英文【EFPIA】2025年欧洲障碍门户网站-报告摘要

European Access Hurdles Portal:Summary of the third external reportMay 20252The industry created the European Access Hurdles Portal to add new information to the debate on availability of innovative medicinesCreated in April 2022, the role of the Portal is to improve transparency regarding the root causes of unavailability and delay, including the role of the environment and its corresponding impact on commercial decision-makingNovelty of the dataThe reason whycompany has not filed for P&R inparticularmarketThe reason why there isdelay in the decision of Pricing andReimbursementRoot cause of unavailability and delayApplication for P&Ror Filing informationMarketing status information Ex-post information to be collected through EFPIA’s PortalTargeting European AccessEFPIA’s WAIT has information on availability anddelayIRIS portal collects information on marketingstatus for all CAPsEx-anteinformationcollectedonplannedavailability through DG Sante’s pilotApril 2023 – Release of the first public report from the Portal 2010 – First report on the Patients W.A.I.T. (Waiting to Access Innovative Therapies) Indicator April 2022 – Industry commitment to the creation of the European Access Hurdles Portal2020 onwards – Annual reporting on Patients W.A.I.T. Indicators and root causes of unavailability June 2024 – Release of the second public report from the Portal May 2025 – Release of the third public report from the Portal 3Results indicate a complete willingness from industry to provide more transparency on the root causes of unavailabilityIndustry participationData completeness and representativenessTherapy areas of products approved by the EMA between Jan 2021-Jun 2024Therapy areas of products included in the Portal dataset between Jan 2021-Jun 2024The therapy areas of Portal products and the composition of products approved by the EMA over the same time period are similar – suggesting the products within the Portal are representative of the types of innovative medicines approved by the EMA over this periodAbbreviations: EFPIA = European Federation of Pharmaceutical Industries and Associations; EMA = European Medicines Agency94Data on 94 products were submitted to the Portal.All received European marketing authorisation between January 2021 and June 2024.All 35 EFPIA member companies with eligible products submitted data to the Portal (100% participation)The analysis described in this report is therefore representative of 100% of all products approved by the EMA between January 2021 and June 2024 that are marketed by EFPIA members100%100%4This report presents an updated analysis focusing on a set of key research questions Speed of marketing authorisationStatus of filing, availability and accessibilitySpeed of filing and reimbursementRoot causes of delaysOf all new products approved by international regulators between January 2021 and June 2024, EMA approval came later, on average, than the US and by Japan by 252 days and 24 days respectivelyHow does Europ