ArticleTherapeutic innovation & regulatory science2026
Methods for Assessing Therapeutic Innovation of Drugs: Changes at the Italian Medicine Agency.
Article in Therapeutic innovation & regulatory science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionTherapeutic drug innovation is a fundamental point for patients, healthcare professionals, and national health services. In Europe, the assessment of the therapeutic innovation of drug is establish to the individual national health agencies. In Italy, the Italian Medicines Agency (AIFA) was the first to adopt an algorithm for assessing the degree of therapeutic innovation of drugs in 2007. Afterwards, the AIFA has been issuing various versions of a method of assessment of therapeutic innovations, the most recent one being that issued in September 2025.
aimTo compare the results of the assessment of therapeutic innovation of drugs recently authorized by the European Medicines Agency (EMA), by using the former method (here called AIFA2007) vs the present one (here called AIFA2025), in order to determine which of the two was more selective.
results38 new medicines authorized by the EMA between June 2023 and 2025 were evaluated. Among those analyzed with AIFA2007, only 3 achieved a degree of "important" therapeutic innovation (8%). Based on AIFA2025 criteria, as many as 12 drugs were classified as innovative (32%).
conclusionThe 2007 algorithm appeared to be much more selective in comparison to the recent one AIFA2025.
Indexed as
Identifiers
42455416What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.