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 Plans To Propose Q14 Guideline On Analytical Testing In January
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 Sees Snags In Implementing ICH Guide On Post-Approval Changes
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.
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.