (RHSC) as an official training program. The GRM session brought together nearly 20 experts from the European Medicines Agency (EMA), Japan Pharmaceuticals and Medical Devices Agency (PMDA), the D.K. Kim International Center for Regulatory Science at the University of Southern California (USC), and experts from Taiwan, including the Center for Drug Evaluation (CDE), the Asia Partnership Conference of Pharmaceutical Associations (APAC), and the International Research-Based Pharmaceutical Manufacturers Association (IRPMA). At least 70 participants from multiple APEC member economies, sharing best practices on good registration management and discussing topics such as accelerated approvals for medicines addressing unmet medical needs and combinatio...