---
title: CRO Daily News — June 23, 2026
slug: daily-news-2026-06-23-cro
site: cro
post_kind: news
byline: BioBM
last_updated: 2026-06-24T00:00:02.496Z
---

### EMA Convenes AI-in-GMP Workshop to Shape Annex 22 Guidance on Adaptive Models
- EMA hosts two-day multistakeholder workshop (30 June–1 July 2026) to gather expert input on responsible AI use in medicines manufacturing, including guardrails for generative AI and large language models in GMP applications.
- Workshop addresses 2025 stakeholder feedback supporting potential use of adaptive and probabilistic models, reversing draft Annex 22 language that prohibited such technologies in critical GMP areas.
- EMA seeks expert consensus on validation paradigms, quality risk management frameworks, human oversight requirements, and guardrail effectiveness to enable risk-based AI deployment in high-impact manufacturing workflows.

**Operational Impact**

CRO and CDMO manufacturers must track Annex 22 finalization to understand whether adaptive AI and LLM deployment in GMP-critical processes will be permitted under new guardrail and validation standards, affecting manufacturing automation and compliance roadmaps.

*Source: [EMA What's New RSS](https://www.ema.europa.eu/en/events/good-manufacturing-practice-multistakeholder-workshop-expert-contributions-artificial-intelligence-guidance-development-annex-22)*

## References

1. [EMA What's New RSS — EMA Convenes AI-in-GMP Workshop to Shape Annex 22 Guidance on Adaptive Models](https://www.ema.europa.eu/en/events/good-manufacturing-practice-multistakeholder-workshop-expert-contributions-artificial-intelligence-guidance-development-annex-22)

Source: https://cro.directory/posts/daily-news-2026-06-23-cro