European Union:
EMA Publishes Report On Regulation Of Advanced Therapy Medicines
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On June 3, 2016, EMA published its report from a multi-stakeholder meeting held
to explore possible ways to foster the development of Advanced
Therapy Medicinal Products ("ATMPs") in Europe and expand
patients' access to these new treatments. ATMPs comprise gene
therapies, tissue engineered products, and somatic cell therapies.
According to EMA, such medicines have the potential to reshape the
treatment of a wide range of conditions, particularly in disease
areas where conventional approaches are inadequate. However, eight
years since EU legislation on ATMPs entered into force in 2008,
only five ATMPs are currently authorized. The report details
concrete proposals to encourage development and authorization of
ATMPs in the EU.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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