May 2017 Slide of the Month


For each NAS (new active substance) approved between 2007 and 2016 by the European Medicines Agency (EMA) centralised procedure, the United States Food and Drug Administration (FDA) and Japan Pharmaceuticals and Medical Devices Agency (PMDA), the date of submission and the date of approval by the agency were collected from the public domain (the agency website). These dates were used to calculate the median approval time for each year of approval, by regulatory authority.

Key messages

  • FDA and PMDA NAS median approval times converged in 2007-2016, with PMDA the fastest of the three agencies for a third year in a row.
  • Although Japan historically had the longest regulatory approval times, this has decreased following the creation of PMDA and with its increase in resource and commitment, PMDA review timing is now equivalent to FDA.
  • In 2016, the FDA overall median approval times decreased slightly from 2015 by 14 days. Nevertheless, when comparing 2007-2011 with 2012-2016, the median FDA approval times increased by 29 days, which is likely due to the process changes introduced under the Prescription Drug User Fee Act (PDUFA) V legislation.
  • Europe, within the confines of its legislative approval procedures and processes, has had the slowest approval times out of the three countries since 2011. Nevertheless, EMA approval times have been consistently lower for the last three years, by approximately 70 days compared with 2012-2013.

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.

From: From: Bujar M, McAuslane N, Liberti L. 2016. R&D Briefing 62: New drug approvals in ICH countries 2007 – 2016.

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