Why ‘Established Conditions’ CMC Approach Could Generate More Supporting Information, Not Less
The ‘established conditions’ concept enshrined in the ICH Q12 draft guideline was the US FDA’s answer to the background information that has cluttered new drug applications in the quality-by-design era. But early indications are that it will amass information clutter of its own.
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The focus would be on high-impact changes to high-impact models under approach advocated by BioPhorum, IQ Consortium and PPAR.
Anticipating the eventual adoption of ICH Q12, the US FDA is training staff on some of its key principles. An agency official says ICH Q12 necessitates a new way of thinking about and reviewing regulatory submissions for post-approval changes and such training is necessary to ensure review consistency.
A final revision of the ICH Q12 lifecycle management guideline is expected to overcome a conflict with EU variations legislation and offer more clarity on what is, and what is not, an established condition subject to post-approval change reporting requirements.