我国建立药品审评与审批质量管理规范的必要性与内涵.doc

摘要 在全球范围内，为了最大程度地保护和促进公众健康，制药业都是一个受各国政府高度监管的行业。包括我国在内的世界各国都对药品的上市准入采取许可制度。绝大部分国家需要对企业所提交的上市申请进行独立的技术审评和审批。虽然国际人用药品注册技术要求国际协调会（ICH）的成立和推广极大程度上地统一了各国对药品在不同地区/国家申请批准时所需的数据要求，但在全球范围内，无论是工业界还是药品监管机构都意识到，监管机构在对上市申请的审评质量、审评效率、审评结果的明确性/可预见性和透明度方面都有待提高。近年来，美国食品药品监督管理局（FDA）率先试图通过建立“药品审评质量管理规范（GRP）”，以应对这样的挑战， 并取得了良好的成效。本论文通过对美国已建立的及配套法规，以及这些法规实施后产生的影响的，结合本企业在我国药品申报和注册中的一些案例对我国药品监管机构（下属）在审评质量、审评管理规范性方面存在的问题进行诊断和分析。 结合我国国情以及行业特点，参照国外药品监管机构已制订的“药品审评质量管理规范”以及细则， 展望在我国建立“药品审评和审批质量管理规范（GRRP）”的必要性和内涵， 并提出具体的框架。旨在为我国的药品审评/审批建设规范的审评程序、提高审评质量，效率，可预见性和透明度见言献策。同时，“药品审评和审批质量管理规范”在我国的建立也将为工业界的药品研发提供明确的指南， 促使我国的新药研发尽早与发达国家接轨，实现真正地自主创新。 审评; 监管机构规范；质量； The ecessity and Implication to Establish “Good Registration and Review Practice” in China Abstract The Necessity and Implication to Establish 揋ood Registration and Review Practice攊n China的药 To best protect and promote public health, pharmaceutical industry is highly regulated by respective government worldwide. Including China, pharmaceutical product should be approved by respective regulatory agency before its market entry. Regulatory agencies of most countries perform independent technical review and approval to data included into marketing application of a pharmaceutical product submitted by applicant. Although ICH’s establishment and spread greatly harmonize the technical requirement of a marketing application approval among different countries/regions, both industry and regulatory agency all realized that regulatory bodies need to improve the quality, efficiency, clarity and transparency of review to marketing application. Recent year, USFDA tried to introduce a documented best practice, Good Review Practice (GRP) to meet the challenges. It has been awarded by both industry and public upon implementation. In this paper, author studied USFDA’s Good Review Practice (GRP) its derivative regulations as well as its significance after implementation, and tried to diagnose and analyze the existed review quality and review management related