Pharmaceutical Regulatory Science

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Reseach Topics

◆ Regulatory performance

Recent trends in new drug development in Japan such as clinical development time, review time, utilization of foreign clinical data, and pre-NDA consultations are investigated to seek for association with Japanese regulatory performance and global regulatory matters.

◆ Launch delay (“drug lag”)

The issue of launch delay in Japan has drawn increasing attention. The delay can be divided into three lags; namely the lags in the development period, review period, and reimbursement period, which are defined by the time up to filing, from filing to approval, and from approval to price listing, respectively. This research focuses on the lag during the development period and analyzes its factors quantitatively.

◆ Ethnic differences

Ethnic differences in drug evaluation have always been a great issue, especially in interpreting foreign clinical data to Japan. Intrinsic differences in ethnicity have been investigated in many studies, but we focused on the viewpoint of drug developers and reviewers.

◆ Drug safety

Can data show that launch delay, or “drug lag”makes drug use safer through accumulation of safety data in other countries? Furthermore, how should we evaluate the outcome of safety related regulations and the safe use of drugs in clinical settings?

◆ Regulations associated with clinical trials and development (Pharmaceutical Affairs Act, Good Clinical Practice, guidelines)

◆ Constructing database on clinical trials and projects

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