EU Regulatory Pathways for ATMPs: Standard, Accelerated and Adaptive Pathways to Marketing Authorisation.

Mol Ther Methods Clin Dev · 2019 · PMC6378853 · PMID 30815512

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highly significantno p-value reported

For complex ATMPs, e.g., gene-modified cells, the investment in CMC development 4 , 21 needed to demonstrate process robustness and product consistency is highly significant, and it should not be underestimated for hospital exemption use.

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