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Industry wants clarity on established conditions, PACMPs, reporting categories in comments on ICH Q12

Posted 09 August 2021 | By Joanne S. Eglovitch 

Industry wants clarity on established conditions, PACMPs, reporting categories in comments on ICH Q12

Members of the pharmaceutical industry want the US Food and Drug Administration (FDA) to align reporting categories with the International Council for Harmonization (ICH) Q12 guideline on postapproval changes while others seek clarity on how manufacturers can use postapproval change management protocols (PACMPs) to support a lower reporting category. Others wanted clarity on established conditions (ECs) as well as non-ECs, a core tenet of the guideline.
These industry comments were issued in response to FDA’s guidance on how ICH Q12 is to be implemented in the US; the deadline for submitting comment was 19 July. The agency received 11 responses from trade associations and individual companies (RELATED: ICH Q12: FDA guidance explains US implementation, Regulatory Focus, 21 May 2021).
The ICH Q12 guideline, adopted in November 2020, aims to facilitate the management of postapproval chemistry, manufacturing and control (CMC) changes for new and marketed pharmaceuticals and drug substances. The ICH guidance is now being implemented by regulators; FDA made the ICH guidance available on 11 May.
Clarity on established conditions
In its comments, the Biotechnology Innovation Organization (BIO) says clarity is needed on whether the document replaces FDA’s guidance on established conditions published in 2015.
“It is not clear whether this document should be read in conjunction” with FDA’s May 2015 draft guidance on established conditions, or whether that guidance has been withdrawn, noted BIO. “Should companies continue to use the 2015 guidance to define what FDA ‘typically considers to be ECs’?” (RELATED: Which Drug Manufacturing Changes Should be Reported? FDA Explains, Regulatory Focus, 1 June 2015)
BIO also wants clarity on non-ECs. “We note that FDA have introduced terms ‘specific ECs’ which closely mirrors the term ‘explicit ECs’ proposed in the Step 1 drafts of ICH Q12. We support this but note the need to refer to the 2015 guidance to determine what are ‘non-specified ECs.’”
Alignment on postapproval change categories
To avoid confusion, the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ Consortium) calls on FDA to align its postapproval change categories with those set in the ICH Q12 guideline.
The ICH Q12 guidance outlines two categories for postapproval changes: prior approval and 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-30) supplement; and low notification, which includes low-risk changes submitted in an annual report.
“The existing US regulatory change system fits conceptually already well to the ICH Q12 change categories,” the IQ Consortium writes. “According to the draft guidance it seems to be the intention to maintain CBE-30 and CBE-0 as terms. However, a harmonization of the wording towards the ICH Q12 definition in all ICH regions is preferred to facilitate life cycle management for globally marketed products. A harmonized approach is a primary objective of ICH Q12.”
More clarity on PACMPs
In yet another area, the Association for Accessible Medicines (AAM) said more clarity is needed on how postapproval change management protocols (PACMPs) can be used to support a lower category of reporting a change.
“The guidance, which is expected to provide clarity related to ICH Q12-Parent, does not address the type of prior knowledge needed to support a lower category of reporting a change. For instance, it is not clear if prior knowledge based on information gathered from other regions of the world would suffice to justify lowering the reporting category of a change or if it should be interpreted that the information gathered needs to only come from FDA approved products,” according to AAM’s comments.
PACMPs are agreements between applicants and regulators on a prospective change to be implemented; they outline the studies and acceptance criteria to support the change. These agreements can be submitted with the original application or with a postapproval supplement. ICH Q12 specifies that manufacturers that submit a PACMP can be accorded the flexibility to implement change in a lower reporting category than those that do not use the PACMP.
Comments on FDA’s ICH Q12 guidance  


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Tags: FDA, ICH, Q12

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