Market Athorization Procedure for Regenerative Medicine [RM001] | N/A | 15 | 15,000 | | |
Technical Guidance for Quality, Non-Clinical Studies and Clinical Studies of Regenerative Medicine Products (Human Cell Processed Products) [RM002] | 6/27/2016 | 23 | 23,000 | | |
Checkpoint for Efficiant Regulatory Strategy Meeting for Regenerative Medicine Products: Quality [RM003] | 3/8/2013 | 10 | 10,000 | | |
Checkpoint for Efficiant Regulatory Strategy Meeting for Regenerative Medicine Products: Sterility test and myocoplasma test [RM004] | 1/17/2014 | 2 | 2,000 | | |
Checkpoint for Efficiant Regulatory Strategy Meeting for Regenerative Medicine Products: Non-clincal safety [RM005] | 3/8/2013 | 3 | 3,000 | | |
Key Points for the Submission of Initial Clinical Trial Notification of Regenerative Medicine Product (Powerpoint) [RM006] | N/A | 4 | 4,000 | | |