EU Industry Wants ‘More Fluid’ Accelerated Assessment Procedure At EMA
EFPIA says that the European Medicines Agency’s fast-track regulatory review mechanism can be perceived by sponsors as being “hard to get and easy to lose.”
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FDA Commissioner Robert Califf spoke of the need for a better hand-off to CMS, including tailoring trials to generate evidence relevant for Medicare coverage. He also weighed in on the possibility of accelerated approval for chronic disease drugs, among other topics.
The European Medicines Agency will hold submission readiness meetings with the sponsors of products in the priority medicines scheme around a year ahead of them submitting their marketing authorization applications for regulatory review.
Applications from drug companies should also include a commercial proposal, says Pharmac.