New drug approvals in ICH countries 2004-2013

http://cirsci.org/

From: Centre for Innovation in Regulatory Science (CIRS) – April, 2014

In 2013, the overall number of New Active Substances (NASs) approved by EMA, FDA and PMDA was comparable across the three agencies. This briefing looks specifically at trends in the number of approvals and approval times across the following agencies: European Centralised, US FDA and Japan PMDA.

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