Abstract: ObjectiveTo research isotretinoin post-marketing risk control in America, and make reference for developing sophisticated drug post-marketing risk management system in our country. MethodsDrug post-marketing risk management regulation and guidance of America were looked up, the risk control measurements against teratogenesis and depression induced by isotretinoin were analyzed, and the risk control carried out by America and China were compared. ResultsFDA conducts a series of risk manage measures, such as medication guide dispensed with prescription, specific requirement which prescribers, patients, pharmacies and wholesalers must follow to assure safe use, evaluating the effect of risk mitigation periodically and improving accordingly, as a result, they control the risk to a large extent. ConclusionDrug post-marketing risk control concepts and designs are useful references for China.

Key words: isotretinoin, risk evaluation and mitigation strategies, iPLEDGE