EU market authorisation strategy: lessons from the first 22 ATMP submitted to the EMA

With 22 advanced therapy medicinal products (ATMP) having completed assessment by the European Medicines Agency, now seems a good point to reflect on what can be learned from these applications that led to 13 approvals. Analysis of these data reveals some evidence that the regulatory strategy employed has in some cases been sub-optimal, in particular the use of scientific advice. Overall ATMP are taking longer to approve, and raise more major objections than other medicines, and these two observations are likely linked. We observe the current approval rates for ATMP are below that of other medicines, with the exception of orphan designated ATMP. However, some of this may relate to the high proportion of submissions from small companies, which in common with all medicines submitted to the EMA have a lower chance of approval.

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