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European Medicines Agency – Explanatory Note on Implementation of ICH Q12 Guideline


European Medicines Agency (EMA) explained considerations for implementing the International Council of Harmonisation’s (ICH) Q12 guideline on technical and regulatory considerations for pharmaceutical product lifecycle management. This guideline was adopted by EMA’s Committee for Medicinal Products for Human Use (CHMP) in January 2020.

This guideline provides regulatory tools and enablers with related guiding principles, which are meant to harmonise globally the management of quality associated post-approval changes and has some related differences between ICH Q12 and the EU legal framework which have an effect on how the full operational and regulatory flexibility as laid down in the ICH Q12 guideline can be implemented in the EU.

Industry can adopt some of the tools and concepts foreseen in the ICH Q12 guideline by following the current EU variations framework. The ICH Q12 guideline refers to this required information as ‘Established Conditions’ and their reporting categories must follow the requirements laid down in the current EU variations regulation and related guidelines.

With respect to the Product Lifecycle Management (PLCM) document, in case such a document is submitted, it cannot be presently recognised in the EU due to the fact that it is not now referred to in the EU legal framework. With regard to Chapter 6 “Pharmaceutical quality system (PQS) and change management” and Chapter 7 “Relationship between regulatory assessment and inspection”, while the expectations on industry and regulators are generally in line with current practice in EU, some additional clarifications concerning demonstration and evaluation of PQS effectiveness and communication between regulators will require similar consideration during the implementation of the guideline.

Other tools and concepts in the ICH Q12 guiding principle that are not in the EU legal framework will be considered when this framework will be reviewed.