Pharmaceutical Administration and Regulations in Japan - Nihs

the basis of an order issued in cases where it
is judged necessary to take the following
measures based on an review by the
PAFSC. Guidelines for the preparation of
such information were specified in an MHW
notification in 1989 (Notification No.160 the
Safety Division, PAB dated October 2, 1989).
(1) New or revised Warnings: New or
important revisions of warnings.
(2) Revisions of Precautions: Urgent and
important revisions based on cases of
death, disability, or events that may lead
to death or disability, or irreversible
ADRs suspected to be due to the drug
concerned.
(3) Changes in indications: Important
changes in indications for reasons
related to safety.
(4) Changes in dosage and administration:
Important changes in dosage and
administration for reasons related to
safety.
(5) Changes in regulatory classification:
Changes in the regulatory classification,
such as designation as a poisonous
substance, deleterious substance,
prescription drug or habit-forming drug,
for reasons related to safety.
(6) Discontinuation of marketing or recall:
Discontinuation of marketing or recall of
a drug for reasons related to safety.
(7) Cancellation of approvals: Cancellation
of approvals for reasons related to
Pharmaceutical Regulations in Japan:
safety.
(8) Others: Other measures that require the
dissemination of urgent and important
information for reasons related to safety.
2) Format and content
Emergency safety information must be
prepared in the format specified in the
guidelines, using yellow paper, etc.
3) Methods of distribution
(1) The staff (MR) [refer to Appendix] in
charge of drug information of the drug
manufacturer and marketer directly
distributes the information to physicians,
pharmacists, and other health
professionals in medical institutions.
The manufacturer and marketer must
also ascertain that wholesalers market
all of the drugs concerned currently in
stock with the revised package insert
included.
(2) Efforts must be made to disseminate the
information as widely as possible by
publishing it in journals of medical or
pharmaceutical organizations, such as
the Journal of the Japan Medical
Association, Journal of the Japan
Pharmaceutical Association and the
Journal of the Japanese Association of
Hospital Pharmacists, and, if needed, in
the Journal of the Japan Dental
Association.
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