Use this url to cite publication: https://cris.mruni.eu/cris/handle/007/37569
Classification and ethical issues regarding advanced therapy medicinal products
Type of publication
Straipsnis kitoje duomenų bazėje / Article in other database (S4)
Author(s)
| Author | Affiliation |
|---|---|
Title
Classification and ethical issues regarding advanced therapy medicinal products
Publisher (trusted)
Institute of Medical Ethics and Bioethics |
Date Issued
| Date |
|---|
2013 |
Extent
p. 2-7
Is part of
Medicínska etika & bioetika = Medical ethics & bioethics. Bratislava : Institute of Medical Ethics and Bioethics, 2013, vol. 20, no. 3-4.
Abstract (en)
European Union’s (EU) Regulation No. 1394/2007 has introduced a new regulatory category of medicines – advanced therapy medicinal products, into the EU legal system. They are divided at present into three major groups: gene therapy, somatic cell therapy and tissue engineered medicinal products. The reasons for such classification are complex and vary in a broad spectrum comprised from political-legislative to scientific concerns. The aim of the paper is to discuss some classification issues that arise from the reluctance of the European legislator to address in a clearer way some important ethical issues with regard to those advanced therapies.
Is Referenced by
Type of document
type::text::journal::journal article::research article
ISSN (of the container)
1335-0560
eLABa
3281794
Coverage Spatial
Slovakija / Slovakia (SK)
Language
Anglų / English (en)
Bibliographic Details
54