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European regulatory experience with advanced therapy medicinal products

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Figure 1: Experience in the evaluation of advanced therapy medicinal products in Europe.

Acknowledgements

We thank R. Hemmings, S. Ruiz, H.-G. Eichler, P. Celis, S. Vamvakas and J. Llinares for their contributions to the review of the article.

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Author notes

  1. Lisbeth Barkholt and Caroline Voltz-Girolt: These authors contributed equally: Lisbeth Barkholt, Caroline Voltz-Girolt

Authors and Affiliations

  1. Medicinal Products Agency, Uppsala, Sweden

    Lisbeth Barkholt

  2. European Medicines Agency, London, UK

    Caroline Voltz-Girolt

  3. Medicines and Healthcare Products Regulatory Agency, London, UK

    June Raine

  4. Medicinal Products Agency, Uppsala, Sweden

    Tomas Salmonson

  5. Paul-Ehrlich-Institut, Langen, Germany

    Martina Schüssler-Lenz

Authors
  1. Lisbeth Barkholt
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  2. Caroline Voltz-Girolt
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  3. June Raine
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  4. Tomas Salmonson
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  5. Martina Schüssler-Lenz
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Corresponding author

Correspondence to Caroline Voltz-Girolt.

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Competing interests

The authors declare no competing financial interests.

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Supplementary information

Supplementary information S1 (box)

Analysis of scientific advice and major objections for ATMPs (PDF 543 kb)

Supplementary information S2 (box)

EMA support to ATMP developers (PDF 137 kb)

Supplementary information S1 (table)

Status of the 20 marketing authorisation applications as of June 2018 (PDF 101 kb)

Supplementary information S2 (table)

Analysis of the major objections raised during the evaluation of the marketing authorisation applications (cut-off June 2018) (PDF 183 kb)

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Barkholt, L., Voltz-Girolt, C., Raine, J. et al. European regulatory experience with advanced therapy medicinal products. Nat Rev Drug Discov 18, 8–9 (2019). https://doi.org/10.1038/nrd.2018.200

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  • DOI: https://doi.org/10.1038/nrd.2018.200

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