Delays in psychiatric drug development in Japan

Journal of Clinical Pharmacy and Therapeutics

Volumn 37, Issue 3, 2012, Pages 348-351

  Shimazawa, R ^a   Kusumi, I ^b   Ikeda, M ^a  

^a NAGASAKI UNIVERSITY   (Japan)

^b HOKKAIDO UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

Author keywords

antidepressants; atypical antipsychotics; clozapine; controlled clinical trial; Japanese patients; safety based drug withdrawals

Indexed keywords

ACAMPROSATE; AMFEBUTAMONE; ARIPIPRAZOLE; ATOMOXETINE; BUSPIRONE; CITALOPRAM; CLOZAPINE; DULOXETINE; ESCITALOPRAM; FLUOXETINE; METHYLPHENIDATE; MIRTAZAPINE; MODAFINIL; OLANZAPINE; OXYBATE SODIUM; PALIPERIDONE; PAROXETINE; PSYCHOTROPIC AGENT; QUETIAPINE; SERTRALINE; VENLAFAXINE; ZALEPLON; ZIPRASIDONE; ZOLPIDEM;

ALCOHOLISM; ANXIETY DISORDER; ARTICLE; ATTENTION DEFICIT DISORDER; COMPARATIVE STUDY; DRUG APPROVAL; FOOD AND DRUG ADMINISTRATION; HUMAN; INSOMNIA; JAPAN; MAJOR DEPRESSION; NARCOLEPSY; PSYCHIATRIC TREATMENT; SCHIZOPHRENIA; UNITED KINGDOM; UNITED STATES;

DRUG APPROVAL; DRUGS, INVESTIGATIONAL; GREAT BRITAIN; GUIDELINES AS TOPIC; HEALTH CARE REFORM; HEALTH PRIORITIES; HUMANS; JAPAN; NEUROTRANSMITTER AGENTS; PSYCHOTROPIC DRUGS; TIME FACTORS; UNITED STATES;

EID: 84861332577     PISSN: 02694727     EISSN: 13652710     Source Type: Journal    
DOI: 10.1111/j.1365-2710.2011.01311.x     Document Type: Article

References (28)

1. Berger D, Fukunishi I,. Psychiatric drug development in Japan. Science 1996; 273, 318-319.
2. Fujiwara Y,. MD reviewers' role in the new anticancer drug approval process in the newly established Japanese regulatory agency, PMDEC (Pharmaceuticals and Medical Devices Evaluation Center). Jpn J Clin Oncol 1998; 28, 653-656.
3. Fujiwara Y, Kobayashi K,. Oncology drug clinical development and approval in Japan: the role of the pharmaceuticals and medical devices evaluation center (PMDEC). Crit Rev Oncol Hematol 2002; 42, 145-155.
4. Hirai Y, Kinoshita H, Kusama M, Yasuda K, Sugiyama Y, Ono S,. Delays in new drug applications in Japan and industrial R&D strategies. Clin Pharmacol Ther 2010; 87, 212-218.
5. Tsuji K, Tsutani K,. Approval of new drugs 1999-2007: comparison of the US, the EU and Japan situations. J Clin Pharm Ther 2010; 35, 289-301.
6. American Psychiatric Association. APA practice guidelines. Available at: (accessed 25 August 2011).
7. National Institute for Health and Clinical Excellence. Clinical guidelines. Mental health and behavioural conditions. Available at: (accessed 25 August 2011)
8. Japanese approval data. Available at: ? (accessed 25 August 2011).
9. Drugs@FDA. Available at: (accessed 25 August 2011).
10. Electronic Medicines Compendium. Available at: (accessed 25 August 2011).
11. Yasuda K, Ono S,. New drug development times in Japan. Time of clinical development and approval (Japanese). Office of Pharmaceutical Industry Research (OPIR) Research Paper 2008, No.42.
12. Brunoni AR, Tadini L, Fregni F,. Changes in clinical trials methodology over time: a systematic review of six decades of research in psychopharmacology. PLoS One 2010; 5, e9479.
13. Tufts Center for the Study of Drug Development. Rising protocol complexity, execution burden varies widely by phase and therapeutic areas. Tufts CSDD Impact Report 2010, No.3.
14. Okada F, Sasa H, Otani K, Kaneko S, Fukushima Y, Nomura K,. Buspirone: really non-effective in Japanese patients with anxiety neurosis. Hum Psychopharmacol 1993; 8, 371-372.
15. Kirsch I, Deacon BJ, Huedo-Medina TB, Scoboria A, Moore TJ, Johnson BT, Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. PLoS Med 2008; 5, e45.
16. Balant LP, Balant-Gorgia EA, Cultural differences: implications on drug therapy and global drug development. Int J Clin Pharmacol Ther 2000; 38, 47-52.
17. Arnold FL, Kusama M, Ono S, Exploring differences in drug doses between Japan and Western countries. Clin Pharmacol Ther 2010; 87, 714-720.
18. Malinowski HJ, Westelinck A, Sato J, Ong T, Same drug, different dosing: differences in dosing for drugs approved in the United States, Europe, and Japan. J Clin Pharmacol 2008; 48, 900-908.
19. Shimazawa R, Ando Y, Hidaka S, Saito K, Toyoshima S, Kobayashi F, Development of triptans in Japan: bridging strategy based on the ICH-E5 guideline. J Health Sci 2006; 52, 443-449.
20. Uyama Y, Shibata T, Nagai N, Hanaoka H, Toyoshima S, Mori K, Successful bridging strategy based on ICH E5 guideline for drugs approved in Japan. Clin Pharmacol Ther 2005; 78, 102-113.
21. Tanaka M, Nagata T, Characterization of clinical data packages using foreign data in new drug applications in Japan. Clin Pharmacol Ther 2008; 84, 340-346.
22. Ministry of Health and Welfare. Section 3, Promoting Safety Measures for Pharmaceuticals. Chapter 6, Efforts for Protecting Health and Safety and Improvement of Living Environment. White Paper. Annual Report on Health and Welfare. 1998-1999 Social Security and National Life. Available at: (accessed 25 August 2011).
23. Okuda H, Ogura K, Kato A, Takubo H, Watabe T,. A possible mechanism of eighteen patient deaths caused by interactions of sorivudine, a new antiviral drug, with oral 5-fluorouracil prodrugs. J Pharmacol Exp Ther 1998; 287, 791-799.
24. Ross JS, Madigan D, Hill KP, Egilman DS, Wang Y, Krumholz HM,. Pooled analysis of rofecoxib placebo-controlled clinical trial data: lessons for postmarket pharmaceutical safety surveillance. Arch Intern Med 2009; 169, 1976-1985.
25. Schneeweiss S, Patrick AR, Solomon DH, et al. Comparative safety of antidepressant agents for children and adolescents regarding suicidal acts. Pediatrics 2010; 125, 876-888.
26. Dorsey ER, Rabbani A, Gallagher SA, Conti RM, Alexander GC,. Impact of FDA black box advisory on antipsychotic medication use. Arch Intern Med 2010; 170, 96-103.
27. Daniels CE, Wertheimer AI,. Therapeutic significance of the drug lag. Med Care 1980; 18, 754-765.
28. OECD Health Data 2011. Available at: (accessed 25 August 2011).