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- Title
EU directive on clinical trials penalizes small sponsors.
- Authors
Meldolesi, Anna
- Abstract
Smaller EU biotechnology companies and public funders of clinical research are concerned that an EU directive passed in 2001 and designed to harmonize provisions governing clinical research across Europe doesn't take their needs into account because it was modeled on certain clinical trial practices of the pharmaceutical industry. The directive (2001/20), which must be transposed into national law by May 2004, standardizes procedures for gaining approval to begin and manage a clinical trial. It also lays down standards for the manufacture of drugs and provides for their quality assurance.
- Subjects
BIOTECHNOLOGY industries; CLINICAL trials; CLINICAL medicine research; DRUG development; EUROPEAN Union
- Publication
Nature Biotechnology, 2003, Vol 21, Issue 8, p838
- ISSN
1087-0156
- Publication type
Article
- DOI
10.1038/nbt0803-838