As part of the ongoing study to monitor regulatory performance, CIRS has analysed the trends in new medicines’ approval between 2004 and 2013 by six regulatory authorities including Health Canada, Swissmedic, Australian TGA, EMA, the US FDA and Japanese PMDA. The key findings for EMA, FDA and PMDA have already been discussed in detail in the CIRS R&D Briefing 54.
Review times continue to decrease in the majority of jurisdictions allowing an earlier licensing of important new medicines. Underlying factors influencing the overall time it takes for a new medicine to be submitted and then approved by an agency include company strategy, the conduct and the type of the review process, the type of the product and its therapeutic area; these aspects are analysed and discussed in this study.