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What is known and objective The provision of pharmacogenomic information in drug package inserts ( PIs) has become more common in recent years. The content of PIs can be tailored to meet specific requirements of the target populations. Our objective was to identify, assess and report on differences in pharmacogenomic information in PIs from the United States ( USA), the United Kingdom ( UK) and Japan. Methods Package inserts were obtained from the US Food and Drug Administration ( FDA) Table of Pharmacogenomic Biomarkers in Drug Labels on 1 October 2012. Corresponding PIs were obtained concurrently from Japan and the UK. We compared the pharmacogenomic information included, where the information was located, the therapeutic class of the drug, the type and purpose of the biomarker and the initial US approval year. Results and discussion One hundred eighteen PIs were included in the FDA table. Of the 118 PIs, 29 provided information on drug targets, 69 on metabolizing enzymes and 20 on other aspects. Genomic biomarkers were described in 71 PIs from the UK and 44 from Japan. Consistency in labelling across the three jurisdictions was greater in the 'Indications' section of the PIs than that in the 'Precautions' section. There appears to be greater concordance across countries for the biomarker information in the ' Indications' sections ( UK 65% and Japan 48% relative to the US information) than that in the ' Precautions' sections ( UK 41% and Japan 17%). What is new and conclusion There are substantial differences in the pharmacogenomic information included in PIs from the USA, the UK and Japan. The differences varied according to the PI sections, and type and purpose of the biomarkers. The differences appeared to vary according to the strength of the evidence supporting use of the biomarkers. Further analyses are necessary to determine the causes of these differences. [ABSTRACT FROM AUTHOR]

What is known and Objective: The lag in the approval and development of psychiatric drugs between Japan and other countries has been a major issue both for patients with psychiatric diseases and for psychiatrists. The objective of this study was to analyse factors contributing to delays in launching new psychiatric drugs in Japan. Methods: We analysed data from Japan, the USA, and the UK for the approval of 23 standard psychiatric drugs and examined potential factors that might have contributed the delay of their launch. Results: Of the 23 standard psychiatric drugs, all of which were approved in the USA and the UK, only 13 were introduced in Japan between September 2000 and July 2011. None of their development strategies adopted the ICH E5 guideline on simultaneous development of drugs on a global scale. Twelve of the 13 drugs (not including atomoxetine) were approved in Japan after their approval in the USA and the UK. The median review time (from approval application to approval) of these 13 drugs in Japan was 23 months, which was considerably longer than those of the US Food and Drug Administration and European Medicines Agency (10·0 and 13·5 months, respectively). The 10-13-month difference in review time cannot explain the overall 87- and 51-month delay in Japan after approval in the USA or UK. What is new and Conclusion: 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. [ABSTRACT FROM AUTHOR]