Event Information

Time: March 7, 2017 (Tuesday)

Place: TRPMA Conference Room

TRPMA and Linical jointly organized a forum on the medical regulatory trends in Japan. Mr Kazu Hatano (the Present of Linical), Mr Masaya Miyazaki (Vice CEO of Linical) and Dr Toshiaki Nagafuji (R&D Director of Linical) briefed the audience on the medical regulations, current situations of R&D and clinical trial consultation, the strategy of SAKIGAKE and new drug pricing mechanism in Japan.

Dr Nagafuji expressed that the PMDA has largely increased its review capacity and established the R&D strategy consultation mechanism in order to improve the review efficiency. The average time required for NDA review was reduced to 253 days in 2015, more efficient than the US FDA (351 days). Linical also introduced the new drug pricing mechanism in Japan, including cost pricing method. Some European drug companies hence prefer to launch new drugs in Japan because of better prices.

Japan is one of the five major pharmaceutical markets in the world. However, most Taiwanese manufacturers give the Japanese market a lower priority due to high regulatory barriers. Communications and forums like this one will help new drug developers in Taiwan to push back the boundaries and reach out to collaboration partners in Japan. The TRPMA will continue to run a series of forums to promote the collaboration between Taiwan and Japan.