---
title: CRO Daily News — June 24, 2026
slug: daily-news-2026-06-24-cro
site: cro
post_kind: news
byline: BioBM
last_updated: 2026-06-24T23:59:59.871Z
---

### 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 generative AI and large language models in GMP applications.
- Workshop focuses on validation paradigms, guardrails, human oversight, and risk-mitigation strategies for adaptive and probabilistic models in high-risk GMP workflows where defect detectability is low but patient impact is high.
- EMA's 2025 stakeholder consultation showed industry support for enabling GenAI/LLMs in manufacturing, reversing the draft Annex 22 prohibition; final guidance will incorporate expert recommendations on control measures and quality risk management.

**Operational Impact**

CRO and CDMO manufacturers must track Annex 22 finalization to understand which AI technologies (adaptive models, GenAI, LLMs) will be permitted in GMP workflows and what validation, guardrail, and human-oversight requirements will apply to their manufacturing operations.

*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-2026-06-24-cro