Use of the conditional marketing authorization pathway for oncology medicines in Europe is a research paper published in Clinical Pharmacology & Therapeutics (2015). On theSindex it has a DataRank of 3.7. It has been cited 57 times, with 46 citing works in its 1-hop citation network.
Conditional marketing authorization (CMA) in the European Union (EU) is an early access pathway for medicines that show promising therapeutic effects, but for which comprehensive data are not available. Using a mixed quantitative‐qualitative research design, we evaluated how CMA has been used in marketing authorization of oncology medicines in the period 2006 to 2013. We show that compared to full marketing authorization, CMA is granted based on less comprehensive data. However, this is accompanied by significantly longer assessment times and less consensus among regulators about marketing authorization. Moreover, development time from first‐in‐human testing to marketing authorization did not differ between full marketing authorization and CMA, but was significantly longer for CMA compared to accelerated approved products in the United States (US). Results indicate that CMA is not used by companies as a prospectively planned pathway to obtain early access, but as a “rescue option” when submitted data are not strong enough to justify full marketing authorization.
FAIR checklist signals are shown for context only and do not affect DataRank scoring.
Base Score Contribution
0.609
From this paper's citation signal
Citation Network Contribution
3.1
From 37 citing papers with measurable signal
Ranked by citation count — the same ordering the engine uses when summing log1p(Cq) over citers.
DataRank blends this paper's own citation count with the influence of the papers that cite it. Here, roughly 17% comes from its base citations and 83% from the citation network (37 citing papers contributed measurable signal).
Citers are pulled from OpenAlex sorted by cited_by_count:descand capped per paper, so when the cap binds we keep the highest-signal references and the score is reproducible across reruns.
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