EMA PROLONGS PARALLEL REGULATOR/HEALTH BODY ADVICE SYSTEM FOR PHARMACOS
April 1st, 2016
A PILOT project helping pharmacos integrate their feedback from market approval regulators with advice from health bodies who may pay for their medicines will become permanent, the European Medicines Agency (EMA) has said. In a detailed assessment, EMA has concluded that a trial parallel regulatory-health technology assessment scientific advice system, using a best practice guide, “should continue as an operational platform.” The initiative “allows developers of new medicines to receive simultaneous feedback on their development plans from both regulators ...
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