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5 articles tagged ema.
Each update to an approved chemometric procedure in the EU is a regulatory event. Commission Regulation No 1234/2008 and ICH Q14 determine which variation type applies and whether prior approval is needed.
Three years after ICH Q13 came into force, 17 continuous-manufacturing drug approvals sit on the FDA's ledger and 72 CM technologies have joined the Emerging Technology Program - but adoption remains narrow.
EMA's Q&A on nitrosamines now runs across a main document and three appendices, with Appendix 1 refreshed on 24 June 2026. The methodology stack pushes analytical work firmly into LC-MS/MS at sub-ppb sensitivity.
FDA, EMA, and PMDA all build on ICH Q2(R2) and Q14, but their expectations for routine chemometric model upkeep, post-approval changes, and reference-method failures diverge in ways that shape submission strategy.
EMA's March 2026 Q&A on 3D-printed solid oral doses accepts inline NIR and Raman spectroscopy for unit-level rejection, anchoring personalised micro-batches in the QbD and RTRT framework.