1. Comparison of median approval time of NASs by year of submission vs
Comparison of median approval time of NASs by year of submission vs. approval: * * *
Objective: Comparison of median approval times for NASs approved by the year of submission vs. approval:
Key Messages
Regulatory approval times are often a marker for the regulatory environment and can be viewed either by the year of approval, or the year of submission. Analysing review times by the year of submission enables tracking of compounds submitted within the same regulatory environment.
The median approval time for new active substances (NASs), approved by European Medicines Agency (EMA), United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), was calculated by year of submission and year of approval. Time was calculated from the date of submission to the agency, to the date of approval. The analysis by year of submission is based on products tracked to the end of Because the majority of products submitted in 2013 will be approved in subsequent years, 2013 was not included in this analysis as the figure would not be an accurate reflection of a median. Similarly, it is possible that this figure may change over time, particularly for products submitted in 2012, which may not have yet been approved.
Both year of submission and year of approval analysis show variation in approval times over the last 10 years. This is reflective of the different approval systems in the countries and can be indicative of the system or changes within the approval process during the time period; for example, for EMA, the two lines mirror each other reasonably well as the approval timelines are under a legal framework and there is only a small amount of variation seen (if any) between the year of submission and the year of approval. Both lines show a reduction in approval time following legislative changes adopted in 2005 (Directive 2004/27/EC), which lead to a reduction in the European Commission decision time from 3 months to approximately 2 months.
For PMDA, we can see a divergence of the two lines during a time range and this would suggest that although new compounds were being submitted post-2003, they were approved more rapidly. This is reflective of the new PMDA process and procedures post-2004 (prior to this time approvals were by the MHLW), but also indicates that there were a number of legacy products in the system which had been submitted prior to 2003 and as such increased the overall approval times when analysed by the year of approval.
For FDA, over , there has been a convergence of the submission and approval lines, indicating consistency of approval time.
EMA
FDA
PMDA
* Please note that approval times by year of submission may not be an accurate reflection of the cohort, particularly 2012, as some compounds submitted in 2012 may not have been approved by the end of 2013.