CRA:2024年欧洲药物和医疗设备准入障碍和挑战综览报告(英文版)(26页).pdf

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CRA:2024年欧洲药物和医疗设备准入障碍和挑战综览报告(英文版)(26页).pdf

1、 Page 1 European Access Hurdles Portal:Results from the second year of data collection June 2024 Executive Summary In April 2022,EFPIA and its members committed to a series of actions designed to reduce disparities in access across Europe.The European Access Hurdles Portal(the“Portal”)was launched t

2、hen as an industry-led initiative to increase transparency regarding the root causes of unavailability of innovative medicines in Europea key issue affecting patient access to innovative medicines.It is intended to identify and report on the multifactorial root causes of delays in pricing and reimbu

3、rsement(P&R)filing or the reimbursement decision-making process for European Union(EU)centrally approved medicines in their first indication.This allows data on delay and lack of availability to be put into context and thereby supports a shared understanding of these root causes and the collective r

4、esponsibility to address these issues.The Portal can be used to support a multi-stakeholder dialogue to devise solutions that can address these challenges holistically.Figure 1:New information on unavailability and delay Novelty of the dataThe reason why a company has not filed for P&R in a particul

5、armarketThe reason why there is a delay 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 EFPIAs PortalTargeting European AccessEFPIAs WAIT has information

6、on availability anddelayIRIS portal collects information on marketingstatus for all CAPsEx-anteinformationcollectedonplannedavailabilitythrough DGSantes pilot Charles River Associates Page 2 This is the second report using evidence from the Portal.The evidence now includes data collected on medicine

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