AN OUTLINE OF NIID

Ⅰ．History

Immediately after World War II, Japan suffered from various infectious diseases caused by poor sanitation; infectious diseases such as tuberculosis, typhoid fever, dysentery, diphtheria, Japanese encephalitis, and parasitic infections were rampant, while many other infectious diseases were newly introduced from foreign countries. Under such circumstances, infectious disease control became a high-priority issue for establishing a safe and secure society in the developing nation. In 1947, the National Institute of Health (NIH), which was later renamed as the National Institute of Infectious Diseases, was established as a research institute attached to the Ministry of Health and Welfare for conducting (i) fundamental and applied research on infectious diseases and (ii) national lot release and development of antibiotics and vaccines. In 1892, the Institute for Infectious Disease was founded as a private institute in attached to the Hygiene Society of Japan (Dr. Shibasaburo Kitasato was the founding dean). The institute was then supervised by the Ministry of Home Affairs to enable its transition into an Imperial Institute of Infectious Disease, which was later transferred to the Ministry of Education and f inally incorporated into the Tokyo Imperial University as the Institute for Infectious Disease (IID) in 1914. Despite the frequent change of its name and jurisdiction, the institute had consistently played a central role in infectious disease research in our country. Half of the faculty members of IID were recruited for the establishment of NIH. The new institute initially included 3 departments (research department, quality control department, and pilot production department) and an administration section, which shared the facilities with IID. In 1950s, to comply with the organizational regulation of the Ministry of Health and Welfare, NIH was expanded to 12 research departments, including bacteriology, virology/rickettsiology, tuberculosis, sero-immunology, and antibacterial substances. In 1955, NIH moved to the site of closed Naval Staff College, Kamiosaki, Shinagawa-ku, Tokyo (Shinagawa Labora-tories). Meanwhile, IID, which remained and devel-oped independently at the original site, was reorganized as the Institute of Medical Science of the University of Tokyo in 1967. To cope with the large-scale epidemic of poliomyelitis, occurring in 1958, new facilities for test production and national lot release of poliomyelitis vaccines were urgently needed, and laboratories for quality control of vaccines were established in Musashi Murayama-shi in 1961 (Murayama Branch Laboratories). Thereafter, the Central Virus Diagnostic Laboratory and the Department of Measles Virus were established within the Murayama Branch Laboratories in 1963 and 1965, respectively. In 1981, a maximum containment (physical containment level 4: P4, also known as biosafety level 4: BSL4) laboratory was built as the world’s f ifth P4 facility. However, the facility was not operated as a P4 laboratory based on the request of the local community. In 1978, the Tsukuba Primate Center for Medical Science was established as a branch of the Institute to provide monkeys of homogeneous quality necessary for national lot release and research work. On the basis of the report dealing with the ideal status of the National Institute of Health (August 25, 1984), the whole Institute was reorganized after due consideration on separation of the research section from the quality control section. In 1992, the Shinagawa Laboratories were moved to the present site, Toyama, Sinjuku-ku, Tokyo (Toyama Research Laboratories). The quality control sections (vaccines and blood products) were concentrated to the Murayama Branch Laboratories. In the meanwhile, the AIDS Research Center was established in 1988 to deal with AIDS problems as an emerging infection. In January 1997, the National Institute of Leprosy Research became a Branch of this Institute and started again its functions as the Leprosy Research Center. The Institute was renamed the National Institute of Infectious Diseases (NIID) to show off more clearly the objec-tives of its establishment in April of the same year. At the same time, the Department of Epidemiology was reorganized into the Infectious Disease Surveillance Center to collect all the information of incidents of in-fectious diseases in the same place for enabling rapid measures. The National Institute of Infectious disease has been reorganized one part of the organization since April 2002. The reason is to strengthen study system, and to promote research studies and its substantiality. This object has been guided by the Ministry of Health, Labour and Welfare as consistency of important point preparation and rebuilding of research institute on the basis of general promotion of public welfare scietif ic research for 21st century. Laboratories of Cariology and Periodontology of the Department of Oral Science in NIID has been integrated into the National Institute of Public Health. The Bacteriology and Virology Laboratories in the National Institute of Public health has been integrated into the Infectious Disease Surveillance Center in NIID. The Department of Biomedical Food Research has been transferred to the National Institute of Health Sciences. In April 2005, the Division of Genetic Resources, the Tsukuba Primate Center for Medical Science and the Laboratory of Animal Models of the Department of Veterinary Science have moved to National Institute of Biomedical Innovation. In October 2005, the Division of Molecular Genetics has been reorganized into the Pathogen Genomics Center to conduct extensive molecular research on genomes of pathogenic viruses and bacteria in humans. In April 2007, the Division of Quality Assurance was founded to assure the reliability of national lot release on biological products and antibiotics, and to manage the standard materials for testing. In April 2009, the Inf luenza Virus Research Center was founded to expand and promote research activities related to the inf luenza virus. Accordingly, the Depart-ment of Virology III was redef ined as a department responsible for research on respiratory viral diseases other than inf luenza. Moreover, in the Leprosy Research Center, the Departments of Microbiology and Bioregulation were expanded and integrated into a single department; the Department of Infection Control. It will develop eff icient system for conducting fundamental and applied leprosy research and mycobacteriology. In April 2013, the Department of Chemotherapy and Mycosis was renamed the Department of Mycology in order to strengthen mycological studies. The Infectious Disease Surveillance Center was renamed the Infectious Diseases Surveillance Center, to intensify epidemiological functions. In April 2014, the Division of Quality Assurance and the Division of Radiological Protection and Biology were integrated into a single department; the Department of Quality Assurance and Radiological Protection, consisting of Laboratory of Quality Assurance and Laboratory of Radiological Production. This union is accompanied by introduction of review of summary protocols in October 2012 and reinforcement of international cooperation regarding quality assurance of biological products. In August 2015, the BSL4 facility in Murayama Branch was designated by the Minister of Health, Labour and Welfare as the f irst BSL4 facility in Japan to possess class 1 pathogens under the Infectious Diseases Control Law. In April 2017, the Antimicrobial Resistance Research Center (AMR-RC) was established with the aim to strengthen Japan Nosocomial Infection Surveillance (JANIS) and function as a comprehensive AMR think tank. Accordingly, the Department of Bacteriology II transferred research functions for nosocomial infectious diseases and antimicrobial resistance and quality assurance functions of antibiotics to AMR-RC. Hereafter the Department of Bacteriology II specialized in respiratory bacterial infectious diseases and toxigenic bacterial infectious diseases. In April 2018, the 8th laboratory was established in addition to existing seven laboratories in AMR-RC. In July 2019, NIID received a designation and permission from the Minister of Health, Labour and Welfare to import class 1 pathogens from overseas institutes under the Infectious Diseases Control Law. In September, NIID imported and possessed those pathogens in the BSL-4 facility in Murayama Branch. In April 2020, the Division of Biosafety Control and Research and the Division of Experimental Animal Research were integrated as the Management Department of Biosafety and Laboratory Animal Research. In addition, the Center for Emergency Preparedness and Response was established to play a central role in the emergency management of infectious disease events by delineating the off ices responsible for crisis management, pathogen diagnosis, and laboratory trainings from the Infectious Disease Surveillance Center. The Division of Information System, which is responsible for the construction, operation and management of the institute-wide network system, was added to the Department of Quality Assurance, Radiation Safety, and Information System (formerly the Department of Quality Assurance and Radiological Protection). In April 2021, the following organizational restructuring was carried out in order to strengthen the crisis management system in light of the worldwide spread of COVID-19. To strengthen and focus on research on acute respiratory viral infectious diseases including inf luenza, the Inf luenza Virus Research Center was reorganized as Research Center for Inf luenza and Respiratory Viruses. The Department of Immunology was reorganized as the Research Center for Drug and Vaccine Development for promoting research and development. In addition to the three existing laboratories in the Department of Virology III, some of the functions of the fourth laboratory were transferred to Research Center for Inf luenza and Respiratory Viruses, and the newly established fourth and f ifth laboratories were added to strengthen the laboratory functions for lot release tests of vaccines. In the Management Department of Biosafety and Laboratory Animal Research (the present name is “The Management Department of Biosafety, Laboratory Animal, and Pathogen Bank”), the existing two laboratories were divided into four laboratories, and the f ifth through seventh laboratories responsible for the pathogen bank affairs were established. Planning and Coordination became the Research Planning and Coordination Center in April 2021 so that the functions of inter-sectional coordination within the NIID as well as collaboration with other research institutions could be strengthened. The new Center has two off ices. The Center for Surveillance, Immunization, and Epidemiologic Research established eight new units in addition to the existing six units. The Center for Emergency Preparedness and Response established another three off ices in addition to the existing f ive off ices. The Center for Field Epidemic Intelligence, Research, and Professional Development (CFEIR) was established in April 2021 for strengthening f ield epidemiological investigation in collaboration with local governments and the Ministry of Health, Labour and Welfare, and for conducting both public health research and training in f ield epidemiology. In April 2022, the department of Safety Research on Blood and Biological Products was reorganized into the Research Center for Biological Products in the Next Generation and was established another laboratory in addition to the existing four laboratories. In Department of Veterinary Science, a new fourth laboratory was established in addition to the current three laboratories. In Pathogen Genomics Center, a new fourth laboratory was established in addition to the current three laboratories. In April 2024, the department of quality assurance, radiation safety, and information system was reorganized into the Center for Quality Management Systems, management department of biosafety, laboratory animal, and pathogen bank was reorganaized into the Research Center for Biosafety, Laboratory Animal and Pathogen Bank. In April 2025, NIID was merged with the National Center for Global Health and Medicine (NCGM) to form a new Institute, Japan Institute for Health Security (JIHS), whose vision is to be a World-leading Integrated Infectious Disease Science Center. As a world-class comprehensive infectious disease science center, JIHS is supposed to address various diseases and health crises, including infectious diseases, and the research institute is expected to play an important role as NIID. Furthermore, with the establishment of the new organization, the comprehensive evaluation function for national lot release of vaccines, blood products, and other items, long performed by NIID, was transferred from NIID to an independent department, the Department of Quality Control, established within JIHS. However, while maintaining the quality testing function for pharmaceuticals related to infectious disease countermeasures and contributing to ensuring the quality of these pharmaceuticals, the Institute is expected to continue its role that has been traditionally held within the international framework led by the WHO as Japan's National Control Laboratory.

Ⅱ．Functions

JIHS's mission is to “contribute the creation of a resilient and secure society through the implementation of R&D on infectious diseases and other diseases, as well as the provision of medical care.” To fulf ill this mission, four functions are required: ①Disease Intelligence: Information collection, analysis and risk assessment; ②Research, Development and Innovation (R&D); ③ Comprehensive Medical Care; and ④Human Resource Development, International Cooperation. NIID is expected to play a central role in the ①Disease Intelligence and ② R&D on infectious diseases and to be largely involved in ④Human Resource Development, International Cooperation. All functions cultivated by this institute to date―infectious disease research, epidemiological and public health response, quality control of biological products, safety management, international cooperation, and human resource development―are critical. These functions―including [1] research activities, [2] reference services for infectious diseases, [3] surveillance of infectious diseases, [4] national control tests and other tests, [5] international cooperation, [6] training programs, and [7] outreach activities―are to be carried out while being further strengthened and developed.

（1）Basic and applied research on infectious diseases

Basic and applied research projects on infectious and other intractable diseases associated with the immune systems are under way. Particularly, molecular biological analyses of the etiological agents and immunological and pathological analyses of infectious diseases as well as development and application of diagnostic methods, therapeutics, and vaccines for emerging and re-emerging infectious diseases and other traditional diseases are the main projects. Research on development of the next generation vaccines including mucosal and nucleotide vaccines are being worked out actively. In recent years, the environment surrounding infectious diseases has been changing dramatically; the increase in inbound tourists accompanied with development of international transport networks, the inf luence of criminal changes and global warming, and a glowing number of zoonosis and infections caused by antimicrobial resistance microbes are given as important issues. Thus, NIID has been developing multiple strategies to address emerging infectious disease threats in a wide range.

（2）Reference services for infectious diseases

The reference services include all that are necessary for ensuring the assay systems for infectious diseases. In concrete terms, the services involve storing and supplying pathogenic agents (pathogenic microorganisms and their products, parasites, and vector insects), standardizing the reagents, preparing and supplying reference materials needed for diagnosis and surveillance of infectious diseases, educating professional technicians, and information exchange. To carry on infectious disease reference services, a reference committee was organized, and in cooperation with prefectural public health institutes, collaborative activities are carried out to control infectious diseases. After JIHS establishment, collaboration with regional public health institutes on scientif ic and technical cooperation regarding infectious diseases and contribution to human resource development including trainings are to be further strengthened and enhanced.

（3）Infectious disease surveillance program, and collection, analysis, and feedback and distribution of information on infectious diseases

As a national project of surveillance, This Institute collects reports of detection of infectious agents from prefectural public health institutes and those of incidents of infectious diseases from sentinel clinics in the whole country, based on the Infectious Diseases Control Law. This information is accessible to the public, as weekly (IDWR) and monthly (IASR) reports. Starting in April 2025, a new acute respiratory infection (ARI) surveillance system was launched. In the case of occurrence of an epidemic or outbreak of an infectious disease, epidemiological investigations will be carried out and the information exchanged with infectious dis ease surveillance organizations in other countries. Field Epidemiology Training Program, Japan (FETP-J) provides a training course of f ield epidemiologists, who enable to conduct effective epidemiological investigations. To make these activities more eff icient, the Infectious Disease Surveillance Center organized in April 1997, and was renamed the Infectious Diseases Surveillance Center, to intensify epidemiological functions in April, 2013. This Center is responsible for surveillance on all of targeted diseases by Infectious Disease Control Law. In April 2021, FETP also became independent as The Center for Field Epidemic Intelligence, Research, and Professional Development. Since then, it has continued to strengthen its f ield epidemiology research capabilities and its FETP network both domestically and internationally.

（4）National lot release and other tests, and research on quality control of biological products and antibiotics

(1) NIID conduct biological testing and trial production of biological agents, antimicrobial substances and their preparations, disinfectants, insecticides, and rodenticides for prevention, treatment, and diagnosis, as well as manufacture reference standards required for the biological testing of these pharmaceuticals and quasi-drugs. Besides, research on quality control of biological products and antibiotics such as development of new test methods and improvement of test methods are being conducted based on the latest information and knowledge.
(2) In addition to administratively required tests, tests requested by clients are being carried out for biological products and antibiotics.

（5）International cooperation activities

To prepare for emerging and re-emerging infectious diseases as global threats to the public health, NIID engages in various international activities including dissemination of information on a global scale, contribution on research collaboration and technology transfer while cooperating with World Health Organization (WHO) and other foreign research institutes. Since 2003, NIID has exchanged the Memorandum of Cooperations (MOCs) on research collaboration with its counterparts e.g. China, South Korea, Indonesia, Viet Nam, India, Mongolia, Thailand, Taiwan, etc. Additionally, NIID annually organizes multilateral international meetings such as Japan China-Korea Forum on Infectious Diseases Control and Prevention, and properly advances bilateral collaborative research activities.

WHO-designated centres and WHO reference laboratories

• Japanese Encephalitis Global Specialized Laboratory (Department of Virology I)
• WHO Collaborating Centre for Virus Reference and Research (Enterovirus) (Department of Virology II)
• Polio Global Specialized Laboratory (Department of Virology II)
• Polio Regional Reference Laboratory (Department of Virology II)
• National Polio Laboratory (Department of Virology II )
• Measles and Rubella Global Specialized Laboratory (Department of Respiratory Viruses, Department of Bioinformatics and Integrative Omics)
• WHO Collaborating Centre for Reference and Research on Inf luenza (Inf luenza Research Center)
• WHO National Inf luenza Centre (Inf luenza Research Center)
• H5 Inf luenza Reference Laboratory (Inf luenza Research Center)
• Essential Regulatory Laboratory (Inf luenza Research Center)
• Collaborating Centre on Standardization and Evaluation of Biologicals (Center for Quality Management Systems)
• Human Papillomavirus Laboratory Network Western Pacif ic Regional Reference Laboratory (Pathogen Genomics Center)
• WHO Collaborating Centre for AMR Surveillance and Research (Antimicrobial Resistance Research Center)
• Reference Laboratory for WHO Global Surveillance of Drug Resistance in Leprosy (Leprosy Research Center)
• WHO Coronavirus Network (CoViNet) Reference Laboratory (Inf luenza Research Center, Department of Respiratory Viruses

（6）Training programs

Various kinds of group and individual technical trainings on AIDS, poliomyelitis, and leprosy are being given to foreign trainees. In addition, NIID plans and conducts training programs for the workers from domestic research organizations including public health institutes. The institute also plans and conducts training programs for personnel at domestic research institutions, public health agencies, and other organizations. These programs aim to disseminate knowledge on infectious disease crisis management and to impart the knowledge and practical skills necessary for testing and diagnosis. Each year, the institute trains over 2,000 participants in total, striving to develop human resources

（7）Public communication

The Institute facilitates outreach activities such as NIID Open Day at both Toyama and Murayama Research Laboratories that engage the public in our missions and research goals. Additionally, NIID holds annual public lectures aimed at the general public to explain infectious diseases in an easy-to-understand manner. Videos of past lectures are available on YouTube as the “NIID Channel.”