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 interview
Key Takeaways
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The European Commission’s proposed Directive aims to improve the application of hospital exemptions for Advanced Therapy Medicinal Products.
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It stipulates that ATMPs manufactured under a hospital exemption must comply with standards equivalent to those set out in existing regulations.
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Implementing acts will specify further detail, including requirements for hospital exemption approval applications.
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Member states must communicate information on approvals and withdrawals to the EMA
