关键词: font-size:medium, ">年度报告制度；药品年度报告采集模块；智慧监管；信息化

Abstract: The drug annual report system is an important means of life cycle management of drugs, especially for drug post-marketing management. China′s drug annual report system was proposed in the newly revised Drug Administration Law of the People′s Republic of China in 2019 for the first time. In recent years, National Medical Products Administration (NMPA) organized to formulate and issued the Provisions on the Administration of Annual Reports of Drugs and built the drug annual report collection module, which effectively promoted smart supervision and comprehensively strengthened the capacity building of drug supervision. At the same time, with the aid of drug annual report collection module, NMPA realized the independent and timely summary of drug in-production situations, which offered help in promoting production and ensuring supply, and provided a useful back-up to the post-marketing supervision of conditionally approved drugs. This study summarized the drug annual report informatization in foreign countries, reviewed the policy background of drug annual report system in China, analyzed the drug annual report informatization in China and put forward the optimization directions for the drug annual report informatization, so as to provide reference for the continuous optimization of the drug annual report collection module, and promote the continuous implementation of the drug annual report system and the continuous improvement of the drug annual report collection module.

Key words: font-size:medium, ">Annual report system； Drug annual report collection module； Smart supervision； Informatization