新医薬品の市販直後調査制度について

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  • Early postmarketing phase vigilance(EPPV) for new drugs.

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Data on new drug effectiveness and safety is limited at approval because it is based on clinical trials limited by the number of patients, combination drugs, complications, patients age, etc. Once new drugs are marketed, serious adverse reactions not found in clinical trials may arise due to the rapid increase in the number of patients and clincal diversification from clinical trials. We evaluated “Early Postmarketing Phase Vigilance (EPPV)” enacted Oct. 1, 2001, by amendment of Good Postmarketing Surveillance Practices (GPMSP) of Drugs in December 2000.

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