FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

EMA Spells Out Plans to Encourage Advanced Therapy Drug Products

Nov. 16, 2018
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The European Medicines Agency issued an updated action plan to encourage advanced therapy medicinal products (ATMPs) — including the release by year’s end of draft guidelines for clinical trial sponsors.

The EMA said the proposed actions are designed to increase the opportunity for patients to be treated with novel therapies in clinical trials and via authorization of new products.

 “The EU is committed to support the development of these products and will keep monitoring developments in the field to ensure that the regulatory framework supports — and not hinders — the development of ATMPs,” the agency said.

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