Delays in psychiatric drug development in Japan

Shimazawa, Rumiko; Kusumi, Ichiro; Ikeda, Masayuki

doi:10.1111/j.1365-2710.2011.01311.x

Cited by 15 publications

(18 citation statements)

References 18 publications

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“…Apart from sildenafil, Japanese regulatory process was notoriously slow. For example, the first selective serotonin reuptake inhibitor (SSRI), fluvoxamine, was marketed in Japan in 1999, and second SSRI, paroxetine, in 2001 [23,24]. Japanese regulatory authority released the marketing licence of clozapine in 2009, and authorized olanzapine and aripiprazole for the indication to treat acute mania in 2012 [23].…”

Section: Discussionmentioning

confidence: 99%

“…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%

“…Japanese regulatory authority released the marketing licence of clozapine in 2009, and authorized olanzapine and aripiprazole for the indication to treat acute mania in 2012 [23]. Shimazawa et al found that of the 23 psychiatric drugs being all approved in the UK and the USA, only 13 of them were introduced in Japan between September 2000 and July 2011; that none of their development strategies adopted the International Conference on Harmonisation E5 guideline on simultaneous development of drugs on a global scale; and that the median review time (from approval application to approval) of these studied 13 drugs in Japan was 23 months which was considerably longer than those of European Medicines Agency and the US FDA (13.5 and 10.0 months, respectively) [23]. They further lamented that the 10 -13 months difference in review time can not explain the overall 87-and 51-month delay in Japan after approval in the UK or in the USA [23].…”

Section: Discussionmentioning

confidence: 99%

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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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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

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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show abstract

“…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%

“…To date, several studies have compared the review times in Japan to those in the US or Europe Union (EU), or investigated the relationship between review times, components of new drug applications (NDAs), regulatory agencies, and features of pharmaceutical companies in Japan [2,3,5,6,8]. However, to our knowledge, no studies have focused on new drugs that had exceptionally prolonged review times or closely examined the reasons for the prolonged review times in these cases.…”

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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Recent trends for drug lag in clinical development of oncology drugs in Japan: does the oncology drug lag still exist in Japan?

Maeda

Kurokawa

2015

Int J Clin Oncol

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Delays in psychiatric drug development in Japan

Abstract: There remains a large gap between Japan and Western countries, such as the USA and the UK, with regard to access to standard psychiatric drugs, despite several important reforms in the Japanese drug approval system.

Cited by 15 publications

References 18 publications

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

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?

Recent trends for drug lag in clinical development of oncology drugs in Japan: does the oncology drug lag still exist in Japan?

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