Journal article
Gene therapy regulation: Could in-body editing fall through the net?
- Abstract:
- Somatic gene therapies may be authorised for marketing in the EU under the advanced therapy medicinal product regulation. These therapeutic compounds are sufficiently novel and complex in their potential effects to require specialist evaluation. However, the current definition of gene therapy medicinal products (‘GTMP’) risks excluding molecules which are not manufactured through techniques involving recombination. We consider the way, in which the ‘recombinant nucleic acid’ aspect of the GTMP definition is challenged by developments in gene-editing technology, and why a broader scope of GTMP regulation may be desirable.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
Actions
Access Document
- Files:
-
-
(Preview, Accepted manuscript, 242.6KB, Terms of use)
-
- Publisher copy:
- 10.1038/s41431-020-0607-y
Authors
- Publisher:
- Springer Nature
- Journal:
- European Journal of Human Genetics More from this journal
- Volume:
- 28
- Pages:
- 979-981
- Publication date:
- 2020-03-25
- Acceptance date:
- 2020-03-03
- DOI:
- EISSN:
-
1476-5438
- ISSN:
-
1018-4813
- Language:
-
English
- Keywords:
- Pubs id:
-
1091016
- Local pid:
-
pubs:1091016
- Deposit date:
-
2020-03-04
Terms of use
- Copyright holder:
- European Society of Human Genetics
- Copyright date:
- 2020
- Rights statement:
- © European Society of Human Genetics 2020
- Notes:
- This is the accepted manuscript version of the article. The final version is available online from Springer Nature at: https://doi.org/10.1038/s41431-020-0607-y
If you are the owner of this record, you can report an update to it here: Report update to this record