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Current Regulation of Advanced Therapy Medicinal Products in the European Union
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Published/Copyright:
February 8, 2007
Abstract
Background
The rapid biotechnological progress has promoted the development of novel medicinal therapies which are currently changing medical practice substantially. Patients may benefit from new opportunities for the treatment of various diseases, but on the other hand new risks have to be faced. To ensure timely access of patients to innovative medicines while taking safety aspects into consideration, an appropriate legislation is needed. This review aims at giving an overview of the role of the so called “Advanced Therapy Products” in today's medical practice and describes their current regulation in the European Union (EU).
Published Online: 2007-02-08
Published in Print: 2007-01-26
© Walter de Gruyter
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Articles in the same Issue
- Editorial
- Four Key Roles for Regulation of Biotechnology: Are They Being Fulfilled at the International Level?
- Regulating Assisted Reproduction in the EU: Time for a new Directive?
- Current Regulation of Advanced Therapy Medicinal Products in the European Union
- The UNCTAD BioTrade Initiative and the CBD
- Legal Limitations on Genetic Research and the Commercialisation of its Results in the Republic of Croatia
- From ethical advice to legal regulation: History and practise of Research Ethics Committees in Germany
