Industry Urged To Use ICH Q12 Protocols To Ease Post-Approval Changes For Analytical Methods
Post-approval change management protocols could go a long way toward smoothing global rollout of analytical method changes, ICH Q12 expert says.
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The ICH is expected to release for public comment early next year its draft Q14 guideline establishing a lifecycle approach for analytical testing, as well as a Q2(R2) guideline to add some newer analytical methods.
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.
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.