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

enhance the quality and efficiency of drug registration management and medicaldevice regulatory science, the Taiwan FDA organized the 2025 APEC GoodRegistration Management (GRM) & Medical Devices (MD) Regulatory ScienceCenter of Excellence (CoE) Workshop from August 26 to 28. This year’s workshop was endorsed by the APEC Regulatory HarmonizationSteering Committee (RHSC) as an official training program. The GRM sessionbrought together nearly 20 experts from the European Medicines Agency (EMA),Japan Pharmaceuticals and Medical Devices Agency (PMDA), the D.K. KimInternational Center for Regulatory Science at the University of SouthernCalifornia (USC), and experts from Taiwan, including the Center for DrugEvaluation (CDE), the Asia Partnership Conference of Pharmaceutical Associations(APAC), and the International Research-Based Pharmaceutical ManufacturersAssociation (IRPMA). At least 70 participants from multiple APEC membereconomies, sharing best practices on good registration management anddiscussing topics such as accelerated approvals for medicines addressing unmetmedical needs and combination products. The workshop emphasized interactivelearning to foster collaboration and...