Regulators ‘more efficient at approving drugs’
pharmafile | January 19, 2015 | News story | Research and Development, Sales and Marketing | EMA, EMA), FDA, Health Canada, PMDA)., Pharmaceutical and Medical Devices Agency, Swissmedic, TGA, approvals, cirs, reuters
Global regulatory bodies have become faster at approving new drug products more quickly and consistently, according to a new analysis published by the UK-based Centre for Innovation in Regulatory Science (CIRS).
The research found that six of the leading drugs regulators worldwide had improved the efficiency of their times top new drug approval over the past decade.
The report, by the research arm of industry intelligence analysts Thomson Reuters, looked at trends in new medicine approvals between 2004 and 2013 by six regulatory authorities in Canada (Health Canada), Switzerland (Swissmedic), Australia (Therapeutic Goods Administration , TGA), Europe (EMA), the US (FDA) and Japan (Pharmaceutical and Medical Devices Agency, PMDA).
Drug approval times varied greatly in 2004, when the difference in the median approval time between the fastest and the slowest agency was 500 days.
Since then however, the data shows there has been a noticeable convergence between the median approval times for all six regulators. The gap between the fastest and the slowest approvals shrank by 300 days during the following decade, and the median approval timings for new medicines converged to much similar approval times across the six agencies.
In 2013, the median approval times (in the order of highest to lowest) were 511, 478, 391, 350, 342 and 304 for Switzerland, Europe, Australia, Canada, Japan and the US respectively.
“The decrease in review times in the majority of jurisdictions has allowed for an earlier licensing of important new medicines”, says Magda Bujar, a research analyst at the Centre for Innovation in Regulatory Science.
The EMA had half of approvals granted after about 15 months, whereas Swissmedic took approximately 18 months to grant approval to 50% of submitted NASs during that period. These figures changed only slightly over the decade, emphasising the consistency of these agencies’ processes it found.
In 2011-2013, 20% of FDA approvals were granted within six months of submission which was faster than the other authorities and which the report says “may show the role played by priority review in the US system”.
However, the CIRS data also indicates that expedited approval applications such as FDA’s accelerated approval pathway, do not appear to have caused the drop in approval times across all regions. The three regulators with the slowest average approval times used expedited approval pathways the least.
Overall new medicine approvals – often seen as a measure of the health of the pharmaceutical industry – rose in the second part of the decade, 2009-2013, compared with 2004-2008. By 2013, the number of new medicines approved by each jurisdiction was 37 for Canada, 29 for both Europe and the US, 28 for Japan, 25 for Australia and 23 for Switzerland.
The rise was at least partly accounted for by anti-cancer therapies. There was an 8% increase in the approval of anti-cancer and immunomodulator medicines across the six agencies compared with 2004-2008 – which Bujar speculated could be a sign that companies operating in this area may be ‘creating better submission dossiers’.
But approvals of anti-infective medicines decreased by 8% over the same period, “emphasising the increasing difficulties that pharma companies face during the development and approval of new anti-microbial agents”.
Lilian Anekwe
Related Content
Rethinking oncology trial endpoints with generalised pairwise comparisons
For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …
Alto Neuroscience’s schizophrenia treatment granted FDA Fast Track designation
Alto Neuroscience has announced that its investigational treatment for cognitive impairment associated with schizophrenia (CIAS) …
FDA approves Moderna’s updated COVID-19 vaccines targeting new variant
The US Food and Drug Administration (FDA) has approved Moderna’s updated COVID-19 vaccines, Spikevax and …
