There have been major improvements in the regulatory environment in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) countries over the last decade, which led to a decrease in the time to approval as well as an increase in the number of medicines that become available. Furthermore, the introduction and wider use of special regulatory pathways and designations have played a major role in this process, particularly for medicines developed in response to unmet medical need.

As part of an ongoing study to monitor regulatory performance, CIRS has analysed the trends in new medicines’ approval between 2007-2016 for three regulatory authorities; the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), the European Medicines Agency (EMA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). For the purposes of this Briefing, facilitated regulatory pathways (FRP) include:

  • Expedited review to accelerate regulatory assessment: in this report refers to EMA Accelerated Assessment, FDA Priority Review, PMDA Priority Review
  • Other pathways to enable the availability, review and/or approval of medicines; in this report include EMA Conditional Approval (CA), EMA Exceptional Circumstances (EC), FDA Fast Track (FT), FDA Breakthrough Therapy Designation (BTD), FDA Accelerated Approval (AA)