E-DRUG: Post-Marketing Surveillance and ADR Monitoring in Japan
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Dear E-druggers,
Also in Japan, all health professionals, i.e., physicians, dentists,
pharmacists, veterinarians and others are legally supposed to report ADRs
according to "Pharmaceutical Affairs Law", revised on 12 December 2002, and
enforced on 4 April 2004.
Relevant article is as follows:
Article 77-4-2 (Reports of Adverse Reactions, etc.)
1. Manufacturers or importers and marketers of drugs, quasi-drugs, cosmetics
or medical devices, persons who have acquired foreign manufacturing approval
or their in-country caretakers must report to the Minister as specified by
MHLW ordinance when they learn of disease, disability or death suspected to
be caused by use or any other matter specified by MHLW ordinance related to
the efficacy and safety of drugs, quasi-drugs, cosmetics or medical devices
which they manufacture or import and market or have received approval to
manufacture or import and market.
2. When proprietors of pharmacies, hospitals, clinics or veterinary clinics,
or physicians, dentists, pharmacists, veterinarians or other health
professionals learn of cases of diseases, disabilities or deaths suspected
to be caused by adverse drug reactions or other reasons related to drugs or
medical devices, or infections suspected of being caused by the use of such
products, and they confirm that it is necessary to prevent the onset or
spread of the risk of harm to public health or hygiene, they must report
this fact to the Minister.
However, I think that this requirement isn't well recognized among health
professionals in Japan yet.
Kaoru Yoshida
Department of Drug Policy and Management (DPM),
Faculty of Pharmaceutical Sciences,
The University of Tokyo,
Japan
milk_cat@qj9.so-net.ne.jp