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.