Consideration of a review of the Clinical Research Law
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 effec...
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| Published in | Transactions of Japanese Society for Medical and Biological Engineering Vol. Annual59; no. Abstract; p. 200 |
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| Main Authors | , , , , , |
| 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 |
| Online Access | Get full text |
| ISSN | 1347-443X 1881-4379 |
| DOI | 10.11239/jsmbe.Annual59.200 |
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| Abstract | 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. |
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| AbstractList | 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.
臨床研究法は、臨床研究の実施に際しての手続きや制度を定めることにより、臨床研究に対する信頼性の確保を図ることを通じてその実施を推進し、保健衛生の向上に寄与することを目的に、平成30年4月から施行された。法律の付則に、法律の施行の状況、臨床研究を取り巻く状況の変化等を勘案し、施行後5年以内に見直しを行うこととされており、本年1月の厚生科学審議会臨床研究部会において見直しに着手し、以降、検討を継続している。臨床研究法において規制の対象となる特定臨床研究は、医薬品医療機器法に基づく承認・認証・届出がなされていない医療機器や、承認、認証又は届出とは異なる使用方法で用いる医療機器を対象としている。一方で、医療機器には多種多様な品目が存在し、人に対するリスクも様々であること、既存の製品の改良・改善が絶え間なく行われるなどの特徴があり、特定臨床研究の対象にリスクの低い医療機器や既承認の医療機器と性能上大きな違いのない医療機器も含まれる点等について、意見が寄せられている。法の目的である信頼性の確保を保持し、被験者の安全性確保に配慮しつつ、国際整合性を高め、試験の本質に影響しない事務手続きの負担軽減等により、臨床研究の推進が図られるよう見直しの検討を進めていく。 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. |
| Author | Yoshioka, Kyoko Nishikata, Shuma Nomura, Yumiko Fujimaki, Hisako Kawabata, Kensuke Kasamatsu, Junya |
| Author_FL | 笠松 淳也 川畑 研介 藤巻 寿子 野村 由美子 西方 修馬 吉岡 恭子 |
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| Title | Consideration of a review of the Clinical Research Law |
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