EMA's 2026–2028 GMP Work Plan: What Pharma Manufacturers Need to Know

In March 2026, the European Medicines Agency (EMA) published the new three-year work plan of the GMDP Inspectors Working Group (GMDP IWG), covering January 2026 to December 2028, alongside its 2025 annual report. It isn't legislation. But for anyone responsible for quality, compliance, or validation at a pharmaceutical or biopharmaceutical manufacturing site, it is one of the clearest signals available of where EU GMP expectations — and inspection focus — are headed over the next three years.

For manufacturers already stretched thin managing day-to-day compliance, work plans like this one are easy to file away as "something for next year." That would be a mistake. Several of the changes flagged in this plan touch the core of how facilities, equipment, computerised systems, and documentation are qualified and validated — which means the earlier a site starts preparing, the less disruptive the transition will be.

Here's a breakdown of what's in the plan, why it matters, and what pharma manufacturers should be doing now.

What Is the GMDP Inspectors Working Group Work Plan?

The GMDP IWG is the EU's central forum for coordinating and harmonising Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) activity across member states. Its three-year work plan sets out the regulatory priorities, guideline revisions, and inspection initiatives that European inspectors will develop, review, or finalise over the period it covers.

The 2026–2028 plan was developed in line with the European Medicines Agencies Network Strategy (EMANS) to 2028, with particular emphasis on strengthening oversight, protecting supply chain integrity, and expanding inspector capacity.

The headline takeaway: this cycle confirms substantial revisions to several foundational chapters and annexes of the EU GMP Guide, with a number of final texts targeted for delivery to the European Commission by the end of 2026.

The Core Changes on the Table

Chapter 1 — Pharmaceutical Quality System

Chapter 1 is due to be updated to integrate elements of the ICH Q9(R1) guideline on quality risk management, sharpening the emphasis on formalised, risk-based decision-making throughout the PQS.

Chapter 4 — Documentation

The documentation chapter is being revised to explicitly address digital, hybrid, and hosted systems. The shift in emphasis moves away from a records-based view of documentation and toward lifecycle-controlled governance — how data is created, controlled, and retained across its entire lifecycle, not just how it's filed.

Annex 11 — Computerised Systems

This is arguably the most consequential revision in the plan. The current Annex 11 dates back to 2011 — long before cloud computing, SaaS platforms, outsourced IT, and modern cyber threats were part of everyday pharmaceutical operations. The draft revision is a substantial rewrite, expanding from a short principle-and-clause structure into a much more detailed document covering system lifecycle management, supplier and service-provider oversight, data integrity, audit trails, electronic signatures, and system security.

For validation planning specifically, the revised Annex 11 draft points back to Annex 15 and quality risk management as the basis for determining scope and depth — reinforcing that computerised systems and equipment/facility validation are not separate conversations.

Annex 15 — Qualification and Validation

Annex 15 is under review as part of the same cycle, with the broader direction of travel pointing toward validation built on risk and lifecycle principles, rather than a one-time qualification event. This continues a trend that's been building for several validation cycles: qualification and validation as an ongoing, risk-managed activity rather than a checkbox exercise ahead of inspection.

Annex 22 — Artificial Intelligence (New)

For the first time, the EU GMP Guide will directly address artificial intelligence. The new Annex 22 is designed to complement — not replace — existing Annex 11 and Chapter 4 requirements, focusing on risks specific to AI-enabled systems: model evolution over time, explainability, and ongoing performance monitoring. Any manufacturer using or evaluating AI/ML tools in manufacturing, quality, or data analysis workflows should expect this annex to shape how those systems need to be governed and validated going forward.

Supply Chain Oversight and Inspection Methodology

Beyond the guideline revisions, the plan also points to:

Most deadlines across the plan are set for Q4 2028, though several key texts — including Chapter 1, Chapter 4, and Annex 11 — are targeted for finalisation considerably earlier, by the end of 2026.

Why This Matters Beyond Europe

It's tempting for manufacturers outside the EU to treat this as a regional update. That would be short-sighted. EU GMP expectations carry weight well beyond Europe's borders through mutual recognition agreements, third-country inspection programmes, and global manufacturing and supply networks. In practice, changes to EU GMP frequently shape how other regulators — including PIC/S member authorities — approach inspections, particularly around data integrity, computerised systems, and quality risk management.

If your site supplies into the EU, operates within it, or simply aligns its quality systems to EU GMP as a global benchmark, this work plan is worth treating as an early warning system rather than background reading.

What Manufacturers Should Be Doing Now

How Metron Engineering Can Help

Navigating a regulatory shift of this scale — spanning quality systems, documentation, computerised systems, and validation methodology all at once — is a significant undertaking for any manufacturer to manage alone. Metron Engineering supports pharmaceutical, biopharmaceutical, and medical device manufacturers with commissioning, qualification, and validation (CQV) services built around exactly this kind of lifecycle, risk-based approach — from DQ/IQ/OQ/PQ methodology through ongoing validation maintenance and computerised systems support.

As the EMA's 2026–2028 priorities move from draft guidance to final text, having a validation partner who understands both the current requirements and the direction of travel will make the transition considerably smoother.