Pharmaceutical Administration and Regulations in Japan - Nihs

Opium and
powdered
opium
Stimulants
Raw materials
of stimulants
Clinical study
drugs
Investigational
products for
post-marketing
clinical trials
Biological
products
Specified
biological
products
Opium and powdered opium obtained by concentration and processing of
the liquid extract from the opium poppy. Opium and powdered opium
processed as drugs are not controlled by the Opium Law but regulated as
narcotics under the narcotics and psychotropics classification.
Stimulants are drugs specified as drugs which are habit-forming, can
cause severe damage when abused and have potent stimulant effects.
The stimulants specified in the Stimulants Control Law include
phenylaminopropanes (amphetamines), phenylmethylaminopropanes
(methamphetamines), their salts and products containing them.
Raw materials for stimulants are specified in the Attached Table of the
Stimulants Control Law” and “Government Ordinance on Specifications of
Raw Materials for Stimulants.”
Clinical study drugs are drugs used in either pre- or post-marketing clinical
trials, namely investigational products or drugs or other compounds used
as comparator drugs in such trials.
Investigational products for post-marketing clinical trials are drugs or
comparator drugs used in post-marketing clinical trials.
Biological products are drugs, quasi-drugs, cosmetics, or medical devices
using materials manufactured from humans or other organisms (excluding
plants) as raw materials or packaging materials, which are designated by
the Minister of Health, Labour and Welfare as requiring special
precautions in terms of public health and hygiene.
Specified biological products are biological products designated by the
Minister of Health, Labour and Welfare as requiring measures to prevent
the onset or spread of risk to public health and hygiene due to the
biological product concerned after selling, leasing or giving.
2011-3 - 59 -