약학회지
YAKHAK HOEJI
ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)

Table. 4.

Table. 4.

Types of RS development programs

Strategy Country Regulatory body Center/Program
Regulatory body supports designated academia/industry U.S. FDA CERSI

Partnership for research U.S. NIH NIH Common Fund
FDA Harvard-MIT CRS, BAA

Network of Regulatory Bodies EU EMA, National agency, EC EMRN
Netherland MEB RSNN
Australia TGA RSN

Regulatory science center established by government agency Japan PMDA RS Center

Government agency dedicated for RS Australia/Newzealand FSANZ FSANZ

Regulatory science center established in a University Denmark DKMA CORS
Singapore HSA CoRE

Individual University Programs U.S. FDA University of Rochester Advanced certificate in Regulatory Science
University of St.Thomas
M.S. in Regulatory Science
Texas A&M University Regulatory Science in Food Sysems Graduate Program

FDA: Food and Drug Administration, CERSI: Center of Excellence in Regulatory Science and Innovation, EMA: European Medicines Agency, CRS: Center for Regulatory Science, BAA: Broad Agency Announcement, EMRN: European Medicines Regulatory Network, MEB: Medicines Evaluation Board, RSNN: Regulatory Science Network Netherlands, TGA: Therapeutic Goods Administration, RSN: Regulatory Science Network, PMDA: Pharmaceuticals and Medical Devices Agency, FSANZ: Food Standards Australia New Zealand, DKMA: Denmark Medicines Agency, CORS: Copenhagen Center for Regulatory Science, HSA: ,CoRE:Centre of Regulatory Excellence

Yakhak Hoeji 2021;65:335-43 https://doi.org/10.17480/psk.2021.65.5.335
© 2021 Yakhak Hoeji