国内外药品上市后安全性研究的报告规范要求比较

Comparison on Reporting Requirements for Drug Post-marketing Safety Studies among Different Authorities

目前我国尚缺乏药品上市后安全性研究(PASS)的报告规范及细则。在系统梳理了欧盟、美国、日本、加拿大及澳大利亚的相关报告规范指南后,本文对申请、进展、总结报告的报告要素及其内容进行了总结,以期为我国进一步完善药物警戒体系、制定相关技术指南提供参考。建议立足于流行病学研究的方法学细则,结合研究特点和我国国情,拟定PASS报告规范细则,厘清多方职责,加强监管力度,并开发PASS报告规范评价工具。

There is a lack of detailed reporting requirements and standards for drug post-marketing safety studies in China at present.The current reporting guidelines for drug post-marketing safety studies of the European Union,the United States,Japan,Canada and Australia were systematically sorted out.The reporting elements and contents of the study protocols,progress reports,and final study reports were also summarized in order to further improve the pharmacovigilance system and provide references for formulating the relevant guidelines in China.According to the results,it was recommended to formulate detailed reporting requirements and standards for drug post-marketing safety studies based on the methodological rules of epidemiological researches and national conditions in China.Authorities should clarify their responsibilities and enhance supervision according to the laws and regulations.Tools were also recommended to develop to assess the reporting quality of post-marketing safety studies.