【Client Alert】The Basic Regulatory Framework for Regenerative Medicine in Japan
The Basic Regulatory Framework for Regenerative Medicine in Japan
This page provides an English executive summary of the Japanese article “再生医療に関する技術規制の基本構造”. The full article is available in Japanese.
Executive Summary/ Key Questions
- What are the primary laws regulating regenerative medicine in Japan?
ー Regenerative medicine is governed by two main frameworks: the Act on the Safety of Regenerative Medicine (ASRM) and the Pharmaceuticals and Medical Devices (PMD) Act. The ASRM focuses on "medical provision" by healthcare institutions, while the PMD Act regulates the "manufacturing and sale of products" by businesses. -
How does the ASRM classify regenerative medicine technologies?
ーTechnologies are categorized into three risk levels:
・ Class I (High Risk): Technologies involving iPS or ES cells.
・ Class II (Medium Risk): Technologies using somatic stem cells, such as adipose-derived stem cells.
・ Class III (Low Risk): Technologies using processed somatic cells.
Each class requires specific review processes by certified committees and submission of plans to the Ministry of Health, Labour and Welfare (MHLW). -
What is the "Conditional and Time-Limited Approval" system?
ー This is a unique system under the PMD Act that allows for early, time-limited approval of regenerative medicine products once their efficacy is "presumed" and safety is confirmed. In March 2026, iPS-derived products "Amshepri" and "Re-Heart" were approved under this framework. -
What standards are required for manufacturing regenerative medicine products?
ー Manufacturers must comply with GCTP (Good Gene, Cellular, and Tissue-based Products Manufacturing Practice) standards. This ensures rigorous quality and manufacturing control, similar to GMP for pharmaceuticals.
This English page is provided for informational purposes only. The Japanese version constitutes the authoritative text.
（Written by: Takuya Mima）
Takuya Mima, Attorney at Law
takuya.mima@tkilaw.com
Practice Areas: Life Sciences & Healthcare, Intellectual Property, M&A, Cross-border Transactions
Takuya Mima has more than a decade of experience at leading Japanese law firms, advising on a broad range of corporate matters, including mergers and acquisitions, strategic alliances, business reorganizations, and cross-border transactions.
He focuses particularly on the life sciences and healthcare sectors, where he regularly advises on intellectual property–related transactions such as licensing agreements, joint research and development arrangements, and brand and design protection. He also has substantial experience in intellectual property disputes, including patent litigation in the United States.
Takuya has further strengthened his practical insight through secondments to the legal department of a multinational pharmaceutical company and to the intellectual property division of a major manufacturing company. These experiences enable him to provide practical, business-oriented advice that bridges legal, regulatory, and intellectual property considerations.
He has also authored numerous publications on intellectual property and healthcare law.