EU pushes advanced therapies

This month, the EU Committee for Advanced Therapies (CAT) will be holding its first workshop to discuss the implementation of a new legislation designed to harmonize gene therapies, cell therapies and tissue-engineered products within Europe. The lack of EU-wide regulatory frameworks for such novel therapies has, in the past, hampered the biotech industry's growth and hindered patient access. The recently passed EU Advanced Therapies Regulation lays down rules on the authorization, supervision and pharmacovigilance of newly emerging therapies. The committee, which is responsible for preparing draft opinions on quality, safety and efficacy of advanced therapies for final approval by the Committee for Medicinal Products for Human Use (CHMP), is part of the European Medicines Agency (EMEA). It includes representatives from CHMP, member states, clinicians and patient organizations. The regulation outlines a centralized marketing authorization procedure and special incentives for small and medium-sized enterprises (SMEs). Christiane Abouzeid, of the BioIndustry Association, believes that the CAT will help small companies by providing expert advice on complex products. An industry spokesperson notes that incentives for companies and investors within the new Advanced Therapies Regulation will more than offset any short term “pain” while procedures are set up.

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Aldridge, S. EU pushes advanced therapies. Nat Biotechnol 27, 110 (2009). https://doi.org/10.1038/nbt0209-110b

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