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REGULATORY
- JIHS Now Up and Running as Japan Version of CDC
April 3, 2025
- PMD Act Amendment to Enter Diet Debate; Parallel Deliberations Planned for Bill to Scrap Off-Year Revisions
April 3, 2025
- Japan Picks 14 “Loss” Products as Drugs with Highest Priority for Development
April 2, 2025
- GSK’s Shingrix Buttresses Label with Long-Term Data
April 2, 2025
- MHLW Says It Will Handle Info Disclosure Requests as per Rules
April 2, 2025
- MHLW Doles Out Orphan Tags to 12 Compounds
April 1, 2025
- J&J’s Opsumit Designated as Drug for Specific Use: MHLW
April 1, 2025
- Japan Jittery over Mass Layoffs at FDA, though HHS Says Reviewers Won’t Be Affected
March 31, 2025
- Label Updated for Eliquis, Imbruvica, and Brimonidine: PMDA
March 31, 2025
- MHLW Flags Risk of Eye Disorders Associated with Tivdak upon Approval
March 31, 2025
- Daisuke Koga Named Head of PMDA’s International Office
March 31, 2025
- AMED Ties Up with Korea’s Govt Backed Research Institute
March 31, 2025
- Sakigake Tag Withdrawn for Boehringer, AbbVie APIs
March 31, 2025
- Nitrosamine Detected in Sumitomo’s Arotinolol, but No Recall Planned
March 28, 2025
- Choseido’s Kawauchi Plant Suspended for 1 Month on GMP Violation
March 28, 2025
- Japan Approves J&J’s Lazcluze, Genmab’s Tivdak, and More
March 28, 2025
- Japan Won’t Ban Red No. 3 for Now but Asks Industry for Self-Inspections
March 27, 2025
- It’s Time to Review Conditional Approval System for Regenerative Medicines: MHLW Official
March 27, 2025
- PMDA Stepping Up Efforts to Woo Overseas Startups to Japan
March 27, 2025
- MHLW Presents Expected Roles of Clinical Research Hospitals towards Criteria Review
March 26, 2025
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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…
