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美国药品注册申请人合规管理机构设置情况及对我国的启示
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| 篇名： | 美国药品注册申请人合规管理机构设置情况及对我国的启示 |
| TITLE： | Establishment of Drug Registration Applicant Compliance Management Organizations in the United States and Its Enlightenment to China |
| 摘要： | 目的：为进一步完善我国药品注册申请人合规管理机构设置提供借鉴。方法：系统介绍和分析美国药品注册申请人合规管理机构的设置情况、职能配置以及运行机制，并为完善我国药品注册申请人合规管理机构设置提出建议。结果与结论：美国药品注册申请人合规管理机构包括2个层级：在FDA局长办公室层级，合规政策委员会负责确保所有合规政策在FDA监管领域内的实施具有一致性；在药品审评和研究中心以及监管事务办公室层级，合规管理职能主要由药品审评和研究中心下设的新药办公室、仿制药办公室、合规办公室、沟通办公室，以及监管事务办公室下设的政策与风险管理办公室、合规办公室、生物学研究监测办公室和药品质量办公室共同承担，其工作职责包括制定合规文件与合规程序，开展合规教育、合规指导、合规检查，并对违规行为进行处罚等。在药品注册申请提交前阶段，沟通办公室的合规教育职能以及新药办公室/仿制药办公室的合规指导职能发挥着重要作用；在提交申请阶段，新药办公室/仿制药办公室负责申报资料合规审查；在审评申报资料阶段，审评和研究中心的新药办公室/仿制药办公室、合规办公室通过与监管事务办公室的合规办公室、生物学研究监测办公室和药品质量办公室的协作来确保申报资料合规。我国药品注册申请人合规管理机构设置还处于初步探索阶段，建议可借鉴美国相关经验，建立多层级的合规管理组织架构、设置独立的合规教育部门、加强审评部门与合规检查部门的协作，以进一步提升我国药品注册申请人的合规管理水平。 |
| ABSTRACT： | OBJECTIVE：To provide reference for further improving the establishment of drug registration applicant compliance management organizations in China. METHODS ：Through introducing and analyzing the establishment ，responsibility configuration and operation mechanism of drug registration applicant compliance management organizations in the United States ，the suggestions were put forward for improving the establishment of drug registration applicant compliance management institutions in China. RESULTS & CONCLUSIONS ：There were two levels of compliance management organizations for drug registration applicant in the United States ；at Office of the Commissioner of FDA level ，the Compliance Policy Council was responsible for ensuring consistency in the implementation of all compliance policies in the FDA regulated area ；at the level of Center for Drug Evalution and Research （CDER）and Office of Regulatory Affairs （ORA），the compliance management function was mainly undertaken by Office of New Drugs （OND），Office of Generic Drugs （OGD），Office of Compliance （OC） and Office of Communication （OCOMM）under CDER ，as well as Office of Policy and Risk Management （OPRM），OC，Office of Bioresearch Monitoring Operations（OBIMO）and Office of Pharmaceuticl Quality Operations （OPQO）under ORA ，which were responsible for developing compliance documents and procedures ，carrying out compliance education ，compliance guidance ，compliance inspection and punishment for violations. Before submission stage of drug registration application ，the compliance education function of OC and the compliance guidance function of OND/OGD played an important role ；in the application submission stage ，OND/OGD was responsible for the compliance review of application materials ；in the stage of reviewing the application materials ，OND/OGD and OC of CDER ensured drug compliance through collaboration with OC ，OBIMO and OPQO of ORA. The establishment of drug registration compliance management institutions in China was still in the preliminary exploration stage. It is suggested that China can learn from the relevant experience of the United States ，establish a multi-level or ganization structure ，set up an independent compliance education department ， and strengthen thecooperation between evaluation department and compliance inspection department ，and to improve the level of compliance management of drug registration applicants in China. |
| 期刊： | 2020年第31卷第12期 |
| 作者： | 姚怡，赵艳蛟，凡馨，陈永法 |
| AUTHORS： | YAO Yi，ZHAO Yanjiao ，FAN Xin，CHEN Yongfa |
| 关键字： | 合规管理机构；药品注册；申请人；美国；中国 |
| KEYWORDS： | Compliance management organization ；Drug |
| 阅读数： | 306 次 |
| 本月下载数： | 8 次 |
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