The ICH Q12 Expert Working Group (EWG) is viewing “established conditions” as a linchpin concept in its effort to define and drive a more improvement friendly, simplified, and harmonized regulatory approach to product lifecycle management internationally.
However, the EWG members also recognize the challenges on the table in defining the concept in a way that achieves the desired objectives.
At issue are the interrelationships between established conditions (ECs) and the other lifecycle management regulatory components across the development/submission/control strategy/post-approval change/quality system/inspection continuum.
The draft guidance released by FDA in May entitled “Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products” is providing a useful foundation for the EWG discussions on the role that established conditions should play in evolving the lifecycle management regulatory paradigm.
[CLICK HERE for the complete story. Nonsubscribers can get information on IPQ subscriptions/licensing and individual story purchasing by contacting Jonathan Trethowan (Jonathan@ipq.org).]
