我國的《藥物警戒質量管理規(guī)范》對藥物警戒計劃的定位是藥品上市后風險管理計劃的一部分，與歐盟風險管理計劃的理念存在差異。我國將風險管理計劃按照上市前后不同階段進行了區(qū)分，上市前稱為“臨床風險管理計劃”，批準上市后將其轉化為“藥物警戒計劃”，而歐盟的風險管理計劃關注的一直是藥品的臨床使用風險，沒有進行上市前后的區(qū)分。由于我國提出風險管理計劃的理念較晚，在早期時很多有藥品出口業(yè)務的企業(yè)當時多數(shù)是以歐盟的風險管理計劃為參考制定的，所以當我國再提出上市后風險管理計劃要求時，很多人會有概念上的混淆。結合歐盟和我國近年來對藥品風險管理計劃的要求變化，厘清藥物警戒計劃和風險管理計劃之間的區(qū)別和聯(lián)系，以期幫助企業(yè)更好地開展上市后風險管理。

The positioning of pharmacovigilance plans in the "Good Quality Management Practice for Pharmacovigilance" is a part of the post-marketing risk management plan (RMP) of drugs, which differs from the concept of the EU's RMP. In China, RMP are differentiated according to different stages before and after marketing. Before marketing, they are referred to as "clinical risk management plans", and after approval for marketing, they are converted into "pharmacovigilance plans." However, the EU's RMP has always focused on the clinical use risks of drugs, without distinguishing between before and after marketing. Due to the late introduction of the concept of RMP in China, many enterprises engaged in drug export business in the early years were mostly based on the EU RMP. Therefore, when China again proposed requirements for a post-market RMP, many people would have conceptual confusion. Based on the changes in requirements for drug RMP in the EU and China in recent years, this article clarifies the differences and linkages between pharmacovigilance plans and RMP, to help enterprises correctly carry out post-marketing risk management.

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