Pharmaceutical Administration and Regulations in Japan - Nihs

3.1 Definition of Drugs
Drugs subject to the regulations in the
Pharmaceutical Affairs Law are defined as
follows in Article 2, Paragraph 1 of the
Pharmaceutical Affairs Law. The term
"drugs" refers to the following substances.
1) Substances listed in the Japanese
Pharmacopoeia.
2) Substances (other than quasi-drugs),
including dental materials, medical
supplies, and sanitary materials, which
are intended for use in the diagnosis,
treatment, or prevention of disease in
humans or animals, and which are not
equipment or instruments.
3) Substances (other than quasi-drugs or
cosmetics) which are intended to affect
the structure or functions of the body of
humans or animals, and which are not
equipment or instruments.
The specifications used to judge
whether or not a substance ingested
orally corresponds to a drug were
specified in Notification No. 476 of the
PAB, MHW dated June 1, 1971, but the
“Specifications on the Range of Drugs”
were revised (Notification No. 0331009
of the Pharmaceutical and Food Safety
Bureau (PFSB), MHLW dated March
31, 2004).
3.2 Classification of Drugs
Drugs (medicinal products) (“iyakuhin” in
Pharmaceutical Regulations in Japan:
Japanese) can be classified as follows based
on the regulatory provisions in the
Pharmaceutical Affairs Law, etc.
1) Classification according to use and
supply
(1) Prescription drugs
Drugs intended for use by a
physician or dentist or under the
prescription or instructions of a
physician or a dentist
(2) Non-prescription (OTC) drugs
Drugs other than prescription drugs
that are intended for use at the
discretion of general consumers by
direct purchase in a pharmacy or
drug store under guidance by
pharmacist
* The Law for Partial Amendment of
the Pharmaceutical Affairs Law (Law
No. 69 enforced in 2009) issued on
June 14, 2006 to define
non-prescription (OTC) drugs as the
drugs not having very strong
intended actions (indications) in
humans and those to be selected by
users based on information provided
by pharmacists or other medical
personnel and to classify them in
three types based on the degree of
risk: Type 1 (highly risky), Type 2
(moderately risky) and Type 3
(relative low risky) (enforced on April
1, 2007).
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