Principles and Practice of Pharmaceutical Medicine

consolidated a unified organization for the regula-
tion of pharmaceuticals, biologicals and medical
devices, and thus now became the Pharmaceu-
ticals and Medical Devices Agency (PMDA) (see
Figure 35.2).
The main activities of the PMDA are to offer the
pharmaceutical industry consultations with regard
to clinical trial protocols and drug and medical
devices development plans, to conduct new drug
application review and to confirm the quality of the
submitted data. The PMDA, or Drug Agency, is
composed of 15 offices to conduct different ser-
vices (see Figure 35.3).
Main offices related to new drug application,
approval review, drug safety issues, reexamination
and re evaluation are as follows.
Office of New Drug I. This division takes in
charge anti-HIV agents, anti-malignant tumor
agents, anti-bacterial agents and related drugs.
Office of New Drug II. This division operates
review of cardiovascular drugs, metabolic disease
drugs when in combination withother drugs, repro-
ductive system drugs, anal and urogenital drugs,
and diagnostics and radiopharmaceuticals forin
vivouse.
Office of New Drug III. This division takes care
of hormonal agents, metabolic disease drugs when
not in combination with other drugs, dermatologic
agents, gastrointestinal tract agents, central and
peripheral nervous system drugs, sensory organ
agents, antiallergy drugs, respiratory tract drugs
and narcotics.
Office of Biologics. This department reviews files
for biological products, and cell- and tissue-derived

products. It is also involved in agents used in gene

therapy.

Office of OTC and Generics. This division

reviews applications for approval of generics,

non-prescription drugs (OTC), quasi-drugs and

cosmetics.

Office of Medical Devices. Medical devices

and in vitro diagnostics are reviewed by this

department.

Office of Safety. This office collects, organizes

and analyzes safety information from drugs

and medical devices, in collaboration with

some other offices from the ministry, and par-

ticipates in the dissemination of the safety

information.

Office of Compliance and Standards. In this

department, data compliance to good laboratory

practice (GLP), good clinical practice (GCP) and

good post-marketing surveillance practice

(GPMSP) is carefully controlled. Applications

are checked to determine if they were prepared

according to the Criteria for Reliability of Applica-

tion Data.

PMDA covers a wide range of other services,

such as guidance for the development of orphan

drugs, communication with drug consumers,

guidance on the necessity of different types of

certificates. One of the most important services

is the ‘Kiko consultation’. Starting 1 April

1997, with the Drug Organization, PMDA

carries on today several types of consultations

(19 subtypes) for the pharmaceutical industry.

The main consultations for drug development

are

on initial plans for clinical trials (phase I);

at the end of phase IIa and at the end of phase

IIb;

before filing (dealing with long-term trials or

pre-NDA consultation, checking the acceptabil-

ity of the NDA);

on protocols.

Fees of ¥0.5–3.3 million are charged for consulta-

tion services; records of the guidance and advices

Figure 35.2 Birth of the PMDA

490 CH35 JAPANESE REGULATIONS