If the rules described in the GCP are violated, legal action will be taken against the target company or medical institution (discontinuation of clinical trials, suspension of sales of new drugs, etc.). Specific examples of rules stipulated by GCP

・When conducting a clinical trial, notify the government of the details of the clinical trial.

・Before conducting a clinical trial, an IRB (Institutional Review Board) should investigate safety, efficacy, and ethics.

・ Only subjects who have given written consent

・If a serious side effect is found in conducting a clinical trial, it must be reported to the government.