Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
166 Applications Received for Preliminary Interviews for Regulatory Strategy Consultation in First 9 Months: PMDA
The Pharmaceuticals and Medical Devices Agency (PMDA) received a total of 166 applications for preliminary interviews for regulatory strategy consultation, a new service it introduced on July 1, 2011, as of March 31 this year. Seventy-seven or over 40% of…
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REGULATORY
- Update: DMD Gene Therapy Elevidys Cleared for NHI Listing at 305 Million Yen
February 13, 2026
- MHLW Orders Label Revisions for Vyxeos, Inlyta, Imbruvica, and More Drugs
February 13, 2026
- MHLW Orders Label Revisions for Sulfite-Containing Medical Products
February 13, 2026
- PMDA Urges Proper Use of Colchicine, Advises against High-Dose Administration
February 12, 2026
- PMDA to Offer Priority Consultations for Overseas Startups
February 12, 2026
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