ArticleDrug design, development and therapy2025
New Drug Approvals in China: An International Comparative Analysis, 2019-2023.
Article in Drug design, development and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
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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
5 citing papers in PubMed.
- Landscape of diabetic kidney disease drug clinical trials in China (2013-2023): global implications for innovation and policy.Renal failure · 2026Review
- The evolving landscape of drug targets.Nature reviews. Drug discovery · 2026Review
- Development Timelines of Innovative Drugs in China: A 15-Year Cross-Sectional Analysis of Characteristics and Influencing Factors.Clinical and translational science · 2026Article
- International approval of Chinese pharmaceuticals: a USA-anchored analysis with comparative insights from Europe and other markets.EClinicalMedicine · 2026Article
- A cross-national review of novel oncology approvals in the United States and China (2020-2025).Health affairs scholar · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Purpose: Over the past five years, China's pharmaceutical industry has rapidly developed but still lags behind global leaders. This study aims to analyze and compare the trends in new drug approvals in China, the United States (US), the European Union (EU), and Japan from 2019 to 2023. Methods: Data on new drug approvals were collected from the National Medical Products Administration (NMPA), Food and Drug Administration (FDA), European Medicines Agency (EMA), and Pharmaceuticals and Medical Devices Agency (PMDA), including information on the generic name, trade name, applicants, target, approval date, drug type, approved indications, therapeutic area, the highest R&D status in China, and special approval status. The approval time gaps between China and other regions were calculated. Results: From 2019 to 2023, China led with 256 new drug approvals, followed by the US (243 approvals), the EU (191 approvals), and Japan (187 approvals). Oncology, hematology, and infectiology were identified as the leading therapeutic areas globally and in China. Notably, PD-1 and EGFR inhibitors saw substantial approval, with 8 drugs each approved by the NMPA. China significantly reduced the approval timeline gap with the US and the EU since 2021, approving 15 first-in-class drugs during the study period. Conclusion: Despite COVID-19 challenges, China has improved in both the quantity and speed of new drug approvals, narrowing timeline gaps with major markets and enhancing its global pharmaceutical presence.
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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.