Analysis of Historical European Medicines Agency (EMA) Marketing Authorization (MA) Timelines: Will EU Joint Clinical Assessment (JCA) Timelines Be Longer Than Expected?
Author(s)
Paula Skowron, MPharm1, Ajinkya Bendre, MSc2, Julieta Zlateva, MSc3, Vivek Chandola, BTech2, Vinay M Kanthi, MSc2, Peter Wagner, BMS4, Anke van Engen, MSc5, Sian Tanner, BA, PhD5, Edel Falla, MSc6, Ikhlaas M Kasli, PhD6.
1IQVIA, Warsaw, Poland, 2IQVIA, Bengaluru, India, 3IQVIA, Sofia, Bulgaria, 4IQVIA, Frankfurt, Germany, 5IQVIA, Amsterdam, Netherlands, 6IQVIA, London, United Kingdom.
1IQVIA, Warsaw, Poland, 2IQVIA, Bengaluru, India, 3IQVIA, Sofia, Bulgaria, 4IQVIA, Frankfurt, Germany, 5IQVIA, Amsterdam, Netherlands, 6IQVIA, London, United Kingdom.
OBJECTIVES: The European Joint Clinical Assessment (JCA) process will run in parallel to European Medicines Agency (EMA)’s marketing authorization (MA) process, leaving the health technology developers (HTDs) with limited time to prepare the JCA dossiers. The aim of this study was to analyze the median duration of EMA MA process and its milestones and compare them with the anticipated JCA timelines.
METHODS: We identified the European Public Assessment Reports (EPARs) for oncology products in their original indications, approved in standard EMA procedure, published between January 2018 and November 2024, using IQVIA’s Market Access Insights database and analyzed the timelines of the EMA MA process and its milestones. We compared the median timelines with the anticipated timelines of the EU JCA as per the Member State Coordination Group on Health Technology Assessment (HTA CG) Procedural Guidance for JCA Medicinal Products.
RESULTS: Based on an analysis of 92 identified EPARs, the median duration of EMA MA process (from submission to European Commission decision) was 428 days, ranging from 140 to 1,019 days. The number of clock-stops varied from 1 to 5, while most (66) EPARs included 2 clock-stops. The median duration of the first clock-stop was 85 days (range: 21 - 600 days), and 29 days for the second. When comparing the timelines to the EU JCA timelines, assessors could have a maximum of 222-241 days on average to complete the JCA report, 31-50 days more than anticipated in the HTA CG Procedural Guidance. However, recent EMA initiatives aimed at streamlining the MA process could potentially shorten this timeframe.
CONCLUSIONS: Our analysis indicates that assessors and co-assessors may have more time to develop the JCA report than anticipated in the HTA CG Procedural Guidance, which should allow them to accept the extension of a 100-day timeline for JCA dossier preparation, when needed.
METHODS: We identified the European Public Assessment Reports (EPARs) for oncology products in their original indications, approved in standard EMA procedure, published between January 2018 and November 2024, using IQVIA’s Market Access Insights database and analyzed the timelines of the EMA MA process and its milestones. We compared the median timelines with the anticipated timelines of the EU JCA as per the Member State Coordination Group on Health Technology Assessment (HTA CG) Procedural Guidance for JCA Medicinal Products.
RESULTS: Based on an analysis of 92 identified EPARs, the median duration of EMA MA process (from submission to European Commission decision) was 428 days, ranging from 140 to 1,019 days. The number of clock-stops varied from 1 to 5, while most (66) EPARs included 2 clock-stops. The median duration of the first clock-stop was 85 days (range: 21 - 600 days), and 29 days for the second. When comparing the timelines to the EU JCA timelines, assessors could have a maximum of 222-241 days on average to complete the JCA report, 31-50 days more than anticipated in the HTA CG Procedural Guidance. However, recent EMA initiatives aimed at streamlining the MA process could potentially shorten this timeframe.
CONCLUSIONS: Our analysis indicates that assessors and co-assessors may have more time to develop the JCA report than anticipated in the HTA CG Procedural Guidance, which should allow them to accept the extension of a 100-day timeline for JCA dossier preparation, when needed.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR24
Topic
Health Policy & Regulatory, Health Technology Assessment, Organizational Practices
Topic Subcategory
Approval & Labeling, Reimbursement & Access Policy
Disease
Oncology