Document Title Regenerative Medicine in Japan

1-Day Executive Briefing on Japan Regenerative Medicine in Japan January 26, 2016. Table of Contents Section Title Page # Japan 's Regenerative Medicine Regulatory Environment 4 Japan 's NHI Pricing 13 Japanese Regenerative Medicine Market 16 Appendix 22 Japan 's Regenerative Medicine Regulatory Environment Prior Regenerative Medicine Regulatory Landscape The Act on the Safety of Regenerative Medicine and a revision to the Pharmaceutical Affairs Act were promulgated by the Japanese government on Nov. 27, 2013 with the aim of providing a route to market that was more in sync with current industry/patient needs. Both laws came into force the following year on Nov. 25, 2014. Japanese Regenerative Medicine Landscape Prior to Nov. 25, 2014 Clinical Trials Medical Treatment at One's Clinical Research +. Own Expense*1 Marketed Drugs/Therapies Main Governing Rules/Regulations Main Governing Rules/Regulations Main Governing Rules/Regulations Medical Care Act Medical Care Act Pharmaceuticals Affairs Act Medical Practitioners' Act Medical Practitioners' Act Industry Guidelines High-Level Background Information High-Level Background Information The traditional route to market involving As treatment that falls under this category High-Level Background Information clinical t

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