ICH Q12 guideline draws more comments from industry

Regulatory NewsRegulatory News | 27 October 2021 |  By 

A major pharmaceutical industry group is calling for the US Food and Drug Administration (FDA) to institute several revisions to the International Council for Harmonization’s (ICH) Q12 guideline on postapproval changes.
The document was released by FDA for public feedback in May. (RELATED: ICH Q12: FDA guidance explains US implementation, Regulatory Focus, 21 May 2021).
The International Society for Pharmaceutical Engineering (ISPE) suggested in its 8 October comments that proposed reporting categories should be placed in the regional section and not module 3 of the Common Technical Document (CTD), where quality information is placed. The group asserted that putting the reporting category in module 3 would lead to “regulatory divergence” since not all regulators plan to incorporate ICH Q12 in their regulatory frameworks.
FDA’s guidance implementing ICH Q12 specifies that “when proposing specific ECs [established conditions], applicants should include a scientific justification for their selection in the relevant parts of module 3 of the application. In this justification, applicants should address both the identification of particular parameters or attributes as ECs and the proposed reporting categories (if applicable).”
ISPE states that “reporting categories should not be required to be provided in Module 3.2.S or 3.2.P documents, since this will bring a degree of regional divergence to these documents and place an additional burden on the applicants.”
Instead, discussion of final regional reporting categories should be placed in the Product Lifecycle Management (PLCM) document under the regional section of the CTD. Supporting information from Module 3 can be cross-referenced as appropriate, according to the ISPE proposal.

ISPE further recommends that FDA align post-approval change categories with those set in the ICH Q12 guideline, echoing another comment submitted this summer. (RELATED: Industry wants clarity on established conditions, PACMPs, reporting categories in comments on ICH Q12, Regulatory Focus, 9 August 2021).
FDA should “revise the relevant CFR [Code of Federal Regulations] chapters and FDA post-approval change guidelines to align with the classification framework in the current document.”
The ICH Q12 guidance outlines two categories for post approval changes. One is for prior approval and the other is for notifications. The US has three categories: prior approval, which calls for a postapproval supplement; moderate changes, which calls for a changes being effected in 30 days (CBE) supplement; and low notification, which includes low-risk changes submitted in an annual report.
Eliminate annual reports
ISPE also wants FDA to eliminate a section of the guidance calling for applicants to submit annual reports for all analytical procedures that have been modified during the reporting period without a regulatory submission.
The group says “there should be no requirement to submit them in an annual report (unless the changes impact ECs). The expectation to submit analytical procedures in Annual Reports essentially makes all analytical procedure parameters ECs, which is not the intended outcome of ICH Q12.”
Overall, however, the group supports the guideline. “The document clarifies the overall framework for categorizations of post-approval changes to align ICH Q12 and FDA terminology, discusses the implementation of Established Conditions (ECs) including lifecycle and filing considerations, PACMPs and PLCM [product lifecycle management] documents, as well as key considerations for PQS [Pharmaceutical Quality System] and Change Management,” wrote ISPE in its letter to FDA.
The ICH Q12 guideline was adopted in November 2020 to facilitate the management of postapproval chemistry, manufacturing and controls (CMC) changes for new and marketed pharmaceuticals and drug substances.
ISPE comments on ICH Q12


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