The ICH Q12 guideline on technical and regulatory considerations for pharmaceutical product lifecycle management was adopted by the CHMP (European Committee for Medicinal Products for Human Use) in January 2020. On March 4, the EMA (European Medicines Agency) published a two page note on the implementation of ICH Q12. It addresses the fact that there are conceptual differences between ICH Q12 and the EU legal framework. Therefore, a 1:1 application in the EU is not possible without further ado.
This applies to
- the term “Established Conditions (ECs)” and the associated reporting categories (section 3.2.3), which do not exist in EU law, and
- the Product Lifecycle Management (PLCM) document, as described in Chapter 5 which is not considered compatible with the existing EU legal framework on variations.
However, it is clearly understood, that the legal requirements of the EU take precedence over scientific or technical guidelines. Therefore, the definition ECs and their reporting categories must comply with EU Variation Regulation(EC) No1234/2008 and the associated guidelines. As far as PLCM documents are concerned, if submitted, they currently cannot be recognised in the EU.
Irrespective of this, the concepts in ICH Q12, which are not foreseen in the EU regulatory framework will be further reviewed. The European Commission, together with the EMA and the National Competent Authorities, will continue to work on the implementation of ICH Q12 within the existing EU legal framework.
EMA: Note on EU Implementation of ICH Q12