Cell and gene therapies (CGT) are the new frontier of medicine, offering life extension and sometimes cures for previously untreatable conditions. These revolutionary therapies are expensive and follow non-traditional routes to approval. There are different approaches to the requirements and how they are established including an additional reimbursement approval step required in the European Economic Area (EEA). When comparing requirements to obtain approval for cell and gene therapies between the FDA and the European Medicines Agency (EMA), you may be struck by large variations in terminology. However, a closer look quickly indicates that sponsors face similar challenges in both markets.

Read on to learn more about the differences and similarities between FDA and EMA in their approaches to CGT.

The FDA has approved 27 CGTs to date: 14 cell therapies and 13 gene therapies. The EMA has approved 24 CGTs to date: 16 gene therapy medicinal products (GTMP), 4 somatic cell therapy medicinal products (SCTMP) and 4 tissue-engineered therapies (TET). 13 products received approval in both regions. Products receiving approval in both regions include CAR-T cell therapies that have proven effective at treating blood cancers (e.g., Kymriah, Yescarta, Tecartus and others).1

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References

  1. How Do Cell & Gene Therapy Requirements Differ Between FDA & EMA? (n.d.). https://www.bioprocessonline.com/doc/how-do-cell-gene-therapy-requirements-differ-between-fda-ema-0001

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