Delays in Neurological Drug Development in Japan

Abstract

Objective The lag in the approval and development of neurological drugs between Japan and other countries has been a major issue for patients with neurological diseases. The objective of this study was to analyze the factors contributing to the delay in the launching of neurological drugs in Japan. Methods We analyzed data from Japan and the US for the approval of 36 standard neurological drugs and examined the potential factors that may cause the delay of their launch. Results Of the 36 standard neurological drugs, all of which were approved in the US, only 21 were introduced in Japan from June 1999 to April 2010, whereas the other 15, whose indications were Alzheimer disease, epilepsy, migraine, multiple sclerosis, and Parkinson disease, remained unapproved. The US led Japan in the number of introductions (20 versus 1), with introductions in Japan occurring at a median of 87 months after introductions in the US. Japan's review time of new drug applications (23 months) could not explain this lag. In 15 of the 21 approved drugs, the application data package included overseas data. The mean review time of these 15 drugs was significantly shorter than that of the other 6 drugs without overseas data. The maximum daily doses of 7 of the drugs were higher in the US than in Japan. Conclusion These results show that there is still a large gap between Japan and the US with regard to access to standard neurological drugs, despite several important reforms in the Japanese drug approval system.

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

“…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.…”

Approval gap of pharmacogenomic biomarkers and in vitro companion diagnostics between the United States and Japan

“…Our study confirmed that there is still a substantial approval gap for PGBMs and CDx between Japan and the USA. Approval gaps between the two countries were also observed for neurological and psychiatric drugs . When we focused on oncology, however, there was no approval gap for CDx.…”

Relationship between drug lag and factors associated with clinical trials in Japan

“…In Japan, the number of drugs whose approval was based on data obtained from multiregional clinical trials has increased . In a previous study of neurological drugs, inclusion of overseas data in the application package was associated with a shorter review time in Japan. The drug lag was shorter for drugs with overseas data than for those without, although the difference was not statistically significant.…”

“…To further shorten and eliminate drug lag, it is essential to clarify the associated factors. Several reports are primarily descriptive, and few have analysed the factors related to drug lag in Japan …”