The European Medicines Agency and the European Network for Health Technology Assessment have launched a joint advisory platform to facilitate the launch of medical treatments.
The joint EMA-EUnetHTA platform will enable companies seeking marketing authorisations for treatments to request parallel rather than separate consultations on evidence provision. The benefits will include a more structured and effective interaction between the EMA and HTA bodies, and a more streamlined process for drug developers, the EMA said today.
The launch of medical treatments in the EU follows a two-step process. A single national regulator decides whether to authorise a treatment after weighing up its benefits and risks, and then national HTA bodies assess the value of the treatment versus other available options and issue recommendations to consumers and policymakers.
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