Note on EU implementation of ICH Q12 (guideline on technical and regulatory considerations for pharmaceutical product lifecycle management)

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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. Given that the level of flexibility in different ICH regions tends to vary depending on the respective legal frameworks, the ICH Q12 guideline explicitly states that its adequate implementation will depend on the applicable regulatory framework in place. Several of the tools and concepts foreseen in the ICH Q12 guideline are considered compatible with the EU legal framework on variations and some even stem directly from this framework. These tools and concepts can already be applied, as such, by industry by following the current EU variations framework. In other words, no particular actions are required in the EU in order to implement these parts

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