The National Institute of Health Sciences(NIHS), which was
established in Tokyo in 1874 as the Tokyo Drug Control
Laboratory (later renamed the Tokyo Institute of Hygienic
Sciences), is now a major organization within the Ministry
of Health, Labour and Welfare (MHLW).It is the oldest
national research institute in Japan and currently consists
of 21 divisions, 5 of which belong to the Biological Safety
Research Center (BSRC).
Initially, the NIHS was principally engaged in the
analysis and qulity inspecion of imported drugs and in the
analysis of chemicals in foodstuffs and drinking water as
well as hot spring water. After the outbreak of World War I
in 1914, research on the manufacturing of essential drugs
became of major significance due to difficulties and in some
cases the cessation of their importation. This paved the way
for Jpapan to establish a modern pharmaceutical industry.
In 1922, the first Experimental Station for Medicinal
Plants, which was established at Kaskabe, began research
involving trial planting and other activities.
In 1938, the Institute was placed under the contol of the
newly launched Ministry of Health and Welfare. In 1946, the
laboratory moved its office from Kanda Izumi-cho to its
current location in Yoga, since when the NIHS has greatly
expanded its facilities, staff and organization. In 1949,
its name was changed to the National Institute of Hygienic
Health Sciences. In the same year, the Osaka Institute of
Hygienic Health Sciences became the Institute's Osaka
In 1978, the Biological Safety Research Center was
established in the NIHS together with a new building and
animal facilities. The Center serves as Japan's leading
safety testing and research organization.
In 1980, the main Experimental Station for Medicinal
Plants was moved from Kasukabe to Tsukuba, where it became
the Tsukuba Experimental Station for Medicinal Plants. While
strengthening its operations, the Station also established a
system for researchers to communicate with other
laboratories in Hokkaido, Izu, Wakayama, and Tanegashima.
Since 1985, various new substances requiring the
evaluation of quality, safety or efficacy have emerged.
These include not only pharmaceuticals in the form of new
drugs and recombinant DNA products, but also medical devices
and their materials, newly developed food products, and
natural additives. New research activities to evaluate their
quality and safety have become necessary.
In 1997, with the reorganization of the requlatory system
for pharmaceuticals and medical devices in Japan, the
Pharmaceuticals and Medical Devices Evaluation Center was
established in the NIHS. This Center is responsible for
pre-marketing evaluation of pharmaceuticals and medical
In 2002, consolidation of food-related fields and other
evolving fields resulted in the reorganization of national
research institutes. This led to the closing of the
Experimental Station for Medicinal Plants in Izu and the
establishment of Division of Cellular and Gene Therapy
Products, the Division of Biomedical Food Research, and the
Division of Medical Safety Science in the NIHS.
In 2004, the Osaka Branch was reorganized to conduct
research that will provide the basis for developing
epoch-making medicinal products through the application of
genome science, protein science and other evolving sciences.
As part of this reorganization, the Branch was relocated to
Ibaraki Ctiy in Osaka Prefecture.
Meanwhile, unification of the approval and examination
system of pharmaceuticals resulted in the Pharmaceuticals
and Medical Devices Evaluation Center merging with the
Pharmaceuticals and Medical Devices Agency.
In 2005, the National Institute of Biomedical Innovation
was established to conduct research on converting the fruits
of basic research into pharmaceutical and medical device
development as well as supply research resources for
supporting such development in Japan. Jurisdiction over the
Call Bank Division, Osaka Branch, and Experimental Stations
for Medicinal Plants (Hokkaido, Tsukuba, Wakayama, and
Tanegashima) was transferred to this Institute.
NIHS is a key organization engaged in testing and research
from an international perspective, and also provides
international cooperation in relevant fields.