INTERNATIONALISATION – FOCUS ON EMA AND FDA In 2012-2014, there were 118 NASs approved either by EMA or FDA or both 7 NASs approved only by EMA 81 NASs approved by EMA and FDA 30 NASs approved only by FDA These were internationalised in PMDA, Health Canada, Swissmedic and TGA as follows (approval status tracked until the end of 2016) 81 approved by EMA and FDA 50 approved X 31 not approved 67 approved X 14 not approved 68 approved X 13 not approved 65 approved X 16 not approved Methodology New active substances (NASs) approved initially in 2012-2014 by either the European Medicines Agency (EMA) centralised procedure (N=7) or the United States Food and Drug Administration (FDA) (N=30) or both (N=81) were identified. The approval status was tracked for those NASs in Japan Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada, Swissmedic and the Australian Therapeutic Goods Administration (TGA) until the end of 2016. Key messages Not all NASs approved in 2012-2014 by EMA, FDA or both received approval in the other 4 regulatory agencies (PMDA, Health Canada, Swissmedic and TGA) by the end of 2016. There were more products only approved in FDA (30) as opposed to only EMA (7), but the biggest group of NASs were approved by both EMA and FDA (81). For the 81 NASs approved by both EMA and FDA, 84% were approved by Swissmedic, followed by Health Canada (83%), TGA (80%) and PMDA (62%). For the 30 NASs only approved by FDA, 27% were approved by Health Canada, followed by PMDA (23%), TGA (20%) and Swissmedic (10%). For the 7 NASs only approved by EMA, 43% were approved by TGA, followed by PMDA (29%), Swissmedic (29%) and Health Canada (14%). In general, NASs from a top companies (R&D budget> 3 billion USD in 2016) initially approved by EMA and FDA, had a higher proportion of approval in the other 4 agencies (~50-60%), compared with those approved by non-top companies (~20-30%). 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; Top company: Pharmaceutical company with R&D spending>3 billion USD in 2016 (http://www.pharmexec. com/2016-pharm -exec-50). From: Bujar M, McAuslane N, Liberti L. 2017. R&D Briefing 65: New drug approvals in six major authorities 2007 – 2016: Focus on the internationalisation of medicines. Centre for Innovation in Regulatory Science. London, UK. For more trends and analysis, please download the full CIRS R&D Briefing 65: http://www.cirsci.org/wp-content/uploads/2017/11/CIRS-RD-Briefing-65-20112017.pdf 30 approved only by FDA 7 approved X 23 not approved 8 approved X 22 not approved 3 approved X 27 not approved 6 approved X 24 not approved 7 approved only by EMA 2 approved X 5 not approved 1 approved X 6 not approved 2 approved X 5 not approved 3 approved X 4 not approved Health Canada PMDA Swissmedic TGA © CIRS, R&D Briefing 65