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Access to Advanced Therapy Medicinal Products in the EU: Where Do We Stand?

Year: 2011

Type: article

Abstract: The European Union has a public health strategy and will generally ensure in all its policies and activities a "high level of human health protection". The new Regulation (EC) n 1394/2007 on advanced therapy medicinal products (ATMP), stems from this global policy and aims to harmonise access to the ATMP market. A real will for the harmonisation is clearly expressed in legal texts and enforced in the implementable procedures and requirements. However, several barriers remain. On the one hand, the scope of the ATMP Regulation is limited. On the other hand, Member States benefit from a wide margin of action.

Source: European Journal of Health Law

DOI: 10.1163/157180911x574146

Author: A. Mahalatchimy

Institutions: Université Toulouse III - Paul Sabatier, Inserm, Laboratoire Pacte, Université de Toulouse

Language: English

Topic: Biomedical Ethics and Regulation

Subfield: Physiology

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: green

OpenAlex ID: W2002192167

FWCI: 0.193

Cites:

Cited by: 4

Related to: 10