ArticleEuropean journal of clinical pharmacology2016
Do the EMA accelerated assessment procedure and the FDA priority review ensure a therapeutic added value? 2006-2015: a cohort study.
Article in European journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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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.
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Who cites it
10 citing papers in PubMed.
- Identifying Factors Associated with the Acquisition of Multiple Indications for Anticancer Drugs.Current oncology (Toronto, Ont.) · 2026Observational
- Facts and Issues of Submitting Applications (Public Knowledge-Based Applications) for Unapproved and Off-label Drugs With High Medical Needs in Japan.Current therapeutic research, clinical and experimental · 2026Article
- Current landscape of innovative drug development and regulatory support in China.Signal transduction and targeted therapy · 2025Review
- Pharmaceutical Company's Choices of Indication for the First Clinical Projects in Oncological Drug Development in the United States.Therapeutic innovation & regulatory science · 2025Article
- Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations.Therapeutic innovation & regulatory science · 2024Article
- The role of drug regulatory authorities and health technology assessment agencies in shaping incentives for antibiotic R&D: a qualitative study.Journal of pharmaceutical policy and practice · 2023Article
- Initial and supplementary indication approval of new targeted cancer drugs by the FDA, EMA, Health Canada, and TGA.Investigational new drugs · 2022Article
- Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States.The Milbank quarterly · 2020Article
- Food and Drug Administration vs European Medicines Agency: Review times and clinical evidence on novel drugs at the time of approval.British journal of clinical pharmacology · 2020Article
- Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union.Journal of tissue engineering and regenerative medicine · 2018Article
Corrections and comments
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Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have both implemented procedures in order to shorten review time for marketing authorizations with potential therapeutic added value, called priority review and accelerated assessment procedure, respectively. The aim of this study is to compare the new molecular entities (NME) assessed in shorter review time by both agencies and to investigate whether granting a shorter review time status subsequently predicts its therapeutic value attributed by a health technology assessment agency, the French Haute Autorité de Santé (HAS).
methodsAll NME approved by the EMA and the FDA with a therapeutic added value between 2007 and June 30, 2015 were extracted. We assessed the sensibility, the positive predictive value, and the EMA review time.
resultsOne hundred seventy-eight NME were approved by the FDA and the EMA and a therapeutic value was available for 160 NME. Eighty-eight (55.0 %) NME were on FDA priority review, 24 (15.0 %) on EMA accelerated procedure and 43 (26.9 %) were considered of high clinical added value. The sensibility was 86.0 % for the FDA and 30.2 % for the EMA. The positive predictive value was, respectively, 42.0 and 54.2 %. Twenty-five NME on FDA priority review and of high therapeutic added value were not on EMA accelerated assessment procedure, leading to a supplementary mean EMA review time of 146 days.
conclusionThe EMA was restrictive to grant a shorten review time status for products with therapeutic interest during the study period.
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