Category
FDA, EMA, ECHA, ICH, USP and equivalent national-authority updates that change the rules for analytical procedures, process control, and chemical safety.
FDA finalized the Advanced Manufacturing Technologies designation program in January 2025. The older Emerging Technology Program handles earlier engagement; its guidance refresh is due by end-2026 under PDUFA VII.
USP chapters 858 (Raman Spectroscopy) and informational 1858 replaced chapter 1120 on 1 August 2020. Almost six years on, handheld identity testing is the workhorse application; compendial method adoption is uneven.
ICH Q14 reached Step 4 in November 2023. Thirty months on, the EU, FDA, Swissmedic and China NMPA have it on the books, but the ISPE readiness survey shows enhanced-approach adoption sitting at 19%.