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IPQ Inside the global regulatory dialogue

ICH Q12 EWG Views Established Conditions as Pivotal in Evolving Lifecycle Regulation Internationally; EMA Workshop Provides Input

Dec 31st, 2015

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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The draft guidance released by FDA in May entitled “Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products” is providing a useful foundation for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.

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