审评质量管理评介及中药审评质量管理进展与建议

Evaluation on review quality management and progress and suggestions of reform in traditional Chinese medicine review

高效管理审评工作是各国药品监管部门的首要职责,管理方法主要包括良好审评规范(GRP)和ISO 9001质量管理标准等。2015年,中共中央国务院《关于改革药品医疗器械审评审批制度的意见》将健全审评质量控制体系纳入药品审评审批改革的内容。为了完成这一任务,中药审评部门通过缩短审评时限,加强沟通交流,出台技术指导原则,起草和实施具有指导作用的审评模板实践,开展多元化培训和绩效评估等,使中药审评的规范性不断加强,有效保障了中药新药的科学性和一致性。然而目前中药审评质量管理体系尚不成熟,建议通过运用ISO 9001质量管理方法管理审评工作,借鉴GRP方法加强审评过程档案的管理,运用质量评价指标提高审评质量管理水平等措施,进一步完善中药审评管理体系。

Efficient management and evaluation is the primary responsibility of drug regulatory authorities in various countries,whose management services are mainly delivered in accordance with the Good Review Practices(GRPs)and ISO 9001 quality management system.In 2015,Opinions on Reforming the Evaluation and Approval System of Drugs and Medical Devices included the perfection of quality control review system as the content of reform in drug review and approval.On this basis,the traditional Chinese medicine(TCM)review authority has shortened the review time,strengthened the communication,offered technical guidelines,designed the review template with guiding significance,and carried out diversified training and performance evaluation,to continuously strengthen the standardization of TCM review and approval and effectively guarantee the scientificity and consistency of new TCMs.However,the current quality management system for TCM review is not yet mature.It is recommended to employ ISO 9001 quality management system to manage the review work,utilize the GRP for better management of the archive files in the review process,and use quality evaluation indicators to improve the review quality management,thereby further perfecting the TCM review management system.