The last decade, 2006-2015, has seen a continuation of the convergence and general decrease in the approval times amongst six major regulatory authorities, namely the European Medicines Agency (EMA), the US Food and Drug Authority (FDA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada, Swissmedic and the Australian Therapeutic Goods Administration (TGA).
Convergence in approval times has resulted in compounds being internationalised in a shorter time frame in the recent years. The second half of the decade, 2011-2015, also saw a major increase in the number of approvals of anti-cancer and immunomodulator new active substances (NASs), compared with 2006-2010, and these now constitute approximately a third of all NAS approvals across the six agencies.
The six agencies have continued to put initiatives in place to improve the quality and timeliness of review, which may explain their general decrease and tightening in approval times. One area agencies have been concentrating on is improvement of the company submissions ahead of the agency assessment in order to ensure that target timelines are met. Such activities further improve consistency and predictability of the review, but have also impacted the overall approval time either in a positive or negative matter as seen in the last decade.