Research Progress of Antitumor Pharmacovigilance

Abstract

2019年我国新修订的《药品管理法》首次提出国家建立药物警戒制度，2021年我国首部《药物警戒质量管理规范》发布。药物警戒的提出和实施在我国为初始阶段，从体制、监测机制、数据库建设等方面需不断完善。我国肿瘤患者新发病例数量位居全球首位，近年来，新型抗肿瘤药物上市速度加快，临床试验繁多，抗肿瘤药物警戒工作势在必行。本文从药物警戒起源、临床实践目标、流程与方法、抗肿瘤药物警戒难点及我国药物警戒现行特点等方面归纳总结，旨在为抗肿瘤药物警戒的开展提供参考。

In 2019, Drug Administration Law of China was first time proposed that the country should establish pharmacovigilance system. In 2021, the first Pharmacovigilance Quality Management Standard of China was released. The proposal and implementation of pharmacovigilance were the initial stage in China, and it needed to improve the aspects of pharmacovigilance include institution, monitoring mechanism and database construction. The number of new diagnosed cancer patients in China ranked first in the world. In recent years, the marketing speed of novel antitumor drugs was accelerated, and there were many clinical trials. Therefore, antitumor pharmacovigilance was imperative. In this article, we summarized pharmacovigilance of the origin, clinical practice objectives, procedures, methods. We described the difficulties in antitumor pharmacovigilance and current characteristics of pharmacovigilance in China, aiming to provide reference for the development of antitumor pharmacovigilance.