Pharmaceutical Administration and Regulations in Japan - Nihs

“Caution: Use only with a prescription from a
physician” and a labeling item for
manufacturer/marketing business instead of
manufacturer or importer were added (refer
to Chapter 5).
The Law for Partial Amendment of the
Pharmaceutical Affairs Law issued on June
14, 2006 (Law No. 69 enforced in 2009)
requires the manufacturer of non-prescription
drugs to prescribe in labeling matters
specified in the Law in accordance of the
level of potential risks.
To prevent medical accidents due to
misunderstandings and assure traceability,
implementation of barcode labeling for
prescription drugs (excluding in vitro
diagnostics) (Notification No. 0915001 of the
Safety Division, PFSB dated September 15,
2006) and preparation of medication guides
for patients are being promoted so that the
patient understands the prescription drug
correctly and serious adverse drug reactions
can be discovered at an early stage
(Notification No. 0228001 of the Safety
Division, PFSB and No. 0228002 of the
Compliance and Narcotics Division, PFSB
dated February 28, 2006).
Article 28 (Second-Class License for
Selling Drugs) and Article 29 (Prohibition of
Selling Designated Drugs) were amended by
Law No. 69 dated June 14, 2006 entitled
“Law to Partially Amend the Pharmaceutical
Affairs Law”, and the regulatory classification
Pharmaceutical Regulations in Japan:
“designated drug” was abolished on June 1,
2009. After amendment of the Law, it is no
longer necessary to specify “designated
drug” but as an interim measure, the old
labeling system can be used in
manufacturing for one year and in product
marketing for 2 years.
3.11 Restrictions and Prohibition of
Advertising
The following restrictions on advertising
are enforced to ensure proper use of drugs:
prohibition of advertising of prescription
drugs aimed at the general consumer,
advertising of the name, manufacturing
method and/or indications of a drug before
approval, and false or exaggerated
statements (Notification No. 1339 of the PAB
dated October 9, 1980).
With the recent increased awareness of
the public concerning health and the spread
of the Internet, there have been cases of
advertisement of unapproved drugs by
persons acting as importers. Therefore, a
notification has been issued concerning
guidance and control of individual importers
including items related to drug advertising
(Notification No. 0828014 of the PFSB dated
August 28, 2002).
3.12 Good Laboratory Practice (GLP)
GLP specifies standards that must be met
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