[Press Release] JETRO Healthcare Webinar: Regulation, Reform, and & Subsidy Programs

May 04, 2016


APRIL 28, 2016, SAN FRANCISCO, CA - JETRO San Francisco launched their new monthly webinar series featuring foreign business opportunities in Japan’s domestic market. The first webinar in the series focused on recent regulation changes to Japan’s healthcare industry, particularly in the areas of pharmaceutical and regenerative medicine manufacturing.


Event speaker Yoshiaki Tojo, Chief Executive Director for JETRO San Francisco, highlighted three key areas for foreign companies to focus on:


1.       Japan’s changing demographics both as an individual country and as a player in the Asia-Pacific region

2.       Regulatory reforms that have opened Japan up to faster drug review and approval rates

3.       New incentive programs that have made opening a manufacturing site in Japan easier than ever for foreign medical manufacturers


Japan’s Changing Demographics


Japan is one of the world’s oldest countries, with a median age of 46.1. Japan also holds the crown for longest life-expectancy at birth, with the average Japanese citizen living to 84 years of age (citizens of the United States live on average until 79). Current estimates expect nearly 40% of Japan’s population will be over the age of 60 by 2060.


Mr. Tojo noted that Japan may have one of the oldest populations, but the country’s situation is certainly not a unique one— at least, not for long. Japan’s neighbors (Hong Kong, China, Singapore, and Thailand) have aging populations of their own, although many of them will not experience a surge in senior care solutions for another several years.


The current situation makes Japan a perfect “pioneer” country for companies developing innovative senior care solutions. It also allows the country to serve as an excellent doorway to the Asia-Pacific market for drug and device manufacturers.


Regulatory Reform That’s Changing Japan’s Drug Review & Approval Process


Japan’s demographics are aided by the country’s strong National Healthcare Insurance (NHI) program, which provides medical coverage for all citizens who are not covered by an employer-based healthcare insurance policy. The NHI covers 70-90% of medical expenditures made through allied partners. This reimbursement policy allows Japanese citizens to seek quality healthcare solutions that meet their needs without stressing about bottom-line costs. NHI is continually expanding their list of reimbursed treatments, making it easier for clients to seek new health treatments as they become available on the market.


In addition to a strong national healthcare program, Japan has also expedited its drug review and approval process. The Pharmaceuticals and Medical Devices Agency (PMDA), the Japan equivalent of the Food and Drug Administration (FDA), has established a review process that allows them to approve new active substances in less than a year. It takes approximately 306 days for the PMDA to approve new active substances. By contrast, it takes 343 days to receive approval from the FDA and 418 from the European Medicines Agency (EMA). 


The PMDA has also established an expedited approval process for regenerative medicine. New legal framework allows for provisional approval of regenerative medical products before phase III of clinical trials, making it possible for bio-medical startups to implement new treatments at a faster rate.


These new policies have seen a number of new medical startups and partnerships emerge as a result. Nikon and Lonza recently partnered to establish new medical facilities in the Tokyo and Yokohama area for the purpose of developing new cell and gene therapy products. Chugai and Athersys partnered to commercialization of MultiStem® cell therapy for ischemic stroke in Japan.


Other individual industry disruptors include Quantum Biosystems, Cyfuse Biomedical K.K., and SanBio.


New Incentive Programs for Regenerative Medicine Manufacturers


Japan’s changing drug approval policies are not the only benefit for foreign pharmaceutical and regenerative medicine manufacturers. JETRO recently developed a new subsidy program for companies in the regenerative medicine industry. This subsidy program supports foreign companies seeking to establish innovation centers, experimental studies, or feasibility studies (F/S) in Japan with the assistance of Japanese companies or other local entities.


Over 1 billion JPY has been allotted towards this subsidy program, with subsidies awarded on a first-come, first-serve basis. JETRO provides support to companies interested in applying to the program. To learn more about the application process, please visit our Subsidy Program for Global Innovation Centers page.


The program closed with audience questions and a highlight for the next webinar in the series, which will take a closer look at Japan’s energy industry.


To access the webinar recording or receive a copy of the presentation, please contact the JETRO San Francisco office through our Contact Us page.