Regulatory watch: European regulatory experience with advanced therapy medicinal products

Nat Rev Drug Discov. 2019 Jan;18(1):8-9. doi: 10.1038/nrd.2018.200. Epub 2018 Nov 30.

Authors

Lisbeth Barkholt¹, Caroline Voltz-Girolt², June Raine³, Tomas Salmonson¹, Martina Schüssler-Lenz⁴

Affiliations

¹ Medicinal Products Agency, Uppsala, Sweden.
² European Medicines Agency, London, UK.
³ Medicines and Healthcare Products Regulatory Agency, London, UK.
⁴ Paul-Ehrlich-Institut, Langen, Germany.

PMID: 30498203
DOI: 10.1038/nrd.2018.200

No abstract available

MeSH terms

Biological Products / therapeutic use*
Cell- and Tissue-Based Therapy*
Drug Approval / legislation & jurisprudence*
Drug Discovery / legislation & jurisprudence*
Europe
Genetic Therapy / legislation & jurisprudence*
Government Regulation*
Humans

Substances

Biological Products