Post-marketing surveillance of drugs in Japan
- Focusing on the ADR reporting system -

Tomoko Marue

15 January 2003

Drugs are examined prudently at the time of approval for their safety and efficacy. However, the safety profile of drugs becomes more completely known only after they are marketed and used by many patients. Therefore, drugs are constantly monitored for their efficacy and safety after they are marketed. We call it post-marketing surveillance (PMS) of drugs which is conducted under the regulations of the Pharmaceutical Affairs Law.
Ms Marue gave an overview of the PMS system in Japan, focusing on adverse drug reaction reporting. She discussed how drug safety information is collected, analyzed, and reported to the health authorities; and the definition of various terms used in adverse drug reaction reporting in Japan.


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