ENGLISH

Regulatory Information

Total 7
No.
Key Stage
Regulation Type
Competent Authority
Regulation Title
7
Study Start-up, Site Activation
Enforcement Decree
Ministry of Health and Welfare (MOHW)
Enforcement Decree of the Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Biopharmaceuticals
6
Study Start-up, Site Activation
Enforcement Rule
Ministry of Food and Drug Safety (MFDS)
Rules on the Safety and Support of Advanced Biopharmaceuticals
5
Study Start-up, Site Activation
Law
Ministry of Health and Welfare (MOHW)
Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Biopharmaceuticals
4
Study Start-up, Site Activation, Conducting Study
Law
Ministry of Health and Welfare (MOHW)
Bioethics and Safety Act
3
Study Start-up, Site Activation
Ministerial Notification
Ministry of Food and Drug Safety (MFDS)
Long-term Follow-up Management Standards for Advanced Biopharmaceuticals
2
Study Start-up, Site Activation
Ministerial Notification
Ministry of Food and Drug Safety (MFDS)
Regulation on Product Approval and Review of Advanced Biopharmaceuticals
1
Study Start-up, Site Activation
Ministerial Notification
Ministry of Food and Drug Safety (MFDS)
Regulation on the Designation of Clinical Trial Institutions for Drugs, etc.