FDA Readies ICH Q12 Implementation Guidance, Learns Lessons From Pilot

06 Mar 2020

• By Joanne S. Eglovitch

Upcoming ICH Q12 implementation guidance will translate terminology on post-approval changes into a US context, said a US FDA official who also shared some lessons learned on established conditions.

Manufacturing Flow chart — US FDA About To Release ICH Q12 Implementation Guideline • Source: Shutterstock

The US Food and Drug Administration will soon be issuing guidance implementing the International Council on Harmonization’s Q12 guideline in the US that will, among other things, translate ICH post-approval change classification categories to FDA supplement categories, and address how to file established conditions, or ECs.

The FDA’s Mahesh Ramanadham provided an update on the agency’s implementation of ICH Q12 in the US on 25 February...