EMA: Concept Paper on the revision of Annex 11 about computerized systems

EMA: Concept Paper on the revision of Annex 11 about computerized systems


On November 16, 2022, the EMA (European Medicines Agency) published a 5-page concept paper on the revision of Annex 11


The Annex 11 of the EU GMP Guideline is 11 years old. The EMA has now published a concept paper on how it intends to revise Annex 11 and allows comments until January 16th, 2023.

This places new compliance requirements on your regulated company! The concept paper explicitly mentions that the adaptation of existing systems to new requirements will be associated with costs.

Together with the PIC/S, the EMA proposes the following innovations and changes, among others:

  • The contents of the new Annex 11 are to replace the Q&A on Annex 11 and the Q&A on data integrity
  • Requirements regarding 'data in motion' and 'data at rest' are to be include
  • Modern concepts for 'digital transformation' should be taken into account
  • Criteria for the use of agile project methods will be defined
  • The EMA sees an urgent need to regulate machine learning and artificial intelligence in the context of GMP applications
  • Requirements for audit trails to become more comprehensive and detailed
  • Contents from the FDA Guidance on CSA are to be taken into account

Thescon will follow the further development for you and keep you informed.

The EMA concept paper can be found here (PDF link):

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/concept-paper-revision-annex-11-guidelines-good-manufacturing-practice-medicinal-products_en.pdf