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Rejigging The Benefit-Risk Balance For Advanced Therapies In The EU

 
• By Neena Brizmohun

The European Medicines Agency’s Committee for Advanced Therapies has revealed its priorities for addressing the challenges manufacturers face in the fast-growing field of advanced therapies.

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The European Medicines Agency's advanced therapy committee has released its 2017 work plan

Updating the European guidance on genetically modified cells. Exploring how novel scientific and regulatory approaches might be used to make advanced therapy medicinal products (ATMPs) more readily available to patients. Reflecting on the current practice of defining the benefit-risk balance of ATMPs and whether too much emphasis is placed on risks and not enough on expected but realistic benefits.

These are some of the objectives in the 2017 work plan of the European Medicines Agency’s Committee for...

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