监管审批指标季度QTR1 2026

Regulatory approvalassessments in theEU and comparatorcountries Quarterly analysis Published May 2026 The quarterly regulatory approval tracker measures localapprovals relative to total FDA approvals (2021-2026*) Product scoping and methodology otes / caveats: •Novel active substances (NASs) that were approved in the U.S. from2021-2026*resulting in atotal product list of258NASs.The approvals of these in scope products weretracked across the six comparator countries (timeframe of local regulatory approvals was not limited to 2021-2026*). •Medicines are considered a NAS if at least one active ingredient has not been previously marketed globally (therefore, productsthat have been included in the EFPIA WAITindicator that are not NASs, e.g. orphan medicines that are notNASs, are not in this scope).•*2026 approvals includeNASsapprovedby the FDAbetween Jan 1stand 28thFeb 2026.•Marketing authorisation withdrawals are excluded (removed) from the analysis where known and visible in published data.•Data accurate as of April 2026. Between 2021 and 2025, Europe’s share of yearly FDAapprovals has fallen from 77% to 38% Note: The analysis tracks whether NAS approved by the FDA inany given year subsequently receive approval in othercountries. Thus, earlier cohorts are likely to show higherpercentages as they will have been on the market for longer. Interpretation •Lower percentage of FDA approvals in some countries can sometimes reflect ahigher share orphan or oncology products approvalsby the FDA•Higher % indicate greater alignment with the FDA, meaning a larger % of medicines approved by the FDA are also approved in other countries•Year on year changes are impacted byregulatory timing differences: approvals may lag in some countries due to delays in approval procedures Measuring monthly data on a 12-month rolling basis shows thatEurope’s decline in approvals accelerates in H2 2025 Interpretation •A declining trend over time indicates that the country isfalling further behind FDA approvals, while an increasing trend shows greater convergence•Higher values indicategreater alignment with FDA approvals, meaning more FDA-approved medicines are available in the comparator countries•Lower values suggest alarger approval gap, meaning a greater share of FDA-approved medicines are not yet authorized 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 Appendix FDA approved New Actives Substances (NASs) in 2024 (1 of 4) Approval dates across all regions Approval dates across all regionsFDA approved New Actives Substances (NASs) in 2024 (2 of 4) FDA approved New Actives Substances (NASs) in 2024 (3 of 4) Approval dates across all regions Approval dates across all regionsFDA approved New Actives Substances (NASs) in 2024 (4 of 4) FDA approved New Actives Substances (NASs) in 2025 (1 of 4) Approval dates across all regions Approval dates across all regionsFDA approved New Actives Substances (NASs) in 2025 (2 of 4) FDA approved New Actives Substances (NASs) in 2025 (3 of 4) Approval dates across all regions Approval dates across all regionsFDA approved New Actives Substances (NASs) in 2025 (4 of 4) Approval dates across all regionsFDA approved New Actives Substances (NASs) in 2026 (1 of 1)