我國(guó)的《藥物警戒質(zhì)量管理規(guī)范》對(duì)藥物警戒計(jì)劃的定位是藥品上市后風(fēng)險(xiǎn)管理計(jì)劃的一部分，與歐盟風(fēng)險(xiǎn)管理計(jì)劃的理念存在差異。我國(guó)將風(fēng)險(xiǎn)管理計(jì)劃按照上市前后不同階段進(jìn)行了區(qū)分，上市前稱(chēng)為“臨床風(fēng)險(xiǎn)管理計(jì)劃”，批準(zhǔn)上市后將其轉(zhuǎn)化為“藥物警戒計(jì)劃”，而歐盟的風(fēng)險(xiǎn)管理計(jì)劃關(guān)注的一直是藥品的臨床使用風(fēng)險(xiǎn)，沒(méi)有進(jìn)行上市前后的區(qū)分。由于我國(guó)提出風(fēng)險(xiǎn)管理計(jì)劃的理念較晚，在早期時(shí)很多有藥品出口業(yè)務(wù)的企業(yè)當(dāng)時(shí)多數(shù)是以歐盟的風(fēng)險(xiǎn)管理計(jì)劃為參考制定的，所以當(dāng)我國(guó)再提出上市后風(fēng)險(xiǎn)管理計(jì)劃要求時(shí)，很多人會(huì)有概念上的混淆。結(jié)合歐盟和我國(guó)近年來(lái)對(duì)藥品風(fēng)險(xiǎn)管理計(jì)劃的要求變化，厘清藥物警戒計(jì)劃和風(fēng)險(xiǎn)管理計(jì)劃之間的區(qū)別和聯(lián)系，以期幫助企業(yè)更好地開(kāi)展上市后風(fēng)險(xiǎn)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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