Access to Advanced Therapy Medicinal Products in the EU: Where Do We Stand?
European journal of health law 2011 May; 18(3): 305-17
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.
Showing items related by title, author, creator and subject.
GMP facilities for manufacturing of advanced therapy medicinal products for clinical trials: an overview for clinical researchers. Alici, Evren; Blomberg, Pontus (2010-12)To be able to produce advanced therapy medicinal products, compliance with regulatory standards while maintaining flexibility is mandatory. For this purpose, careful planning is vital in the design or upgrade of a facility. ...
Access to Investigational Medicinal Products for Minors in Europe: Ethical and Regulatory Issues in Negotiating Children's Access to Investigational Medicines Pinxten, Wim; Nys, Herman; Dierickx, Kris (2010-12)Patients who search for a better treatment, an increased quality of life, or even a chance to preserve life itself may claim to have an interest in accessing investigational medicinal products (IMP), particularly when no ...