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document summarizes consolidated feedback and recommendations from a collaboration of BioPhorum members on the FDA draft guidance for industry studying multiple versions of a cellular or gene therapy product in an early phase clinical trial consultation.
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Summary BioPhorum member only document detailing feedback and suggested recommendations on EMA draft toolbox guidance for PRIME marketing authorisation applications.
Regulators require the biopharmaceutical industry to manage changes to raw materials in a compliant way – including those initiated by suppliers. A significant challenge is how to manage the large volume of supplier change notifications (SCNs) while ensuring a compliant and uninterrupted supply of materials for production. Companies often need to manage hundreds of raw material SCNs per year, potentially covering hundreds of materials from a...
This guidance document identifies the relevant change areas, and for each area, exemplifies the type of changes which the biopharmaceutical industry needs to be informed about. It also lists the required information, in terms of supporting data and documentation, to support notification of changes. This guidance is relevant to all raw materials used to produce biopharmaceutical products, including but not limited to cell culture media, fermentation broth components, column resin, buffers, solvents, and excipients. By highlighting the changes biopharmaceutical industry end-users need to know about and specifying the information required, the intention of this industry-aligned guidance is to reduce the quantity of rework required and the time taken to process change requests. In turn, this will reduce variability in demand patterns as end-users refrain from building extensive inventories to mitigate against the perceived risks which arise from proposed changes. While complete alignment and standardization on the information which should be provided for changes is not possible, a more robust alignment on the typical information required, as set on in this guidance, will significantly improve the current state.