FDA extends comment period on ICH Q12 guidance

The US Food and Drug Administration (FDA) has reopened the comment period on its draft guidance implementing the International Council for Harmonization’s (ICH) Q12 guideline on postapproval chemistry, manufacturing and controls (CMC) changes for new and marketed pharmaceuticals and drug substances.

The additional time was requested by the Pharmaceutical Research and Manufacturers of America (PhRMA).

FDA announced in a pre-publication notice in the 8 September Federal Register that “reopening the comment period for an additional 30 days from the date of publication of this notice will allow adequate time for interested persons to submit comments without significantly delaying agency decision-making on these important issues.” The original deadline was 19 July; 11 comments from individual pharmaceutical companies and trade associations had been received at that point

The draft guidance, published in May, helps manufacturers implement ICH Q12 by explaining how manufacturers can submit established conditions (ECs) for new drug applications (NDAs) and prior approval supplements (PASs), and reconciles ICH post-approval changes classification categories with FDA supplement categories. (RELATED: ICH Q12: FDA guidance explains US implementation, Regulatory Focus 21 May 2021).

In subsequent comments, however, industry complained that more clarity was needed on some of the core tenets of the guideline, such as ECs and postapproval change management protocols (PACMPS) to support a lower reporting category. (RELATED: Industry wants clarity on established conditions, PACMPs, reporting categories in comments on ICH Q12, Regulatory Focus, 9 August 2021).

Federal Register announcement

PhRMA’s request for extension

FDA extends comment period on ICH Q12 guidance

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