Analysis of the success rates of new drug development in Japan and the lag behind the US

Hirai, Yasuaki; Yamanaka, Yasunari; Kusama, Makiko; Ishibashi, Tomoko; Sugiyama, Yuichi; Ono, Shunsuke

doi:10.1016/j.healthpol.2011.11.008

Cited by 21 publications

(23 citation statements)

References 14 publications

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“…The previous study reported that drugs from foreign‐capital pharmaceutical companies were showing drug lag . In a subsequent study, the authors also reported that the paradoxical advantageous effect of drug lag on development success may explain the delays in development and launch in Japan . Although pharmaceutical companies need to have a reasonable choice of strategies for developing new drugs, the regulatory authorities should provide reasonable guidance to have a positive impact, even on the foreign‐capital companies’ strategic decisions.…”

Section: Discussionmentioning

confidence: 99%

Utilization of the Bridging Strategy for the Development of New Drugs in Oncology to Avoid Drug Lag

Kogure

Koyama

Hidaka

2017

The Journal of Clinical Pharma

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Global trial (GT) strategy and bridging (BG) strategy are currently the main clinical development strategies of oncology drugs in Japan, but the relationship between development style and drug lag and how the bridging strategy has contributed to the solution of drug lag have not been clear. We investigated the potential factors that influenced submission lag (SL), and also compared the differences in SL among early-initiation BG strategy, late-initiation BG strategy, and GT strategy. A stepwise linear regression analysis identified the potential factors that shorten SL: development start lag and development style. Comparison of the differences in SL among the strategies also indicated that the SL in the GT strategy and that in the early-initiation BG strategy were significantly shorter than that in the late-initiation BG strategy. The findings in our study suggest that the late-initiation BG strategy may not contribute to shortening drug lag. Because the number of late-initiation BG studies has not decreased, we propose first that pharmaceutical companies should initiate clinical development as early as possible in Japan so that they can choose the GT strategy as a first option at the next step, and second when they cannot choose the GT strategy after investigating differences in exposure between Japanese and non-Japanese in a phase 1 study, they should select the early BG strategy to avoid future drug lag. It is also important for the regulatory authorities to provide reasonable guidance to have a positive impact on strategic decisions, even for foreign-capital companies.

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Section: Discussionmentioning

confidence: 99%

Utilization of the Bridging Strategy for the Development of New Drugs in Oncology to Avoid Drug Lag

Kogure

Koyama

Hidaka

2017

The Journal of Clinical Pharma

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“…Second, another reason could have been the delay in Japan of licensing new drugs or new indications [21], especially in neulological [22] and psychiatric [23] medications. Apart from sildenafil, Japanese regulatory process was notoriously slow.…”

Section: Discussionmentioning

confidence: 99%

Thirty years of scientific research on second-generation antipsychotic drugs in Japan: A bibliometric analysis

López‐Muñoz¹,

Shinfuku²,

Shen³

et al. 2013

OJPsych

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Aims: Research on second-generation antipsychotic drugs (SGAs) has experienced great development in last decades. We did a bibliometric study on the scientific publications on SGAs in Japan. Methods: With the EMBASE and MEDLINE databases, we chose papers published from Japan with SGA descriptors. Price's law and Bradford's law has been used as bibliometric indicators for quantitating production and dispersion, respectively, of published papers on SGAs. We also calculated the participation index of different countries, and correlated those bibliometric data with some social and health data from Japan (such as total per capita expenditure on health and gross domestic expenditure on research and development). Results: A sum of 669 original documents were published from Japan from 1982 to 2011. Those results fulfilled Price's law, with scientific production on SGAs showing exponential growth (correlation coefficient r = 0.9261, as against an r = 0.8709 after linear adjustment). The most studied SGAs in Japan were risperidone (n = 192), aripiprazole (n = 109), and olanzapine (n = 106). Division of documents into Bradford zones yielded a nucleus occupied exclusively by the Progress in Neuro-Psychopharmacology and Biological Psychiatry (49 articles). Those publications were in 157 different journals. Seven of the first 10 frequently used journals had an impact factor of being greater than 3. Conclusions: The SGA publications in Japan have been through exponential growth over the studied period, without evidence of reaching a saturation point.

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“…In Japan, approval of a new drug abroad that is not approved for use in Japan has become a major issue [1][2][3][4][5][6][7][8]. This problem has been termed drug lag, and its direct cause includes delays in the start of clinical development, the progress of clinical trials, and in the regulatory review.…”

Section: Objectivementioning

confidence: 99%

What Factors Lead to Prolonged Regulatory Review Times for New Drugs in Japan?

Yoneda¹,

Asada

Shimizu³

et al. 2015

J Clin Trials

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Objective: Among all the new drugs approved in Japan, the regulatory review time for some greatly exceeds the median each year. However, to our knowledge, no reports have detailed why the review times were prolonged in these instances. In this study, we examined new applications (NDAs) whose review times were more than twice as long as the median each year in order to pinpoint the cause of delayed approval. Methods:We analyzed 564 NDAs that were approved in Japan between 2005 and 2011.Results: Thirty-eight NDAs were found to have prolonged review times. Of the 38 NDAs, the most popular therapeutic categories were oncology drugs and vaccines, and 28 of the drugs had already been approved in foreign countries when approval was granted in Japan, some with lag times of more than 36 months. This observation suggests that prolonged regulatory review time further worsens lags in drug approval. "Problem related to clinical data" was cited as the most common reason for prolonged review time. For most of the NDAs categorized into this group, additional clinical trials were conducted during the same review time without NDA withdrawal because the clinical study design was inappropriate, a deficiency in the evidence of a dosage regimen was observed, or efficacy was not confirmed in a confirmatory study trial. Conclusion:Our analyses of these trial details indicate the importance of determining the optimal dosage regimen carefully and utilizing objective endpoints in clinical trials.Keywords: Regulatory review; Drug development; Clinical trial; Drug lag; New drug applications; Regulatory review times; Access gap ObjectiveIn Japan, approval of a new drug abroad that is not approved for use in Japan has become a major issue [1][2][3][4][5][6][7][8]. This problem has been termed drug lag, and its direct cause includes delays in the start of clinical development, the progress of clinical trials, and in the regulatory review. In order to minimize these delays, the Japanese regulatory authorities, the Ministry of Health, Labour and Welfare (MHLW), and the Pharmaceuticals and Medical Devices Agency (PMDA), have conducted several projects [9]. As a result, the PMDA has shortened the average review time to

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Analysis of the success rates of new drug development in Japan and the lag behind the US

Cited by 21 publications

References 14 publications

Utilization of the Bridging Strategy for the Development of New Drugs in Oncology to Avoid Drug Lag

Utilization of the Bridging Strategy for the Development of New Drugs in Oncology to Avoid Drug Lag

Thirty years of scientific research on second-generation antipsychotic drugs in Japan: A bibliometric analysis

What Factors Lead to Prolonged Regulatory Review Times for New Drugs in Japan?

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