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

Please Log in to print the full article

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The draft guidance released by FDA in May entitled “Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products” is providing a useful foundation for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

[The story continues for subscribers beginning on p. 2. Nonsubscribers can get information on IPQ subscriptions/licensing and individual story purchasing by contacting Wayne Rhodes ([email protected]).]

Pages: 1 2

    ©2021 IPQ Publications