- Australia had the fastest median rollout time from regulatory submission to HTA recommendation in 2018 (373 days), followed by Canada (518 days). Lower timing variation was also seen in these two countries in 2018 compared with 2017, which indicated an improved consistency.
- The median rollout time was shortened in 2018 in most jurisdictions compared with 2017, while England showed an increased review time over the past four years.
- The biggest improvement in the rollout time was seen in Poland, with a decrease of 143 median days from 2017 to 2018. However, it still took the longest time for products to roll out in Poland compared with other jurisdictions.
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. Regulatory submission gap: Date of submission at the first regulatory agency to the date of regulatory submission to the target agency.
From: Wang T, Cai J, McAuslane N, Munro J. 2019. R&D Briefing 73: Review of HTA outcomes and timelines in Australia, Canada and Europe 2014 -2018. Centre for Innovation in Regulatory Science. London, UK.
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