COMMENTARY
Japan’s Biological Raw Material Rules Enter Major Revision; Clarity on Benefits and Safety Holds Key
Japan is poised to make the most sweeping revision in eight years to the Standards for Biological Raw Materials — a regulation affecting a wide range of products, from pharmaceuticals to regenerative medicines. The revision aims to address outdated requirements,…
To read the full story
Related Article
COMMENTARY
- 20 Years at a Glance: Overseas Sales Surge at Japan Pharma, but R&D Investments Lag
June 9, 2026
- Are Technical Discussions Enough for Japan’s CEA System?
May 25, 2026
- Shift Underway in Pharma Workforce as Sales Roles Shrink, Manufacturing Rises
April 28, 2026
- Gene Therapies Expand into AMD, Raising Promise and Cost Concerns
April 24, 2026
- Challenges in a Post-AG Era: Ensuring a Reliable Supply System
April 6, 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…





