The BioPhorum response to the Annex XV Report on the proposal for universal PFAS restrictions. It is considered by the BioPhorum collaboration that unless ECHA provide the biopharmaceutical manufacturing industry with appropriate exemptions or derogations to find, test and validate alternatives and execute a transition out of these materials (where alternatives are available), there will be a real threat to the global availability of critical vaccines and biotherapeutics.
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BioPhorum feedback on ICH Q5A (R2)
Mar 2023 | Cell & Gene Therapy, Deliverable, Deliverables Report, Development Group, Drug Substance, Feedback to agency, POI - Development Group, Regulatory, Regulatory Governance, Supply Partner
BioPhorum’s in-depth feedback includes 70 line-by-line, detailed comments, including the rationale for the points and any proposed changes/recommendations that are deemed necessary by the team to ensure a harmonized implementation across industry and regulatory agencies.
Response document for the British Pharmacopoeia public consultation for characterisation of the particle population in AAV products best practice guidance
Jan 2023 | Cell & Gene Therapy, Deliverable, Deliverables Report, Feedback to agency, High Level Analytics
BioPhorum response to British Pharmacopoeia ATMP working party draft Part 1 guidance; ‘Characterisation of the Particle Population in AAV Products’.
BioPhorum feedback on Columbia decree
Jan 2023 | Deliverable, Deliverables Report, Drug Substance, Feedback to agency, Post Approval Strategies
Colombia decree consolidated feedback from the BioPhorum Post Approval Change Management workstream, Colombia sub-team. This content is only available to BioPhorum members.
Feedback on revised chapter 5.14 leading to EDQM Pharmeuropa monograph 34.3 gene therapy products for human use, chapter 5.34 and chapter 5.2.12Â
Sep 2022 | Cell & Gene Therapy, Deliverable, Deliverables Report, Feedback to agency, Regulatory Strategy
BioPhorum CGT Regulatory Strategy workstream response to revised chapter 5.14 leading to EDQM Pharmeuropa monograph 34.3 gene therapy products for human use, chapter 5.34 and chapter 5.2.12. This content is available to BioPhorum members only.
BioPhorum feedback on ICH Q14 and Q2(R2)
Sep 2022 | Cell & Gene Therapy, Deliverable, Deliverables Report, Feedback to agency, POI - Regulatory, Regulatory, Regulatory Governance
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.
Feedback on the WHO draft approach towards development of a global regulatory framework for CGT
Sep 2022 | Cell & Gene Therapy, Deliverable, Deliverables Report, Feedback to agency, Regulatory Strategy
A cross sub-team team of 18 members from 14 companies submitted feedback on WHO Approach towards the development of a global regulatory framework for cell and gene therapy products (document WHO/BS/2022.2424)
Feedback on FDA draft guidance on considerations for the development of CAR-T cell productsÂ
Jun 2022 | Cell & Gene Therapy, Deliverable, Deliverables Report, Feedback to agency, Regulatory Strategy
BioPhorum CGT Regulatory Strategy workstream members provide feedback on the FDA draft guidance on considerations for the development of CAR-T cell products .
Feedback on FDA draft guidance on human gene therapy products incorporating human genome editingÂ
Jun 2022 | Cell & Gene Therapy, Deliverable, Deliverables Report, Feedback to agency, Regulatory Strategy
BioPhorum CGT Regulatory Strategy workstream provided feedback on FDA draft guidance on human gene therapy products incorporating human genome editing .
BioPhorum response to USP <1083> draft monograph: Supplier qualification and guidance for associated risk assessments
Apr 2022 | Deliverable, Deliverables Report, Feedback to agency, Forecast and Demand Planning, Supply Partner
BioPhorum member only content. This is detailed consultation response from BioPhorum Supply Partner to USP on draft monograph <1083>.