ArticleInternational journal of clinical oncology2023
Oncology drug lag in Japan: has it improved over the last decade?
Article in International journal of clinical oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 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
9 citing papers in PubMed, 15 citations in OpenAlex.
- Reimagining Early-Phase Clinical Development in Japan: From Regulatory Obligation to Global Acceleration.Clinical and translational science · 2026Article
- Trends in and Determinants of Approval Lag for Anticancer Drugs in Japan and the US: Role of Multi-Regional Trials and Concurrent Approvals.Clinical and translational science · 2025Article
- Regulatory Disparities Between US Accelerated Approval and Japanese Authorization of Oncology Drugs: An Analysis of Evidence Quality.Clinical and translational science · 2025Article
- Evaluation of drug lag and drug loss in Japan: participation in global phase III oncology trials.International journal of clinical oncology · 2025Article
- Evolving Research and Development Landscape for Rare Diseases: Growing Concerns Over Orphan Drug Lag in Japan.Clinical pharmacology and therapeutics · 2025Article
- Characteristics of Drugs from Non-Global Companies for Hematologic Malignancies and Impact on Global Regulatory Approval.Clinical pharmacology and therapeutics · 2025Article
- Different Development Strategies Affecting Japan's Drug lag between Japan-Based and Foreign-Based Companies.Therapeutic innovation & regulatory science · 2024Article
- Trends in oncology drug lags in Japan from 2001 to 2020: A cross-sectional study.Clinical and translational science · 2023Article
- An Empirical Analysis of Anti-Cancer Drug Lags in South Korea.Inquiry : a journal of medical care organization, provision and financingArticle
Corrections and comments
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Authors and funding
2 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundExisting studies and statistics on the drug lag between Japan and the United States (US) for anti-cancer drugs indicate that it has decreased, whereas more drugs are left unapproved in Japan. This study aimed to quantify the impact of unapproved drugs on the drug lag.
methodsInformation on 136 anti-cancer drugs approved in the US between 2011 and 2022 was collected. The approval lag, defined as the number of days from the date of approval in the US to the date of approval in Japan, was calculated for all selected drugs, and the median was calculated using the Kaplan-Meier method. The approval lag for drugs not approved in Japan was treated as censored data. Factors potentially associated with the approval lag were explored using Cox regression analysis.
resultsThe median approval lags for the first half-period (2011-2016) and the last half-period (2017-2022) were 961 days (2.6 years) and 1547 days (4.2 years), respectively (Log-rank test: p = 0.0687). The participation of Japan in the global pivotal trial was associated with a shorter approval lag, and new drug applications by non-Japanese companies that did not rank in the global sales top 20 were associated with a longer approval lag.
conclusionsDrug lag has not decreased over the last decade. The percentage of pivotal trials for US approval that included Japan has increased but should be further increased in the future. Japan may require a scheme to encourage smaller non-Japanese companies to include Japan in their global clinical development plan.
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