On 4th March 2020, EMA published adoption of ICH Q12 guideline along with an implementation note which clearly states that the tools and concepts in the ICH Q12 guideline that are not foreseen in the EU legal framework will be considered when this framework will be reviewed. In the meantime, the European Commission, together with the EMA and the National Competent Authorities, will continue to work on the implementation of the ICH Q12 guideline within the existing EU legal framework.
Established Conditions and Product Lifecycle Management (PLCM) Document are not considered compatible with the existing EU legal framework on variations. EMA recommends that the legal framework always takes precedence over technical and scientific guidelines. Thus, definition of Established Conditions and their reporting categories must follow the requirements laid down in the current EU Variations Regulation and associated EU Variations Guidelines. With respect to the Product Lifecycle Management (PLCM) document, in case such a document is submitted, it cannot be currently recognized in the EU, due to the fact that it is not referred to in the EU legal framework.
- Kinapse considers this decision from the EMA potentially limits the overall anticipated benefits of ICH Q12 until the EU legal framework is updated.
After the adoption of ICH Q12 Guideline in November 2019, a Step 4 Introductory Training Presentation has been published on ICH website on 19th February. Expert Working Group recommends MAHs who wish to use tools described in ICH Q12 should consult regulatory authorities’ websites about the implementation of ICH Q12 in their region. Read more about this here.
It’s worth noting that USFDA and PMDA Japan are in process of implementing this guideline and have already started pilot programs for Established Conditions and PACMP, respectively.
Health Canada are not in a position to implement the tools at present and are considering a pilot program similar to that of the PMDA.
EMA published “Overview of comments received on draft guideline” in January last year and no further update has been announced since. Kinapse anticipates revision of EU Variations Regulation to fully implement the concepts of Q12 guideline.
The implementation of this transformational guideline for management of post approval changes in different regions will be an interesting journey.
Kinapse is keeping a close watch on this important topic. If you want to learn more and need help in understanding and acting on the guidance, please contact us.