RegQuality Review

RegQuality Reviewhttps://regqualityreview.com/2026-07-19T15:00:00.000ZEMA releases minor eAF 1.28 versions ahead of mandatory-use dateshttps://regqualityreview.com/news/ema-releases-eaf-128-minor-versions/2026-07-19T15:00:00.000Z2026-07-14T15:00:00.000ZRegQuality Review Research Desk

The July release carries bug fixes and sits inside a broader transition toward structured application data, new MAA forms, and mandatory PLM web-based eAF use for centrally authorised product variations.

FDA updates the working package for eCTD v4.0 submissionshttps://regqualityreview.com/news/fda-updates-ectd-v4-package-july-2026/2026-07-19T15:00:00.000Z2026-07-09T15:00:00.000ZRegQuality Review Research Desk

The July package refresh adds forward-compatibility samples and revises regional vocabulary, conformance, and transmission materials for a standard FDA already accepts for new applications.

EMA opens PMS product data through a public API betahttps://regqualityreview.com/news/ema-pms-api-and-data-roadmap-june-2026/2026-07-19T15:00:00.000Z2026-06-30T15:00:00.000ZRegQuality Review Research Desk

The June release expands access to structured medicinal-product data while marketing authorisation holders face staged manufacturer and pack-data enrichment deadlines.

Four EUDAMED modules become mandatory across the device markethttps://regqualityreview.com/news/eudamed-four-modules-mandatory-may-2026/2026-07-19T15:00:00.000Z2026-05-28T15:00:00.000ZRegQuality Review Research Desk

The transition moves actor, device, certificate, and market-surveillance records from voluntary use into required EU operating workflows, increasing the cost of disconnected regulatory data.

FDA finalizes a risk-based assurance approach for production and quality softwarehttps://regqualityreview.com/news/fda-finalizes-computer-software-assurance-2026/2026-07-19T15:00:00.000Z2026-02-03T15:00:00.000ZRegQuality Review Research Desk

The February guidance focuses assurance effort on software risk and confidence rather than prescribing one validation-document package, giving buyers a sharper way to examine vendor evidence and intended use.

FDA's QMSR changes the device inspection baselinehttps://regqualityreview.com/news/fda-qmsr-effective-february-2026/2026-07-19T15:00:00.000Z2026-02-02T15:00:00.000ZRegQuality Review Research Desk

The rule now incorporates ISO 13485:2016 by reference and replaces QSIT with a new inspection process, shifting the questions device manufacturers should ask of quality systems and evidence.

Revised EU variations guidelines enter applicationhttps://regqualityreview.com/news/eu-revised-variations-guidelines-apply-2026/2026-07-19T15:00:00.000Z2026-01-15T15:00:00.000ZRegQuality Review Research Desk

The January transition changes classification and procedure rules for post-authorisation changes, forcing regulatory operations teams to align systems, forms, content, and implementation dates.

EU consultation frames the next GMP controls for digital systems and AIhttps://regqualityreview.com/news/eu-gmp-digital-ai-consultation-closes-2025/2026-07-19T15:00:00.000Z2025-10-07T15:00:00.000ZRegQuality Review Research Desk

Draft revisions to Chapter 4 and Annex 11, plus a proposed Annex 22 for artificial intelligence, signal the direction of travel—but remain consultation drafts rather than operative requirements.