About ENSEMBLExJ Project
The ENSEMBLExJ Project supports Global BioTech companies, including emerging biopharma companies and biotech ventures, that do not have a drug development base in Japan. Through consulting and support for drug development and business expansion in Japan, the project aims to help eliminate drug lag and drug loss in the Japanese market.
While promising new medicines are being developed around the world, Japan faces growing social challenges related to “drug lag,” in which it takes time for these medicines to reach patients, and “drug loss,” in which such medicines are not developed in Japan at all.
For Global BioTech companies without a presence in Japan, identifying how to enter the Japanese market, finding suitable partners, and assessing the regulatory and business feasibility of drug development in Japan can present significant barriers. At the same time, however, many misconceptions exist regarding the Japanese market.
Through collaboration among industry, government, and academia, the ENSEMBLExJ Project provides information and opportunities to deepen understanding of the Japanese market and supports the development of networks with key stakeholders. In doing so, the project aims to help bring new treatment options to patients in Japan who need them.
Why develop and commercialize in Japan?
Until now, the Japanese market has often been associated with negative perceptions, such as “complex regulatory systems,” “lengthy development timelines,” and “low drug prices.”
Today, however, the strategic value of incorporating Japan early into global development plans is increasing. This is driven by factors such as earlier inclusion of Japan in global clinical development, faster regulatory review processes, pilot initiatives to accept English-language documents, spillover benefits for expansion across Asia, and pricing incentives for important medicines.
Japan’s drug pricing system
In Japan, the prices of new drugs are set under the public health insurance system, with evaluations taking into account factors such as innovation, clinical usefulness, and rarity.
At the same time, Japan has a system of regular drug price revisions. Therefore, a proper understanding of the drug pricing system is essential when assessing the business feasibility of entering the Japanese market Among these mechanisms, the Price Maintenance Premium, or PMP, is an important consideration when exploring early entry into the Japanese market, as it is designed to recognize the value of innovative new medicines.
A clear understanding of the system, together with early alignment of development strategy and business strategy, can increase the likelihood of success in the Japanese market.
Reasons to incorporate Japan early into development strategy
The Japanese market was once often considered only in the later stages of global development. Today, however, there is growing strategic value in incorporating Japan into development plans from an early stage.
Drug development in Japan offers multifaceted advantages, including the PMDA’s strong review capabilities, the potential use of expedited regulatory pathways, the credibility that comes with obtaining approval in Japan, and opportunities for broader expansion into Asian markets.
Furthermore, by considering Japan from the early stages of development, companies can design a more strategic plan that takes into account the timing of approval, potential business partnerships, and effective use of the patent period.
Advantages of Japanese Approval and Expansion into Asia
PMDA Approval encourages your access to Asian market with regulatory advantages
If JPMDA has approved a drug;
- Philippine FDA : Review time [180d → 45d]. If 2 or more referenced countries have approved, the time can be reduced to [30d]
- Indonesia NADFC : Review time [300d → 120d] by providing PMDA review report.
- Taiwan FDA : Review time [360d →180] if two out of ICH regions (US/EU/JPN) approvals or 120d with all approval.
- Malasia, India, Australia and so on.