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8 articles tagged regulation.
The first half of 2026 delivered mixed vendor earnings, an unusually dense regulatory calendar, and modest conference energy on the process-analytics floor. Here is what moved the needle.
At its Rio de Janeiro Assembly on 2-3 June 2026, ICH brought E6(R3) Annex 2 to Step 4, extending GCP to decentralised and registry-based trials. Q1 and Q3E remain in draft review.
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.
QbD is the broader regulatory philosophy that PAT serves. A primer on the ICH and FDA documents that built it, the vocabulary it introduced, and how process analytics fits inside it.
Twenty years after the first FDA continuous manufacturing approval, the technology is no longer experimental - but adoption is uneven, and the bottlenecks are now organizational, not technical.
Twenty years of guidance documents - 2004 FDA PAT guidance, ICH Q8 through Q14, ASTM E2363 - turned a fragmented vocabulary into a working framework. A reading guide.
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.