June 2018 Slide of the month

  • A true comparison of regulatory performance can be derived from studying the review of compounds that were approved by all six agencies. This comparison was carried out for two approval year time cohorts in the last ten years, namely 2008-2012 and 2013-2017 to determine whether any trends could be identified.
  • Interestingly, the number of products approved by all six agencies in a two-year period increased from 12 new active substances (NASs) in 2008-2012 to 51 NASs in 2013-2017, which indicates that more products are becoming internationalised within the same time frame.
  • The overall length of time to registration, consisting of the submission gap and approval time may be a result of potential factors that impact registration of NASs. This may include company strategy to submit or target approval times at a particular agency, which is in turned influenced by the type of NASs as well as the use of expedited pathways within agencies to address unmet medical need for promising medicines.
  • The quickest time to registration was at US Food and Drug Administration (FDA) for both time frames, as a result of companies submitting there first as well as quick regulatory review times by the agency. Submissions to European Medicines Agency (EMA) occurred almost simultaneously with FDA, and the overall time to registration decreased, which may reflect the increased use of expedited pathways for important products by EMA. Following EMA and FDA submissions, the submission gap to Health Canada, Swissmedic and Australia’s Therapeutic Goods Administration (TGA) was approximately 80-100 days, which varied for the two time periods.
  • Although the longest submission gap occurred to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), the submission gap decreased by approximately one half and the approval time also decreased considerably, which may reflect the wider use of expedited review by the agency in 2013-2017 compared with 2008-2012. This demonstrates PMDA efforts to speed up the review of medicines, where the most notable changes made by the agency included an increase in resources, the introduction of prior-evaluation meetings to discuss clinical trial study results, as well as the prior-assessment consultations approximately 6 months before submission of a new drug application.

Definitions: New active substance (NAS): A chemical, biological, biotechnology or radiopharmaceutical substance that has not been previously available for therapeutic use in humans and is destined to be made available as a ‘prescription only medicine’, to be used for the cure, alleviation, treatment, prevention or in vivo diagnosis of diseases in humans. Approval time: Time calculated from the date of submission to the date of approval by the agency (calendar days). This time includes agency and company time. Submission gap: Date of submission at the first regulatory agency to the date of regulatory submission to the target agency (calendar days).

Bujar M, McAuslane N, Liberti L. 2018. R&D Briefing 67: New drug approvals in six major authorities 2007 – 2016: Focus on the availability of medicines and company size. Centre for Innovation in Regulatory Science. London, UK. For more trends and analysis, please download the full CIRS R&D Briefing 67