The EATCB has published a position paper on the regulatory classification of non-cultured, autologous keratinocytes and melanocytes.The Association feels these should be regulated under the Tissue and Cell legal framework, rather than as advanced therapy medicinal products (ATMPs).
The document was submitted for discussion by the President of the Association, Jacinto Sancho-Ibanez, and one of the authors, Jean-Paul Pirnay, at a meeting of the Competent Authorities held on 15th May 2019. The Competent Authorities were very impressed with the rationale applied and the methodological approach used to make the case, suggesting it could be used as an example for similar cases in the future. The Association would like to thank all the experts who collaborated to write this document:
- - Annika Hakamäki, PhD, Regea Cell and Tissue Center, Faculty of Medicine and Health Technology, Tampere University, Finland
- - Cornelia D. Richters, PhD, Stichting ETB-BISLIFE, Leiden, The Netherlands
- - Elisa Pianigiani, MD, Head of Siena Skin Bank, Le Scotte University Hospital, Siena, Italy.
- - Jean-Paul Pirnay, PhD, Queen Astrid Military Hospital, Brussels, Belgium.
- - Jürgen Ehlers, German Institute for Cell and Tissue Replacement DIZG, Berlin, Germany
- - Matthias Löwel, PhD, German Institute for Cell and Tissue Replacement DIZG, Berlin, Germany
- - Jacinto Sánchez Ibáñez, MD, A Coruña University Hospital, Spain
You can read the document here