Will Change Ever Come Easy? Authorities Share Their Top ICH Q12 Challenges
Accelerating post-approval change oversight by focusing on ‘established conditions’ means trusting pharmaceutical quality management systems. But how?
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Draft recommendation offers path to ICH Q12 regulatory relief.
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.
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.