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 The revision aims to address outdated requirements,…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
- Japan to Revise Guidance on Standards for Biological Raw Materials
November 25, 2025
COMMENTARY
- G1 Rule to Hit Originator Biologics for First Time, Impact Seen for Up to 13 Brands
February 25, 2026
- Hisamitsu’s MBO: Is Shareholder Accountability Trust-Building or a Shackle?
February 18, 2026
- Is Calling for an Abolition the Right Play? Rethinking Japan’s FY2027 Off-Year Drug Price Revision
February 9, 2026
- Japan’s Biological Raw Material Rules Enter Major Revision; Clarity on Benefits and Safety Holds Key
February 5, 2026
- TSE’s Growth Market Reform Puts Pressure on Biotechs
January 27, 2026
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…





