ENGLISH

Regulatory Information

Total 4
No.
Key Stage
Regulation Type
Competent Authority
Regulation Title
4
Interim Safety Analysis, Monitoring, Audit
Enforcement Rule
Ministry of Food and Drug Safety (MFDS)
Rules on the Safety of Pharmaceuticals, etc.
3
Interim Safety Analysis, Monitoring, Audit
Law
Ministry of Food and Drug Safety (MFDS)
Pharmaceutical Affairs Act
2
Interim Safety Analysis, Monitoring, Audit
Ministerial Notification
Ministry of Food and Drug Safety (MFDS)
Regulation on Education for Clinical Trial Personnel and Designation of Training Institutions
1
Interim Safety Analysis, Monitoring, Audit
Ministerial Notification
Ministry of Food and Drug Safety (MFDS)
Regulation on the Operation of Risk Management Plans