国内外药品数据可靠性监管法规的比较研究
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篇名: 国内外药品数据可靠性监管法规的比较研究
TITLE:
摘要: 目的:为进一步提升药品生产企业的数据可靠性管理水平提供参考。方法:介绍美国FDA、世界卫生组织(WHO)、英国药品和医疗保健用品管理局(MHRA)以及国际药品监管公约/药品监管合作计划(PIC/S)的药品数据可靠性监管法规,并与我国食品药品监督管理总局(CFDA)相关法规进行对比研究。结果与结论:经比较,发现国内外均较重视药品生产企业的数据可靠性管理,所发布的有关数据可靠性监管法规各有特色。首先,美国FDA、WHO、英国MHRA、PIC/S和CFDA都强调了应对系统设置访问权限,任何进入系统的人员都应经过授权,从而确保数据的保密性和可靠性;其次,对于审计追踪功能,美国FDA、英国MHRA、WHO和CFDA都作了明确要求;再次,在记录的形式方面,美国FDA和英国MHRA均强调了纸质记录和电子记录之间的等效性,WHO则要求手写原始数据必须录入计算机化系统,使得数据可追溯,CFDA则表示两者均可接受;最后,国内外药监机构都很重视风险管理工具的使用。但我国法规对于进入计算机化系统人员授权的唯一性、保证纸质数据和电子数据之间的等效性等问题的规定仍有欠缺。
ABSTRACT: OBJECTIVE: To provide reference for further improving the management of data integrity in drug manufacturing enterprises. METHODS: From perspective of drug data integrity supervision regulations of FDA, World Health Organization(WHO),UK Medicines and Healthcare Products Regulatory Agency (MHRA) and Pharmaceutical Inspection Co-operation Scheme(PIC/S),comparative study was performed according to the relevant laws and regulations of China Food and Drug Administration (CFDA). RESULTS & CONCLUSIONS: By comparison, data integrity management of pharmaceutical manufacturing enterprises has been paid more attention at home and abroad, and the relevant regulatory regulations on data integrity issued by them have their own characteristics. Firstly, FDA, WHO, MHRA, PIC/S and CFDA emphasize that system access rights should be set, and that anyone entering the system should be authorized so as to ensure data confidentiality and integrity. Secondly, for audit trail function, FDA, MHRA, WHO and CFDA have made clear requirements. Thirdly, both FDA and MHRA emphasize the equivalence between paper records and electronic records, while WHO requires that handwritten raw data must be entered into computer system to make the data traceable; CFDA expresses that both are acceptable. Finally, both domestic and foreign drug supervision institutions attach great importance to the use of risk management tools. However, there are still some deficiencies in China’s laws and regulations concerning the uniqueness of the authorization of personnel entering computer systems and the equivalence between paper data and electronic data.
期刊: 2018年第29卷第22期
作者: 雕钰惟,孙红,梁毅
AUTHORS: DIAO Yuwei,SUN Hong,LIANG Yi
关键字: 数据可靠性;药品生产企业;监管法规;国内;国外
KEYWORDS: Data integrity; Pharmaceutical manufacturing enterprises; Supervision regulation; Domestic; Foreign
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