Japan Launches NIH Analogue

Posted 01 April 2015 | By Michael Mezher 

Japan Launches NIH Analogue

Today marks the launch of Japan’s new Agency for Medical Research and Development (AMED), which will take on the role of leading research and development in the country through partnerships between universities and industry.

The agency’s launch is part of a larger restructuring of Japan’s publicly funded research and development sector.


AMED was created following the passage of two acts in 2014, The Act on Promotion of Healthcare Policy and the Act on the Independent Administrative Agency of Japan Agency for Medical Research and Development.

The agency is modeled after US National Institutes of Health (NIH), and has been a topic of discussion in Japan for years. While the agency has been backed by the government and Prime Minister Shinzo Abe, some members of the research community in Japan have criticized the plan to centralize research and development oversight.

Japan currently has a number of different organizations that conduct biomedical research, including the National Hospital Organization (NHO), National Institute of Radiological Science (NIRS) and National Institute of Biomedical Innovation (NIBIO). These and many other research institutes are overseen by three different ministries—Education, Culture, Sports, Science and Technology Ministry; Health, Labor and Welfare Ministry and Economy, Trade and Industry Ministry.

The Japan News reports that AMED will now oversee the ¥140 billion ($1.2 billion) research budget from the three aforementioned ministries, and is launching with approximately 300 staff.

One of the major drivers behind the formation of AMED is to boost Japan’s economic productivity in the healthcare products sector by taking more products from discovery to market. The government hopes that the more vertical management structure will streamline the country’s research and development efforts.

Role of AMED

According to ThePlan for Promotion of Medical Research and Development, AMED will have five expected functions:

  • “Management of medical R&D
  • Data management in clinical research and trials
  • Support for practical applications
  • Support for the development of R&D infrastructure
  • Promoting international strategies”

To support these functions, AMED will have a team of program directors and officers with “abundant experience in basic research, clinical research and trials, and drug discovery and development, thereby ensuring seamless, integrated management of research focused on practical applications from the basic research stage onward.”

Regulatory Spotlight

In formulating its new research and development strategy, the Japanese government has recognized that “collaboration with regulatory authorities [is] essential in order to link R&D to innovation.” The government also declares that regulatory compliance is “vital” to translational research, which is the process of taking findings from basic life science research and translating them into the development of new products and technologies.

The agency will also provide consultation on the development of intellectual property and offer advice on “exit strategies” for products “in partnership with the [Pharmaceuticals and Medical Devices Agency] (PMDA).”

The Plan for Promotion of Medical Research and Development also calls for the government to increase its efforts to “disseminate and enhance regulatory science … in R&D,” which will be done through strengthened partnerships with industry, universities and research institutions.

Research Areas and Benchmarks

Japan has identified nine key research areas that AMED will focus on:

  • drug discovery
  • medical devices
  • translational and clinical research core centers
  • regenerative medicine
  • genomic medicine
  • cancer
  • psychiatric and neurological diseases/disorders
  • emerging/re-emerging infectious diseases
  • rare/intractable diseases

The government has also identified key performance indicators for each area for 2015 and 2020. The indicators reflect the country’s ambition to rapidly increase its productivity in the healthcare sector and reduce its current ¥2.5 trillion ($21 billion) trade deficit for medical products. This is reflected by key performance indicators (KPIs) such as doubling the country’s medical device exports and quintupling number of promising drug seeds the agency supports by 2020.


The Plan for Promotion of Medical Research and Development, KPI Slides, The Japan News

Categories: Regulatory News

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