35 Japanese Regulations

1

Etienne Labbe ́

Japan is a country of 128 million inhabitants, just a
little larger than California or almost one half of the
United States. It has 270 000 medical practitioners
(2004), and is the second largest drug market in the
world. Economically very attractive, it remains for
Westerners a country difficult to understand and to
communicate with. A strong Dutch, then German,
influence during the eighteenth and nineteenth cen-
turies, respectively, opened Japan to Western med-
icine; it then developed its own techniques to
become internationally recognized as one of the
most advanced countries in the world of biologi-
cal and medical sciences with an average life expec-
tancy of 82 years. However, Japan, land of contrast,
also preserved its traditional therapies of Chinese
origin: herbal medicine (‘kampo’) is still
popular and commonly co-prescribed with ethical
drugs. Such co-prescription seeks to add different
pharmacological effects at low doses without indu-
cing adverse drug reactions (ADRs). It is unethical
for a physician to be responsible for iatrogenic
incidents, and drug safety has long been a priority

to the detriment of efficacy. Japanese regulators

developed the most severe guidelines regarding

drug safety studies in animals and, paradoxically,

clinical development remained, until recently, a

pragmatic approach totally in the hands of medical

doctors, at times hierarchical for clinical drug inves-

tigation. Nowadays, the rules regulating clinical

trials recommend the use of international standards,

and Japan became the leader of several topics at the

International Conference on Harmonization. It has

been a full member since 1991. This chapter will

present the main preclinical and clinical regulations

governing drug development on Japanese territory.

35.1 Organization of Japanese

Health Authorities

General organization

Under the authority of the Minister and the Vice-

Minister, the Ministry ofHealth, Labor, and Welfare

(MHLW or Koseirodosho in Japanese) is responsi-

ble for social security, public health and the promo-

tion of social welfare. For such purposes, the

organization includes (Figure 35.1) the following:

A main body (central offices).

Principles and Practice of Pharmaceutical Medicine, 2nd Edition Edited by L. D. Edwards, A. J. Fletcher, A. W. Fox and P. D. Stonier
#2007 John Wiley & Sons, Ltd ISBN: 978-0-470-09313-9

(^1) All information provided in this chapter comes from official
information published by the MHLW. More details can be
found in good English translation of books published by
Japanese editors.