Active Substances (NASs) approved by both the FDA and PMDA represented the largest number of new medicines approved this decade. Regulatory approvals by EMA were lower than the other agencies but were around the average for the agency considering the last 10 years. 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.

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