Due to the uncovering of clinical research misconduct in the past few years, the Clinical Research Act was enacted on April 7, 2017, and was promulgated on April 14, 2017. Under this act, those who conduct Specified Clinical Research ("SCR") must (i) comply with the clinical research guidelines that will be made by the Ministry of Health, Labour and Welfare, which will regulate, among others, monitoring activities and the auditing and management of conflicts of interest, and (ii) obtain informed consent, protect personal data, keep records, hold hearings with certified clinical research ethics committees relating to clinical research plans, and report adverse events. SCR is defined as clinical research sponsored by manufacturers of drugs, medical devices, or human cell therapy and gene therapy products ("Drugs, etc.") and clinical research related to the Drugs, etc. of those companies, or clinical research to study the Drugs, etc. that have not been approved under the Pharmaceutical and Medical Device Act ("PMD Act") or off-label uses of the Drugs, etc. However, any clinical trial regulated under the PMD Act is excluded from the definition of SCR. In addition, under the Clinical Research Act, manufacturers of Drugs, etc. shall be obligated to execute contracts to sponsor SCR and to disclose sponsorship information. Future ministerial ordinances will specify what sponsorship information must be disclosed, and these future developments should be closely monitored. This act will come into force within one year from the date of promulgation.
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