Principles and Practice of Pharmaceutical Medicine

2. The Office of Drug Induced Damages, which
   supervises the PMDA and the administration of
   work related to ADRs damages.

Evaluation and Licensing Division. This division
surveys and coordinates regulation of production,
research and trade of drugs, quasi-drugs and med-
ical devices. Many other services are provided by
this division: licenses for manufacturing or import
of drug and medical devices, designation of orphan
drugs and medical devices; guidance to the
PMDA; supervision of standards and specifica-
tions for drugs, quasi-drugs and cosmetics; gui-
dance for the Japanese Pharmacopoeia (JP);
Reexamination and reevaluation of drugs and
medical devices.
Safety Division. The responsibility of this divi-
sion is to ensure the safety of drugs, quasi-drugs,
medical devices and cosmetics. The Office of
Appropriate Use of Drugs, attached to this divi-
sion, collects and evaluates information related
to ADRs and promotes the appropriate use of
drugs.
Compliance and Narcotics Division. The role
of the division is to control and inspect, looking for
quality issues, faulty labeling, unlicensed drugs,
quasi-drugs, medical devices and cosmetics. It
gives guidance for advertising, testing, official
certification and good manufacturing practice
(GMP). It supports the enforcement of the Narco-
tics and Psychotropics Control Law, Cannabis
Control Law, Opium Law and Stimulants Control
Law.
Blood and Blood Products Division. This divi-
sion regulates blood collection, proper use of blood
products, and production and distribution of biolo-
gical products.

The Health Policy Bureau

The Health Policy Bureau handles promotion of
R&D, drug, quasi-drugs, medical devices and sani-
tary materials production and distribution policies.
It is divided in two divisions, the Economic Affairs
Division and the Research and Development
Division, both having relationship with the phar-
maceutical industry.

The PAFSC

The PAFSC, an advisory organ of the MHLW,

investigates and discusses important matters

related to pharmaceutical affairs and food sanita-

tion. The PAFSC members are experienced specia-

lists in the field of medicine, pharmacy, biology,

dentistry and veterinary medicine, coming from

universities, public hospitals and research insti-

tutes; there are 55 permanent members and about

400 temporary members, function of the topics to

be discussed. Major subjects treated by the PAFSC

include the following:

Revision of the JP.

Determination of standards for drugs.

Evaluation ofthe relevance ofallowingimportor

manufacturing of drugs.

Review of NDA.

Designation of drugs to be submitted for reex-

amination and reevaluation.

Judgments concerning the payment of relief

funds under the provisions of the ADR Relief

and Research Promotion Fund Law.

For such purpose, the PAFSC is organized into 16

committees and 21 subcommittees.

The Pharmaceuticals and Medical Devices

Agency (PMDA or Kiko in Japanese)

In 2005, there were significant revisions to the

Japanese PAL, requiring Third Party certification

systems for new low-risk and priority high-risk

medicines and devices.

In preparation for this, in April 2004, the Phar-

maceutical and Medical Device Evaluation Center

(PMDEC), the Japan Association for the Advance-

ment of Medical Equipment (JAAME) and the

Organization for Pharmaceutical Safety and

Research (OPSR) were merged and integrated in

the National Institute of Health Sciences. This

35.1 ORGANIZATION OF JAPANESE HEALTH AUTHORITIES 489