ArticleBMJ open2023
Comparison of novel oncology drugs that received dual approval from the US accelerated approval and EU conditional marketing authorisation pathways, 2006-2021: a cross-sectional study.
Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.
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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
14 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Pooled it
- Potential surrogate endpoint for B-cell hematologic malignancy: A systematic review and meta-analysis.Scientific reports · 2025Pooled it
- International approval of Chinese pharmaceuticals: a USA-anchored analysis with comparative insights from Europe and other markets.EClinicalMedicine · 2026Article
- Review
- FDA first to global follow-on: alignment in expedited oncology approvals across EMA, TGA, and PMDA.Frontiers in pharmacology · 2026Article
- Cross-jurisdictional access to innovative drugs and devices: a five-year policy and practice review of the Hong Kong and Macao medicine and equipment connect in the Greater Bay Area of China.Frontiers in medicine · 2026Article
- Comparison of drug approvals of the FDA and EMA between 2013 and 2023.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Comparison of the conditional approvals for anticancer drugs supported by single-arm trials in China and the United States: clinical evidence, post-marketing requirements, and regulatory outcomes.Frontiers in pharmacology · 2026Article
- Do conditional marketing authorisations actually accelerate patient access? Time-to-access of conditional vs. standard marketing authorisations in Italy, Spain, and Germany.Journal of pharmaceutical policy and practice · 2026Article
- US FDA-accelerated approvals and subsequent withdrawals: influence on Japanese clinical oncology practice guidelines.Investigational new drugs · 2025Article
- New systemic treatment paradigms in advanced biliary tract cancer and variations in patient access across Europe.The Lancet regional health. Europe · 2025Review
- Promoting the development and approval of new traditional Chinese medicines in China: a pooled analysis of data from 2013 to 2024.Frontiers in medicine · 2025Article
- Disparities in the access to immune checkpoint inhibitors approved in the United States, the European Union and mainland China: a serial cross-sectional study.BMJ public health · 2025Article
- Characteristics, clinical evidence and implementation effects of conditional approvals for drugs in China, a pooled analysis from 2020 to 2023.Frontiers in pharmacology · 2025Article
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveWe aimed to provide insight into differences in drug review decisions made by the US Food and Drug Administration's (FDA) accelerated approval (AA) pathway and the European Medicines Agency's (EMA) conditional marketing authorisation (CMA) pathway, and to add to the current knowledge base of drug approval processes. DESIGN, SETTING,
participantsThis cross-sectional study thoroughly examines novel oncology drugs with dual approval through FDA AA and EMA CMA between 2006 and 2021. Statistical analysis was performed from June to July 2022. PRIMARY AND SECONDARY OUTCOME MEASURES: The study examined the regulatory differences between regions for dually approved novel oncology drugs, including approval decisions, pivotal efficacy clinical trials, speed of review and postmarketing obligations.
resultsDuring this time period, there was a difference in the use of the FDA AA and the EMA CMA (FDA: EMA: 41.2%: 70.0%, p<0.05). Of the 25 drugs approved by both the FDA AA and the EMA CMA, 22 (88.0%) of the regulatory decisions were based on the same pivotal clinical trials. But there were more differences in the requirements for postmarketing obligations, with the EMA's postmarketing obligations focusing on the efficacy and safety of the drug (EMA: FDA: 63.0%: 27.0%, p＜0.05) and the FDA's postmarketing obligations focusing more on the efficacy (FDA: EMA: 73.0%: 23.9%, p＜0.05). In addition, both the USA and EU had some postmarketing obligations completed beyond the schedule (30.4% and 19.2% in the USA and EU, respectively), with the longest delays lasting 3.7 years (0.2-3.7 years) and 3.3 years (0.04-3.3 years) in the USA and EU, respectively.
conclusionsThe FDA and EMA have different orientations and benefit-risk balance considerations in the use of AA or CMA. It is also the case that the shortcomings in the design and implementation of postmarketing studies have made it a challenge to obtain the evidence needed to confirm a drug's benefits.
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