Many drugs that are available in the overseas market have not yet been approved by the Ministry of Health, Labour and Welfare (MHLW) in Japan. A study of the top 100 drugs by sales in 2004 shows a 2.5-year gap between the launch dates in the UK/US and Japan [1]. Of a total of 398 new chemical entities that were approved in either the US, EL) or Japan between 1999 and 2007, 325 (82%) were approved in the US, 314 (79%) in the EU, but only 220 (55%) were approved in Japan [2].This gap, or so-called drug lag, differs among drugs with different therapeutic indications. Drugs against infectious diseases have short lags, whereas those for the treatment of central nervous system diseases have much longer lags [2, 3]. The lag prevents Japanese patients with neurological diseases from accessing these drugs at the same time as patients in other developed nations. Further, it may even delay the progress of clinical research in Japan.
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