ARTICLE
22 July 2016

EMA Publishes Report On Regulation Of Advanced Therapy Medicines

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The report details concrete proposals to encourage development and authorization of ATMPs in the EU.
European Union Food, Drugs, Healthcare, Life Sciences

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.

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