New Governmental Regulatory System for Stem Cell-Based Therapies in Japan
New Governmental Regulatory System for Stem Cell-Based Therapies in Japan
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DOI：
10.1177/2168479014526877
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发表时间：
2014-11-01
影响因子：
1.5
通讯作者：
Sahara, Yasuyuki
中科院分区：
文献类型：
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作者：
Hara, Akinori;Sato, Daisaku;Sahara, Yasuyuki
使用干细胞的再生医学有望为受损组织的替换或修复提供工具，从而为治疗许多无法有效治疗的疾病提供可能性。为了促进再生医学的发展和获得，重要的是要在加速提供创新疗法和确保安全性和有效性的适当步骤之间取得平衡。虽然大多数发达国家对涉及干细胞的临床试验和医疗有各种监管框架，但日本国会最近同时通过了《再生医学安全法》和《修订药事法》。根据前一项法案，这些医疗技术根据其对人类健康的预期潜在风险分为三类，并确定了属于每一类的具体程序。此外，该法还允许医疗机构委托符合厚生劳动省规定要求的机构外业务机构（甚至外国机构）进行细胞处理，目的是从早期阶段促进学术界和产业界之间的合作。根据后一项法律，再生医学的治疗产品被定义为与药品和医疗器械不同的产品，使再生医疗产品能够比以前的制度更早地获得有条件的、有时限的上市许可。再生医学的新法律的框架有望实现发展和促进再生医学的目标，旨在及时提供安全有效的治疗和产品。
Regenerative medicine using stem cells is expected to provide tools for the replacement or repair of damaged tissues, opening up the possibility of treating many diseases that cannot otherwise be effectively treated. To promote the development of and access to regenerative medicine, it is important to take a balance of expedited provision of innovative therapies and appropriate steps to ensure safety and efficacy. While most developed countries have various regulatory frameworks for clinical trials and medical treatments involving stem cells, the Act on the Safety of Regenerative Medicine and the Revised Pharmaceutical Affairs Law have recently been simultaneously passed by the Japanese Diet. According to the former act, these medical technologies are categorized into 3 classes depending on their anticipated potential risk to human health, and the specific procedures falling into each class are determined. In addition, the act enables medical institutions to commission cell processing by business facilities outside the institution (even foreign facilities) that fulfill the requirements set out by the Ministry of Health, Labour and Welfare, with the aim to promote collaboration between academia and industry from an early stage. According to the latter law, a therapeutic product for regenerative medicine is defined as a product distinct from pharmaceuticals and medical devices, enabling regenerative medical products to be given a conditional, time-limited marketing authorization much earlier than that under the previous system. The new legal framework of regenerative medicine is expected to achieve the aim to develop and promote regenerative medicine, aiming at timely provision of safe and effective therapies and products.