ENGLISH

Regulatory Information

Total 12
No.
Key Stage
Regulation Type
Competent Authority
Regulation Title
12
Protocol development
Enforcement Decree
Ministry of Food and Drug Safety (MFDS)
Enforcement Decree of the Pharmaceutical Affairs Act
11
Protocol development
Guidelines
Ministry of Food and Drug Safety (MFDS)
A casebook summarizing supplementary information frequently requested by the Ministry of Food and Drug Safety (MFDS)
10
Protocol development
Ministerial Notification
Ministry of Food and Drug Safety (MFDS)
Bioequivalence Test Standards for Drugs, etc.
9
Protocol development
Ministerial Notification
Ministry of Food and Drug Safety (MFDS)
Good Laboratory Practice (GLP)
8
Protocol development
Ministerial Notification
Ministry of Food and Drug Safety (MFDS)
Regulation on Approval, Implementation and Management of Digital Medical Device Clinical Trials
7
Protocol development
Ministerial Notification
Ministry of Food and Drug Safety (MFDS)
Regulation on Clinical Trial Plan Approval
6
Protocol development
Ministerial Notification
Ministry of Food and Drug Safety (MFDS)
Regulation on Preliminary Review of Medical Products
5
Protocol development
Ministerial Notification
Ministry of Food and Drug Safety (MFDS)
Regulation on the Designation of Orphan Drugs
4
Protocol development
Ministerial Notification
Ministry of Food and Drug Safety (MFDS)
Standards and Test Methods for Biologics
3
Protocol development
Ministerial Notification
Ministry of Food and Drug Safety (MFDS)
Standards for Pharmacological Testing of Drugs, etc.