New EMA GMP Guidelines in the next three Years

The European Medicines Agency (EMA) has published a new version of the '3-year work plan for the Inspectors Working Group' covering the period from January 2026 to December 2028. The plan is drawn up by the GMDP Inspectors Working Group (GMDP IWG). It also includes, in some cases, revised timelines for the revision of GMP requirements.

The following chapters and annexes are to be finalised by the end of 2026 ("provide the European Commission with a final text"):

• Chapter 1 (Pharmaceutical Quality System)
• Chapter 4 (Documentation)
• Annex 15 Qualification and Validation
• Annex 22 Artificial Intelligence

At least a review is to be carried out for the "Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products". The procedure for implementing the ICH Q12 guideline "Lifecycle Management" is also to be clarified by the end of the year.

A great deal of work is then planned for the next two years, and the revisions to the following chapters and annexes are to be finalised by the end of 2028:

• Chapter 3 (Premises and Equipment)
• Chapter 5 (Production)
• Chapter 7 (Outsourced Activities)
• Chapter 9 (Self-Inspection)
• Annex 3 Manufacture of Radiopharmaceuticals
• Annex 6 Manufacture of Medicinal Gases
• Annex 14 Manufacture of Medicinal Products Derived from Human Blood or Plasma

Further details can be found in the current document The 3-year work plan for the Inspectors Working Group.