Product Accepted Twice On PRIME Marks A First For EMA
Vertex and CRISPR can now get access to the advantages afforded by the European Medicines Agency’s priority medicines scheme for both of the indications they are targeting with their investigational gene therapy, CTX001.
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Lawyer and industry expert Alexander Natz sets out some important dos and don’ts for securing a successful launch of an advanced therapy in Germany.
Last year saw the number of applications accepted onto the European Medicines Agency’s priority medicines scheme inch up and the notoriously high rejection rate for applications drop.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.