ArticleBritish journal of clinical pharmacology2020
Food and Drug Administration vs European Medicines Agency: Review times and clinical evidence on novel drugs at the time of approval.
Article in British journal of clinical pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.
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.
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Who cites it
24 citing papers in PubMed.
- Advanced therapy medicinal products (ATMPs) - An analysis of the global regulatory status.British journal of clinical pharmacology · 2026Article
- Beyond the Amyloid Hypothesis: Systemic Drivers, CNS-PNS Crosstalk, and the Future of Alzheimer's Disease Therapeutics.International journal of molecular sciences · 2026Review
- Clinical Benefit of Multiple Myeloma Drugs at Regulatory Approval in Brazil, Europe, and the USA: A Retrospective Cohort Study (2003-2024).Clinical drug investigation · 2026Article
- Article
- Phase I clinical trials for cardiovascular diseases in Europe: analysis of trends, distribution, and regulatory context.Frontiers in pharmacology · 2026Article
- Current landscape of innovative drug development and regulatory support in China.Signal transduction and targeted therapy · 2025Review
- Public perceptions of high-cost cancer drugs and the implications for reimbursement decisions.Health economics review · 2025Article
- An Editorial on the Special Issue "Where Are We Now and Where Is Cell Therapy Headed?"Pharmaceutics · 2025Article
- Innovative Formulation Strategies for Biosimilars: Trends Focused on Buffer-Free Systems, Safety, Regulatory Alignment, and Intellectual Property Challenges.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Cancer drug applications to the EMA and the FDA: A comparison of new drugs and extension of indication in terms of approval decisions and time in review.British journal of clinical pharmacology · 2025Article
- Iron oxide based magnetic nanoparticles for hyperthermia, MRI and drug delivery applications: a review.RSC advances · 2025Review
- Dangers of under-treatment and over-treatment with inhaled corticosteroids in children with asthma.Pediatric pulmonology · 2025Article
- Nanomedicine in Ophthalmology: From Bench to Bedside.Journal of clinical medicine · 2024Review
- From Drug Discovery to Drug Approval: A Comprehensive Review of the Pharmacogenomics Status Quo with a Special Focus on Egypt.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Digital Twin Fundamentals of mRNAACS omega · 2024Article
- 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
- Clinical development and marketing application review times for novel orphan-designated drugs.Frontiers in medicine · 2024Article
- Recent Advances in the Determination of Veterinary Drug Residues in Food.Foods (Basel, Switzerland) · 2023Review
- 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
- A detailed analysis of expedited regulatory review time of marketing authorization applications for new anticancer drugs in the US and EU.Clinical and translational science · 2022Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The Food and Drug Administration (FDA) and European Medicines Agency (EMA) now have expedited review procedures for new drugs. We compared the review times of medicines licensed by the 2 agencies and explored differences in the evidence submitted. In 2015-2017 the FDA licensed 113 drugs, 66 of which reached Europe. The median review time was longer at the EMA than FDA and was shorter for drugs undergoing FDA-expedited programmes compared to the same drugs approved by the EMA through the standard procedure. We identified differences regarding the evidence submitted to the 2 regulators for 7 drugs. The greater use of expedited programmes by the FDA and administrative time at the European Commission mainly explain the later access of new drugs to the European market. The additional evidence submitted to the EMA is generally scant and limited to a few drugs.
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What 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.