In 2011, the number of New Active Substances (NASs) approved in all the ICH countries increased compared to 2010, and FDA represented the largest number of new medicines approved this decade. Regulatory approvals are often a measure of the pharmaceutical industries output and are, along with approval time, used as a marker of the regulatory environment.

This briefing looks specifically at trends in the number of approvals and approval times across the European Centralised process, the US FDA process and the Japan PMDA process.