ASSESSING THE IMPACT OF US MFN POLICY ON EMA APPROVAL TIMING FOLLOWING FDA APPROVAL: AN EXPLORATORY ANALYSIS
Author(s)
Samira Abdi Mohamed, BSc, Maisie Ballsdon, BSc, Tracey Tingle, BSc.
WEP Clinical, London, United Kingdom.
WEP Clinical, London, United Kingdom.
OBJECTIVES: The United States (US) Most Favoured Nation (MFN) policy seeks to align domestic drug prices with those in economically comparable countries, including several European Union member states. Since the MFN policy announcement, concerns have emerged that the policy may incentivise manufacturers to delay European regulatory filings to avoid lower international reference prices. This study assessed whether MFN implementation was associated with changes in European Medicines Agency (EMA) approval following US Food and Drug Administration (FDA) approval.
METHODS: An exploratory descriptive analysis was conducted using publicly available FDA and EMA approval databases. Novel medicines (excluding indication extensions) with FDA approval between 1 May 2023 and 31 October 2023 were included in the pre-MFN cohort, while those approved between 1 June 2025 and 30 November 2025 comprised the post-MFN cohort. For each product, EMA marketing authorisation was assessed relative to FDA approval and classified as occurring within six months (timely) or beyond six months (delayed). Instances where EMA approval preceded FDA approval were also identified.
RESULTS: Nineteen FDA-approved medicines that also had EMA approval were identified in the pre-MFN cohort and sixteen in the post-MFN cohort. The analysis showed that the proportion of products receiving EMA approval within six months of FDA approval was similar pre-MFN and post-MFN (47% vs 50%). However, the number of delayed approvals beyond six months appeared to increase from 11% to 25% following MFN implementation. The analysis also indicated a decrease in the proportion of products approved by the EMA ahead of the FDA, from 37% pre-MFN to 25% post-MFN.
CONCLUSIONS: This analysis suggests that, while the overall proportion of FDA-approved medicines receiving timely EMA approval has remained stable following MFN implementation so far, there may be early signals of increasing delays in EMA approvals as a result of MFN policy. Further longitudinal analysis is warranted.
METHODS: An exploratory descriptive analysis was conducted using publicly available FDA and EMA approval databases. Novel medicines (excluding indication extensions) with FDA approval between 1 May 2023 and 31 October 2023 were included in the pre-MFN cohort, while those approved between 1 June 2025 and 30 November 2025 comprised the post-MFN cohort. For each product, EMA marketing authorisation was assessed relative to FDA approval and classified as occurring within six months (timely) or beyond six months (delayed). Instances where EMA approval preceded FDA approval were also identified.
RESULTS: Nineteen FDA-approved medicines that also had EMA approval were identified in the pre-MFN cohort and sixteen in the post-MFN cohort. The analysis showed that the proportion of products receiving EMA approval within six months of FDA approval was similar pre-MFN and post-MFN (47% vs 50%). However, the number of delayed approvals beyond six months appeared to increase from 11% to 25% following MFN implementation. The analysis also indicated a decrease in the proportion of products approved by the EMA ahead of the FDA, from 37% pre-MFN to 25% post-MFN.
CONCLUSIONS: This analysis suggests that, while the overall proportion of FDA-approved medicines receiving timely EMA approval has remained stable following MFN implementation so far, there may be early signals of increasing delays in EMA approvals as a result of MFN policy. Further longitudinal analysis is warranted.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR163
Topic
Health Policy & Regulatory
Topic Subcategory
Approval & Labeling, Pricing Policy & Schemes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas