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EU Pharma Revision Of Hospital Exemptions For ATMPs 'Is Unsatisfactory'

 
• By Francesca Bruce

The EU legislative overhaul falls short on dealing with the issue of hospital exemptions for advanced therapies, says the Alliance For Regenerative Medicine.

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EU Proposals On Hospital Exemptions for ATMPs lack clarity • Source: Shutterstock

The European Commission’s proposed reforms to the EU pharmaceutical legislation aim to improve and standardize the application of hospital exemptions for advanced therapy medicinal products (ATMPs). However, the draft provisions lack clarity and do little to “fix the issues” and prevent the over-use of the mechanism, according to the Alliance For Regenerative Medicine (ARM), which represents small and large companies, academic research institutions, major medical centers and patient groups.

“We cannot say we are satisfied,” Paolo Morgese, ARM’s head of public affairs Europe, told the Pink Sheet in an...

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