Global Clinical Trials: Navigating South Korea’s Regulatory Landscape for Multinational Studies, from IND Application to NDA Approval

EC/IRB procedure

There are centralized IRB and individual IRB in institution. But many sites conduct IRB’s review itself

Procedure for protocol changes, CMC changes, premature termination etc. during the clinical trial

There is a criterion for what changes is needed an approval from MFDS or not. If Protocol changes or CMC changes are substantial and are likely to have a significant impact on the safety of the subjects or reliability of the study, the sponsor should submit amendments to MFDS and IRB. Also, the sponsor should notify some kinds of non-substantial amendments to MFDS. 

In the case of No clear regulation for this, but from current practice, once clinical trial is approved, there is no official channel to submit the CMC changes, protocol changes during the clinical trial. Significant change needs another CTP application, and the minor change could submit for EC approval. premature(early) termination, the sponsor must notify the end of the trial and the reason expeditely.

Adverse drug reaction reporting during clinical trial

The sponsor must notify all ADRs that are both serious and unexpected to MFDS, investigators and IRB expeditely. The sponsor should notify MFDS of findings that could affect adversely the safety of subjects, impact the conduct of the trial, or alter the IRB’s approval/favourable opinion to continue the trial.

Investigational drug labelling (requirements and language)

The sponsor is responsible for labelling of the investigational Drugs. The labels must be written in Korean. The labels should include code (general name), lot number, the period of use (expiry date or re-test date), storage conditions, name & address of the sponsor and “for clinical trials use only”.