P333: Overview of the Latest Japanese Regulation Reforms and Acceleration in Clinical Development of Orphan and Innovative Drugs
Poster Presenter
Motoki Fujii
Executive Professional of Regulatory Affairs
EPS Group Japan
Objectives
Japan is the third largest pharmaceutical market in the world but may be considered a unique challenging country to include in drug development, especially given its regulatory system. Learn about the clinical development regulations that you need to be aware of when developing drugs in Japan.
Method
Japan and USA regulations were compared using the latest notifications and review of recent periods of clinical development in both countries were used to identify and understand the differences between Japan and the USA.
Results
There are no significant differences between Japan and the USA in terms of the systems to promote drug development, such as types of consultations with authorities, including pre-IND meetings, priority review system, or orphan drug designation system. According to a November 2024 research paper by the Office of Pharmaceutical Industry Research, the median NDA review period of Japan’s PMDA and the US FDA are similar. Since 2011, the median review time has been around 10 to 11 months in both countries.
In recent years, there has been a movement in Japan to promote the introduction of drugs into the Japanese market by using overseas data, relaxing the requirement for Japanese Phase 1 trials when participating in Multiregional Clinical Trials, and not requiring Japanese data for approval applications of drugs for rare diseases. In addition, although certain conditions are required, the acceptance of NDA documents written entirely in English has also begun. Several relevant notifications will be explained.
Furthermore, in November of 2024, PMDA opened an office in Washington DC and began providing free explanations about Japanese regulations to venture companies. The Washington DC PMDA office also provides other services including free early general development consultation to support companies’ expansion into Japan.
Conclusion
Thanks to the ongoing efforts of the Japanese authorities, the NDA review period is now equal to that of the United States. However, a major problem in Japan is the so-called drug lag and loss. This refers to a drug being approved overseas but not developed in Japan, or a drug being introduced in Japan taking a long time, and is recognized as an issue that must be resolved immediately. To solve this problem, the Ministry of Health, Labor and Welfare has established a committee of experts to consider the state of pharmaceutical regulations. As a result, several notifications have been issued, and regulations on the necessity of Japanese Phase 1 trial data and application data for rare disease drugs have been gradually relaxed. Therefore, we expect overseas venture companies with new drugs and new modalities to actively approach Japan, and we believe that an environment that enables this, such as a drug discovery ecosystem, is being developed as well as there being a lot of room in the market.
