Revised ICH viral safety guideline: NGS is in, animal use (mostly) out

The EMA and FDA are implementing revisions to an important quality guideline, addressing viral safety for products derived from human or animal cell lines (ICH Q5A R(2)). The revisions provide important updates to the 1999 version, acknowledging a field that’s grown and changed significantly in the interval. The final version includes some extensive updates to a 2022 draft revision, to include reduced use of animals in testing and development of these products.

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