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Median approval time for new active substances approved by EU, US and Japan by approval year.
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14th Annual Health Technology Assessment International (HTAi) Meeting; 17-21 June 2017, Rome, Italy
Drug Information Association (DIA) Annual Meeting;18-22 June 2017 Chicago, US
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R&D Briefing 62: New drug approvals in ICH countries 2007 – 2016
R&D Briefing 61: Building quality into decision-making processes in medicines’ development, regulatory review and health technology assessment
R&D Briefing 60: Early scientific advice from HTA agencies: How does the effective use of the various kinds of advice support a positive HTA recommendation?
Abstract: Liberti L, Breckenridge A, Hoekman J, Leufkens H, Lumpkin M, McAuslane N, Stolk P, Zhi K, Rägo L. Accelerating access to new medicines: Current status of facilitated regulatory pathways used by emerging regulatory authorities. J Public Health Policy. 2016 Mar 10. doi: 10.1057/jphp.2016.8. [Epub ahead of print]
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