EMA Tackles How To Substantiate New Active Substance Claims For Biologics & ATMPs
The European Medicines Agency is seeking feedback on its position on assessing whether biological substances and advanced therapy medicinal products qualify for NAS status.
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EFPIA says the European Medicines Agency’s proposed criteria for determining “new active substance” status for biologicals may encourage subjective assessments and result in a higher standard for grant of the status.
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 EU, and updates on EU marketing authorization changes recommended by the CHMP.
Quviviq is to become the first dual orexin receptor antagonist available on the National Health Service. Just over 20,000 people in England could receive treatment with the drug in its first year, says the health technology assessment institute, NICE.