REGULATORY
Legal Changes on Horizon for GMP Inspection Authorities, Other Regulation Panel Topics?
The Ministry of Health, Labor and Welfare (MHLW) appears to be looking at potential legal amendments to address issues related to pharmaceutical regulations, including the review of authorities to conduct GMP inspections and post-approval procedures for manufacturing changes. On February…
To read the full story
Related Article
- MHLW Panel to Draw Up Report by Year-End towards Amendment of PMD Act
February 13, 2024
- MHLW to Kick Off Debates on PMD Act Amendment on Feb. 9
February 5, 2024
- MHLW Plans Joint Surprise Onsite Inspections by PMDA and Prefectural Govts
November 16, 2023
- MHLW Regulatory Panel OKs New Procedures for Post-Approval Manufacturing Changes
October 16, 2023
REGULATORY
- Pharma Renews Call to Scrap “Spillover,” “Huge-Seller” Rules as FY2026 Talks Enter Final Stretch
December 11, 2025
- 2024 Reform Spurred New Development Activity, 20 Projects Entered Clinic: Industry Poll
December 11, 2025
- Regenerative Medicine Group Accepts Deferred Debate on Market Expansion Re-Pricing
December 11, 2025
- Wholesalers Urge Price Hikes on Sub-20-Yen Drugs as Negative Margins Mount
December 11, 2025
- Two Bayer/AskBio Gene Therapies Bag Sakigake Designation
December 11, 2025
Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…





