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BioPhorum feedback on ICH Q14 and Q2(R2)

BioPhorum feedback on ICH Q14 and Q2(R2)

Sep 2022 | , , ,

This paper is the BioPhorum response to the recent ICH Q14 and Q2(R2) consultation. Overall, the first-draft guidelines seen by the team need to be less detailed in the main body of the documents but more specific to analytical methods. The documents must also be consistent throughout (across Q14 and Q2 and between the main body texts and examples). Further, detailed examples are needed for modalities other than small molecules (e.g., biologics, cell and gene therapies, etc.) as the small molecule examples are not relevant in some key respects. In the view of the BioPhorum team, the current documents will not drive a consistent understanding of regulatory expectations and the provision of information by industry to regulators.

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Industry feedback on ICH harmonized guideline: Continuous manufacturing of drug substances and drug products Q13 draft version

Industry feedback on ICH harmonized guideline: Continuous manufacturing of drug substances and drug products Q13 draft version

Feb 2022 | , , , ,

A comprehensive response to ICH Continuous manufacturing of drug substances and drug products Q13 draft version. The BioPhorum team overall think the draft reads well and believes the concepts and ideas are aligned with BioPhorum thinking on continuous manufacturing for biologic drug substance and drug product.

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Industry feedback on USP bioreactivity draft monographs

Industry feedback on USP bioreactivity draft monographs

Jan 2022 | , , ,

This BioPhorum paper contains feedback on the USP bioreactivity monographs to plastics used for manufacturing, and the use of resources. It also comments on the potential in vitro tests that should be included, the removal of the implantation test and safety, the removal of Class I to VI, and the topics for omission or inclusion into the <1031> chapter outline. The expert feedback provided in these documents aims to support the USP and, ultimately, produce documents that improve patient safety – but with adequate use of finite analytical resources, which would not be the case with divergent expectations.

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Feedback on the FDA draft guidance for industry studying multiple versions of a cellular or gene therapy product in an early phase clinical trial

Jan 2022 | , , , ,

This member document summarizes consolidated feedback and recommendations from a collaboration of BioPhorum members on the FDA draft guidance for industry studying multiple versions of a cellular or gene therapy product in an early phase clinical trial consultation.

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BioPhorum response to USP draft monograph: Supplier qualification and guidance for associated risk assessments

Feedback to MHRA / British Pharmacopoeia: Guidance on the application of vector copy number for the cell and gene therapy community​

Oct 2021 | , , ,

A BioPhorum member only summary document detailing consolidated feedback and suggested recommendations from the High-Level Analytics team on MHRA / British Pharmacopoeia: Guidance on the application of vector copy number for the cell and gene therapy community​.

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Industry feedback on ICH Q12: implementation considerations for FDA-regulated products

Industry feedback on ICH Q12: implementation considerations for FDA-regulated products

Oct 2021 | , , , ,

The aim of ICH Q12 is clearly stated as a framework to facilitate the management of post-approval CMC changes. This document in the industry response to an agency consultation on draft guidance on ICH Q12. The biopharmaceutical industry through these comments commends the agency on leading the way to the implementation of ICH Q12. The BioPhorum comments are heavily influenced by the principle of simplification, which is why our views sometimes differ from the draft guideline.

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