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FDA And Industry Officials Tout Benefits Of Performance-Based Established Conditions In ICH Q12

 
• By Joanne S. Eglovitch

ICH given “two thumbs up" for performance-based established conditions concept in draft Q12 guideline. This approach gives industry much needed flexibility in managing post-approval changes as well as requesting fewer changes from regulators.ICH plans to adopt the guideline as a Step 4 document in 2019.  

Businessman sinking in heap of documents and asking for help

Pharmaceutical industry officials voiced their support for the inclusion of performance-based established conditions in the draft International Council on Harmonization’s Q12 guideline on post-approval changes. This approach gives manufacturers more flexibility in making lifecycle manufacturing changes to approved products without the need to obtain prior approval from regulators. 

FDA’s Ashley Boam discussed some of the key elements of the recently released ICH Q12 draft guideline Feb. 13 at...

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