EMA tries 'new approach' to aid gene therapy development
This article was originally published in SRA
Developers of gene therapies tend not to be familiar with the regulatory environment and so the European Medicines Agency is trying a new approach aimed at addressing their needs in a new draft guideline aimed at supporting and facilitating the development of such products1,2.
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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.
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