The current Act stipulates the terms to be observed when a person who intends to conduct a clinical trial and an institute that conducts clinical trials, and it also stipulates the sanctions to be imposed when such terms are violated.
However, since there is no provision for the terms of compliance that should be observed by persons responsible for conducting clinical trials and no sanctions if they violate the provision, it has been pointed out that there are limitations in securing the safety and ethics of clinical trials.
Therefore, the amendment aims to stipulate the terms to be observed when a person responsible for conducting clinical trials conducts a clinical trial, such as the protection of test subjects of the clinical trial, and to allow the head of an institute for clinical trials to change the person responsible for conducting the clinical trial or exclude him/her from the clinical trial for a certain period if he/she violates the terms specified in the newly inserted Articles (Article 34-2 (4) and Article 76-2 (3) newly inserted).

Article 34-2 (Designation, etc., of Institutes for Clinical Trials, etc.) (4) A person responsible for conducting clinical trials of an institute for clinical trials shall observe the items prescribed by Ordinance of the Prime Minister, such as the protection of test subjects of a clinical trial.
Article 76-2 (Revocation, etc., of the Designation of Institutes for Clinical Trials, etc.) (3) If a person responsible for conducting a clinical trial in an institute for clinical trials does not observe the terms of compliance of Article 34-2 (4), the Minister of Food and Drug Safety may order the head of the institute for clinical trials to change the person responsible for conducting the trial or exclude him/her from the clinical trial for a maximum period of nine months.