This explanatory note is published in parallel to the ICH Q12 Step 5 guideline
(EMA/CHMP/ICH/804273/2017) and annexes (EMA/CHMP/ICH/831751/2017) which were adopted by CHMP in January 2020.
The ICH Q12 guideline provides regulatory tools and enablers with associated guiding principles, which are intended to harmonise globally the management of quality related post-approval changes. Some of its principles have been inspired by the current EU legal framework on variations.
The ICH Q12 guideline puts forward a risk-based approach that includes a certain amount of flexibility in making post-approval changes as regards the quality of the product. The EU legal framework on variations also provides for a risk-based approach, and any flexibility it provides follows directly from the specific provisions that are set out in this framework. As a result, there are some conceptual differences between ICH Q12 and the EU legal framework which have an impact on how the full operational and regulatory flexibility as laid down in the ICH Q12 guideline can be implemented in the EU…