An external bureau: the Social Insurance
Agency.
An advisory body: the Pharmaceutical Affairs
and Food Sanitation Council (PAFSC), involved
in New Drug Application (NDA) review.
The main body of the MHLW is divided into three
branches:
1.The core administration, which consists of the
Secretariat (including the Statistics and Infor-
mation Department), and 11 bureaus, which are
as follows: Health Policy Bureau; Health Ser-
vice Bureau; Social Welfare and War Victim’s
Relief Bureau; Health and Welfare for Elderly
Bureau; Equal Employment, Children and
Families Bureau; Insurance Bureau; Pension
Bureau; the Pharmaceutical and Food Safety
Bureau (PFSB), which plays a major part in
drug regulations; and the Director-General for
Policy Planning and Evaluation. Around 2000
officials work full-time in the central offices.
2.Regional branches. Each prefectural govern-
ment (47 prefectures) offers a local branch of
the Health Authorities and Labour Bureaus: the
Regional Medical and Pharmaceutical Affairs
offices, and the District Narcotics Control
offices. New drug applications are made
through the regional office of the prefecture
where the company is situated.
3.Affiliated institutions. In the present organiza-
tion, national hospitals such as the National
Cancer Center and three affiliated institutions
operate under MHLW supervision:
(a) The National Institute of Health Sciences,
performing tests and research on drugs, food
and chemical substances.
(b) TheNationalInstituteofInfectiousDiseases,
conducting research on pathogenicity, etiol-
ogy, prevention of certain diseases, and tests
and research onvaccines and blood products.
(c) The National Institute of Population and
Social Security Research, training public
health technicians, conducting surveys
related to public health and so on.
More than 50 000 officials are working for the
MHLW general organization.
Pharmaceutical administration
The PFSB, the Health Policy Bureau, with the
assistance of the PAFSC, and the Pharmaceuticals
and Medical Devices Agency (PMDA or Kiko in
Japanese) represent the managing authorities of
Japanese pharmaceutical administration, in charge
of reviewing drug application for approval, reex-
amination or re evaluation.
The PFSB
The PFSB consists of a Secretary General, five
divisions and one office. It ensures safety and
efficacy of drugs, quasi-drugs and medical devices,
editing as well policies regarding blood supplies,
blood products, narcotics and stimulants.
General Affairs Division. This division coordi-
nates all activities of the PFSB, enforces the Phar-
maceutical Affairs Law (PAL), manages questions
related to the PAFSC, and provides guidance and
supervision to the PMDA. Two offices attached to
the Planning Division are as follows:
- The Office of Access to Information, ensuring
publication of information held by administra-
tive organization.
Pharmaceutical Affairs
And Food Sanitation Council
Secretariat and
main bureaus (11)
Affiliated
institutions
MHLW
Regional
branches
External Bureau :
Social Insurance Agency
Figure 35.1 General organization of the Ministry of
Health, Labor, and Welfare
488 CH35 JAPANESE REGULATIONS