MEDICAL DEVICE APPROVAL PROCESS IN JAPAN

摘要

The Ministry of Health, Labor and Welfare (MHLW or Koseirodosho in Japanese) is in charge of the pharmaceutical regulatory affairs in Japan. Formal approvals and licenses are required to marketing drugs in Japan which are obtained from the MHLW. Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has set itself the challenging task of expediting patient access to novel therapies while ensuring these meet international standards of safety, efficacy and quality. One of the biggest hurdles for the government is the “drug lag” problem, whereby many new innovative medicinal drugs do not reach the Japanese market until several years after the United States (US) and Europe (EU). This delay is caused due to the obligation to perform clinical bridging studies in Japan hand since clinical data obtained in non-Japanese trials such as EU and US studies cannot solely be used to obtain market approval in Japan. Japan provides a public medical insurance system, which is carried on as a social insurance system covering all citizens. Through this insurance system, about 30% of the nation’s medical expenses are covered by public funds, and all prices for medicine, including medical compensation for doctors and prices for new drugs are substantially controlled by the Japanese government.