In 2013, the overall number of New Active Substances (NASs) approved by EMA, FDA and PMDA was comparable across the three agencies. Nevertheless, despite this similarity, the number of NASs approved by both the FDA and PMDA did not match 2012‟s high, with a 25% and 20% decrease in the number of NASs approved in the US and Japan respectively compared to 2012. As well as that, although the number of NASs approved by EMA increased by 43% compared to 2012, a number of these compounds had already been approved in the USA in previous years and partly signifies an instance of “catching up” by EMA.
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. Approvals are often a measure of the pharmaceutical industry’s output and are, along with approval time, used as a marker of the regulatory environment.