Formal dissent in CHMP opinions on new medicines, 2020-2025

From 2020–2025, CHMP divergent positions were appended to 28 of 331 positive opinions (8.5%), most often citing efficacy and methodological limitations.

• Why it matters: Public records rarely show disagreement at the moment CHMP adopts an opinion, limiting visibility into regulatory uncertainty for downstream decision-makers.
• What they did: The study reviewed divergent positions formally appended to CHMP opinions on new medicines (2020–2025), quantifying frequency, minority size, and the issues raised across positive and negative outcomes.
• The result: Among 22 publicly available final negative opinions, 6 (27%) included a divergent position favoring authorization, enabling indexing of disagreements and publication of vote outcomes to inform treatment and coverage decisions.

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