REGULATORY
Japan’s 1st Orphan Regenerative Medicine Status Given to Skin-Derived Cell Sheet
The Ministry of Health, Labor and Welfare has designated JACE, a cultured epidermal autograft of Japan Tissue Engineering, as Japan’s first orphan regenerative medicine product.JACE is expected to be used in patients with congenital giant pigmented nevus, with the product,…
To read the full story
Related Article
- Cultured Epidermal Autograft JACE Recommended for Orphan Designation
October 27, 2014
REGULATORY
- MHLW Issues Q&A on Conditional Approval System
May 1, 2026
- Panel Backs Proposal to Allow Antibody Drugs Like Beyfortus in NIP
May 1, 2026
- METI Clarifies Naphtha Comments, Reaffirms Medical Priority
April 30, 2026
- Japan Minister Rules Out Full Self-Pay for OTC-Like Drugs
April 30, 2026
- Govt’s Bio-WG Wraps Up Biopharma Investment Roadmap Draft
April 30, 2026
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…





