Event Information

Time：November 25, 2015 (Wednesday)
Place：TRPMA Conference Room

TRPMA invited Dr Isao Sasaki, Director of the Asian RA Group of the Astellas Pharma in Japan, to deliver a special speech on the drug regulation system and IND/NDA process in Japan and to share a Japanese pharma company’s experiences in entering the global market.

First of all, Dr Sasaki introduced the two major pharmaceutical regulatory agencies in Japan: MHLW and PMDA. The MHLW (Ministry of Health, Labour and Welfare) is responsible for establishing regulations and issuing market authorization. The PMDA is in charge of reviewing the applications of drugs and medical devices, as well as carrying out GCP and GMP inspections. Dr Sasaki explained the evolvement of the Pharmaceutical Affairs Law into various regulations of medical products and devices in November 2014. He also introduced the clinical trial review and drug review processes in Japan. There is a fast track review mechanism “Sakigake Strategy”. Drugs qualified for the fast track review mechanism, for example drugs for severe conditions or first in the world treatment, will enjoy a streamlined procedure to make them accessible to patients as soon as possible.

Dr Sasaki talked about the Japanese new drug industry’s global development strategies. In Japan, drug companies try to expand their market by participating in multi-nation and multi-center clinical trials. He mentioned the importance of Good Submission Practice (GSubP). Drug companies can refer to the GSubP Guidelines issued by the APAC to improve the quality of their submission.

Finally, Dr Sasaki suggested that drug companies should make good use of the advisory services provided by the PMDA and communicate with the regulatory agencies as early as possible so as to keep the product development strategies on the right track.