Kinapse welcomes you to ICH Q12

The USFDA has recently released a presentation and recording of “ICH Q12: Overview and application to Generic drugs” as a part of a 2 day virtual webinar session organised by CDER SBIA Generic drug forum. Here in, FDA has clarified that final guidance on ICH Q12 will be published in the next few months. The Agency confirmed that PACMP’s (comparability protocols) can be submitted at any time as per existing draft guidance dated April 16th 2020 however FDA plans to update this draft guidance to make it more consistent as per current ICH Q12 guidance requirements.

FDA also intends to publish a draft implementation guidance with more details on using ICH Q12 in the US. ICH Q12 training materials are also in development for worldwide use.

Follow the link for the full update:

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