ArticleInvestigational new drugs2019
The drug lag and associated factors for orphan anticancer drugs in Japan compared to the United States.
Article in Investigational new drugs, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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Who cites it
13 citing papers in PubMed, 28 citations in OpenAlex.
- Drug and country characteristics associated with global approval and launch of FDA-approved novel therapeutics.Health affairs scholar · 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
- Evaluation of drug lag and drug loss in Japan: participation in global phase III oncology trials.International journal of clinical oncology · 2025Article
- Pediatric-Specific Drug Loss Issue in Japan: Comparison of Pediatric Development Status Between Japan and the United States.Therapeutic innovation & regulatory science · 2025Article
- Characteristics of Drugs from Non-Global Companies for Hematologic Malignancies and Impact on Global Regulatory Approval.Clinical pharmacology and therapeutics · 2025Article
- Drug lag and associated factors of orphan drugs approved by the U.S. in China.Frontiers in pharmacology · 2025Article
- Factors Associated with Inclusion of Japan in Phase I Multiregional Clinical Trials in Oncology.Therapeutic innovation & regulatory science · 2024Article
- Access to Innovative Medicines: Regulation Change and Factors Associated with Drug Approval Lag in Malaysia.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
- Exploratory Analysis of Drug Lag in New Oncology Drugs Between Japan and the US.Therapeutic innovation & regulatory science · 2023Article
- Drug Lag and Associated Factors for Approved Drugs in Korea Compared with the United States.International journal of environmental research and public health · 2022Article
- Assessment of Drugs Approved by Public Knowledge-Based Applications (Kouchi-shinsei) During the Last Two Decades in Japan.Clinical pharmacology and therapeutics · 2021Article
- Use of unapproved or off-label drugs in Japan for the treatment of graft-versus-host disease and post-transplant viral infection.International journal of hematology · 2020Article
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Authors and funding
3 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The approval of orphan anticancer drugs in Japan has increased to meet high social demand. Drug lag, namely the approval lag of new drugs, is recognized as a social issue in Japan. We investigated the approval lag and its components, submission lag and review-time lag, between Japan and the United States (US) to reveal whether an approval lag still exists, and to identify potential factors that may contribute to reducing the approval lag. Anticancer drugs approved in Japan between April 2004 and November 2017 were investigated using publicly available information. Results showed that the median approval lag of orphan anticancer drugs in 2016-2017 was 727.0 days (interquartile range, IQR, 310.0-1054.3). The approval lag was significantly correlated with the submission lag (correlation coefficient = 1.00, P < 0.001) but not with the review-time lag (correlation coefficient = -0.16, P = 0.22). The submission lag was significantly longer for orphan anticancer drugs than non-orphan drugs (median, 712.5 days [IQR, 186.0-1448.3] vs. 387.0 days [92.8-1096.0], P = 0.023). External collaboration in drug development was associated with a longer submission lag (coefficient = 762.1, P = 0.017), while breakthrough therapy designation in the US was associated with a shorter submission lag (coefficient = -832.8, P = 0.035). In conclusion, we revealed that an approval lag for orphan anticancer drugs still existed in 2016-2017. A submission lag for orphan anticancer drugs was the main component affecting the approval lag, and was longer than that for non-orphan drugs. External collaboration in drug development may be a potential factor in reducing the submission lag for orphan anticancer drugs.
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