2021-2025年度监管审批指标

Regulatory approvalassessments in theEU and comparatorcountries Annual analysis Published May 2026 Regulatory approvals were measuredon the basis ofall novelactive substances approved in at least one of 7 countries Product scoping and methodology Methodology notes / caveats: •Novel active substances (NASs) that were approved in the U.S., EU, UK, China, Japan, Canada and Switzerland from 2021-2025 wereselected separately and then combined for the total product list of649 NASs. Medicines are considered a NAS if at least one active ingredient has not been previously marketed globally (therefore,products that have been included in the EFPIA WAIT indicator that arenot NASs, e.g. orphan medicines that are not NAS, are not in this scope).•Medicines approved in at least one of the seven countries were included within the scope of the analysis. For instance, FDA approvals includes NAS that have not been approved by the EMA, HealthCanada, PMDA, NMPA, MHRA, orSwissmedic.•Marketingauthorisation withdrawals are excluded (removed) from the analysiswhereknown and visible in published data.•Data accurate as of April 2026. Total number of regulatory approvals by region (2021-2025) Thetotal number of regulatory approvals by regionis the number of innovative medicinesapproved between 1stJanuary 2021 and 31stDecember 2025, split by the regulatory agency grantingmarketing authorisation in Europe, the US and a group of comparator countries. An ‘UpSetplot’ is an alternative to a Venn diagram forvisualising intersecting sets, especially for data with >3 sets How to read an ‘UpSet’ plot Only a fraction of medicines are approved in all regions, China,and the US have many products not approved elsewhere Total number of regulatory approvals by region (2021-2025)(by cohort) Thetotal number of regulatory approvals by regionis the number of innovative medicinesapproved between 1stJanuary 2021 and 31stDecember 2025, split by the regulatory agency grantingmarketing authorisation in Europe, the US and a group of comparator countries. Total number of single vs multi-indication approvals by region(2021-2025) Thetotal number of single-and multi-indication approvalsis the number of innovative medicinesapproved between 1stJanuary 2021 and 31stDecember 2025 for one indication only (single-indication) ormore indications over time (multi-indication), split by the regulatory agency granting marketingauthorisation in Europe, the US and a group of comparator countries. Total number single vs multi-indication approvals by region(2021-2025)(by cohort) Thetotal number of single-and multi-indication approvalsis the number of innovative medicinesapproved between 1stJanuary 2021 and 31stDecember 2025 that have received one or more post-approval extensions of indication, split by the regulatory agency granting marketing authorisation inEurope, the US and a group of comparator countries. CONTACT US Max Newton, Principal, Global Strategic Partnersmaximilian.newton@iqvia.com Marco Travaglio, Consultant, GS&ARmarco.travaglio@iqvia.com Kelsey Stoddart, Sr Consultant, GS&ARkelsey.stoddart@iqvia.com Emily Heron, Analyst, GS&ARemily.heron@iqvia.com