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Cancer World Newsletter - Cutting Edge. Approval rating: how do the EMA and FDA compare? PDF Print E-mail
Europe’s EMA takes on average more than half a year longer to grant marketing approval to new cancer therapies, and the two regulators sometime differ over the patient groups and setting for which the licence is given. In this Cutting Edge article we ask what lies behind these disparities and look ahead at the regulatory challenges posed by new generations of cancer therapies.

What do you think?

  • Is the lengthy approval time in Europe inevitable given the EU’s federal structure, or are approvals being held up by unnecessary bureaucracy?
  • How well do judgements made by regulators reflect the priorities of the patients and the public that they serve?
  • Is there a need for greater transparency on the reasoning and value judgements behind regulatory decisions, or is the EMA a model of openness compared with many other bodies that take important decisions affecting our healthcare.
 You can read the article here. Press the comment button at the end and share your views.