FDA Readies ICH Q12 Implementation Guidance, Learns Lessons From Pilot
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.
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Post-approval change management protocols could go a long way toward smoothing global rollout of analytical method changes, ICH Q12 expert says.
EU authorities say the new tools and concepts needed for implementing the new international guideline on post-approval changes (ICH Q12) will be considered when the EU framework is reviewed.
An international guideline on managing post approval changes to drugs, which was initially criticized because of its incompatibility with legal frameworks in certain ICH regions such as the EU, has been finalized.