Pharmaceutical Administration and Regulations in Japan - Nihs

3.16 Adverse Drug Reaction (ADR) and
Infection Reporting
When marketers of drugs are informed of
any adverse reactions, infections, etc. as
specified by MHLW ordinance for trial
products or their marketed products, they
must report them to the Minister within the
specified period (Notification No. 0317006
dated March 17, 2005).
As of December 28, 1999, the use of the
Japanese version of ICH MedDRA
(MedDRA/J) was authorized for reporting of
adverse drug reactions and infectious
diseases and its use was enforced on April 1,
2004 (Notification No. 0325001 of the Safety
Division and Notification No. 0325032 of the
Evaluation and Licensing Division, PMSB
dated March 25, 2004).
Since October 27, 2003, electronic
adverse drug reaction reports have been
accepted (Notification No. 0828010 of the
Safety Division dated August 28, 2003. Refer
to the following site). The reports are
required to be sent to the PMDA from April 1,
2006 (Partial Modification of the
Pharmaceutical Affairs Law In accordance
with the Special Corporation Rationalization
Plan dated March 25, 2004).
The final report of the “Study group on
identification and prevention of recurrences
of drug-induced hepatitis” published in March
2010 discusses problems and future
Pharmaceutical Regulations in Japan:
prospects related to the drug adverse event
reporting system, pharmacovigilance
programs, and the problems of off-label drug
use and use of unapproved drugs.
http://www.mhlw.go.jp/shingi/2010/03/s03
00-1.html
3.17 Dissemination of Information
Marketers of drugs or medical devices,
wholesalers, marketers or leasers of medical
devices, and overseas restrictive approval
holders are asked collect and examine
information on efficacy, safety, and proper
use of drugs and medical devices and supply
such information to health professionals such
as physicians and pharmacists.
3.18 Measures related to the Law
Concerning Access to Information
Held by Administrative Organizations
With the enactment of the Law
Concerning Access to Information Held by
Administrative Organizations on April 1,
2000, anyone has the right to request
disclosure of documents retained by national
government organizations. This law covers
disclosure of documents retained by
government organizations except those
concerning non-disclosable information such
as information on individuals, information on
corporations, etc. This was partially
amended by Cabinet Order No. 371,
2011-3 - 33 -