Core GMP Changes in Europe (Q4 2025)
Core GMP Changes in Europe (Q4 2025)
The European regulatory landscape has entered a phase of structural modernization. Three developments stand out.
1. EMA begins relying on FDA inspections
Since 1 October 2025, the EMA accepts FDA inspection outcomes for manufacturing sites outside the United States, reducing duplicate inspections and accelerating EU assessments.
2. Legally binding GMP for veterinary medicines and APIs
On 17 October 2025, the European Commission published two Implementing Regulations:
(EU) 2025/2091 — GMP for veterinary medicinal products
(EU) 2025/2154 — GMP for active substances in veterinary medicines
Both will apply from 16 July 2026, replacing previous guidance and giving the veterinary sector a dedicated, enforceable GMP framework.
https://eur-lex.europa.eu/eli/reg_impl/2025/2091/oj
https://eur-lex.europa.eu/eli/reg_impl/2025/2154/oj
3. Digital GMP: documentation, computerized systems, and AI
The EU launched a consultation to revise EudraLex Volume 4, including:
Updated Chapter 4 (Documentation)
Revised Annex 11 (Computerised Systems)
New Annex 22 (AI / Machine Learning)
The proposals introduce lifecycle data management, system validation, supplier control, and governance for AI models.
What Comes Next
In 2026–2027, three trends are likely to dominate:
Formal integration of digital compliance into EU-GMP.
The revision of Annex 11 and the introduction of Annex 22 will move GMP from “paper compliance” to continuous digital oversight, requiring validated systems, audit-ready records, and clear accountability for AI-driven decisions.
Expansion of sector-specific GMP.
The veterinary regulations are a precedent. Other domains (biologics, cell therapy, ATMPs) may gain similarly tailored GMP frameworks, clarifying responsibilities for manufacturers and supply-chain partners.
Greater transatlantic operational alignment.
EMA’s acceptance of FDA inspections signals a long-term shift. Instead of parallel audits, companies will face risk-based supervision coordinated at a regulatory level.
This will reward organizations with strong data governance, transparent quality systems, and consistent supplier control—while exposing those relying on minimal compliance.