Consideration of a review of the Clinical Research Law

• Published in: Transactions of Japanese Society for Medical and Biological Engineering Vol. Annual59; no. Abstract; p. 200
• Main Authors: Yoshioka, Kyoko, Fujimaki, Hisako, Kawabata, Kensuke, Nishikata, Shuma, Nomura, Yumiko, Kasamatsu, Junya
• Format: Journal Article
• Language: Japanese
• Published: Japanese Society for Medical and Biological Engineering 2021; 公益社団法人 日本生体医工学会
• ISSN: 1347-443X; 1881-4379
• DOI: 10.11239/jsmbe.Annual59.200

The Clinical Research Law was enacted for the improvement of health and hygiene by promoting the clinical research through ensuring the credibility of clinical research.The supplementary provisions of the law stipulate that a review shall be conducted within five years after the law comes into effect. A review was initiated at the Clinical Research Subcommittee of the Council for Health Sciences in January of this year. Specific clinical research covers medical devices that have not been approved, certified, or notified under the Pharmaceutical and Medical Devices Law. On the other hand, risks of medical devices are various, and medical devices are to be constantly improved and upgraded. While maintaining reliability, and giving consideration to ensuring the safety of study subjects, a review will be conducted to promote clinical research by increasing international consistency and reducing the burden of administrative procedures that do not affect the essence of the trial.