EMA’s Revised ATMP Evaluation Procedure Gets Industry Thumbs Up
EU pharmaceutical companies believe the revisions the European Medicines Agency has made to its procedure for evaluating gene and cell therapy products addresses the specific needs of advanced therapy developers. They have also welcomed, in principle, a revised EMA guideline on the follow-up and risk management of such products.
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An action plan produced by the European Medicines Agency and the European Commission has put forward a number of ideas for streamlining the processes for developing and assessing advanced therapy medicines, with the aim of speeding up the current sluggish rate of ATMP approvals. Industry says it will assess the proposals to see how well they address the key issues worrying the sector.
The European Medicines Agency is developing a strategy to ensure that women have sufficient information to make informed choices about taking medicines during pregnancy and breastfeeding.
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