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药物的安全性关系到病人的生命。因此,在新药研制过程中需进行各种毒性试验和其它试验,以确保用药安全。当新药经批准上市后,药物上市后的监察(post-marketing surveillance,PMS)就成为保证药物安全的重要措施。本文将介绍PMS的内容及美国和日本是如何实现药物的PMS。
Drug safety is related to the patient’s life. Therefore, in the development of new drugs need to conduct a variety of toxicity tests and other tests to ensure drug safety. Post-marketing surveillance (PMS) becomes an important measure to ensure drug safety when new drugs are approved for marketing. This article describes the content of PMS and how PMS is implemented in the United States and Japan.