REGULATORY

• Diet Begins Deliberations on Amendment of PMD Act, Bill to Repeal Off-Year Scheme
  April 7, 2025

• Shingles Shots Added to NIP, HPV Catch-Up Program Extended: MHLW
  April 7, 2025

• LDP’s New Fiscal Reform HQ to Release Draft Report by Late May
  April 4, 2025

• 3-Party Talks Fail to Reach Specifics on OTC-Like Drugs
  April 4, 2025

• Japan Mulls Amendment of GCP Ordinance, Making Single IRBs a Rule
  April 3, 2025

• 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• Sakigake Tag Withdrawn for Boehringer, AbbVie APIs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

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