Pharmaceutical Administration and Regulations in Japan - Nihs

standard operating procedures for
post-marketing safety management (GVP).
The provisions in Article 253 of the
Enforcement Regulations for reporting
adverse drug reactions specify reporting
within 15 days and within 30 days. The
cases requiring reporting within 15 days were
increased in Notification No. 0317006 of the
Pharmaceutical and Food Safety Bureau
dated March 17, 2005. This change was
intended to assure focused supervision of
serious cases caused by adverse reactions
of drugs with little post-marketing clinical
experience and to coordinate reporting
criteria for adverse drug reactions with
international standards. A summary of
these provisions is presented below.
(1) Reporting within 15 days
The following must be reported within
15 days from the time they are first
known:
a) The cases described below include
suspected adverse reactions to the
drug concerned reported both in
Japan and overseas. These also
include cases where the occurrence
of an adverse reaction, its incidence,
and/or the conditions of onset was
unexpected based on the
precautions in the package insert of
the drug concerned (previously
unknown serious cases).
Pharmaceutical Regulations in Japan:
(1) Death
(2) Disability
(3) Any events possibly leading to
death or disability
(4) Any case that requires
hospitalization for treatment or
prolongs the duration of
hospitalization.
(5) Any other serious cases
involving items (1) through (4)
above
(6) Any congenital disease or
anomaly in the offspring of a
treated patient.
b) Any case involving items (1) through
(6) above resulting from any
unknown or known infections due to
use of the drug concerned, including
cases both in Japan and overseas.
c) Any implementation of measures by
regulatory authorities in foreign
countries such as suspension of
marketing of the drug.
d) Known deaths
e) Changes in onset trends of known
serious adverse drug reactions that
would result in or increase public
health hazards.
f) Serious cases considered to be
caused by adverse reactions of
drugs with new active ingredients
within 2 years from the date of
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