2009 年 40 巻 1 号 p. 2-6
The usefulness of new drugs is evaluated by its benefit-risk assessment at the time of approval. To ensure the drug safety, the risk management plan should be consistently monitored from drug development to postmarketing stage. Many drugs have been withdrawn from the market or distribution restricted as a result of spontaneous reports of serious adverse reactions andor drug interactions. In recent years, several drugs have been withdrawn from the market or distribution restricted due to safety reasons based on postmarketing clinical trials. The implementation of a pharmacovigilance plan and risk minimization activities corresponding to the drug's characteristics is significant for the life cycle management of new drugs, as well as other old drugs.