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Heide Muckenfuss, Klaus Cichutek, Egbert Flory

Current Regulation of Advanced Therapy Medicinal Products in the European Union

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).

Journal of International Biotechnology Law, Walter de Gruyter

Print ISSN: 1612-6068
Volume: 4, 01/2007
Pages: 16 - 19

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