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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 Δ

姚 怡 ，赵艳蛟，凡 馨，陈永法（中国药科大学国际医药商学院，南京 211198）
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中图分类号 R95 文献标志码 A 文章编号 1001-0408（2020）12-1414-05
DOI 10.6039/j.issn.1001-0408.2020.12.02

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。
关键词 合规管理机构；药品注册；申请人；美国；中国

Establishment of Drug Registration Applicant Compliance Management Organizations in the United States
and Its Enlightenment to China
YAO Yi，ZHAO Yanjiao，FAN Xin，CHEN Yongfa（School of International Pharmaceutical Business，China
Pharmaceutical University，Nanjing 211198，China）

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 organization structure，set up an independent
compliance education department， and strengthen the
Δ 基金项目：国家社会科学基金资助项目（No.15BZZ052）；中国
cooperation between evaluation department and compliance
药科大学“双一流”学科创新团队建设项目（No.CPU2018GY40）
inspection department，and to improve the level of compliance
＊ 硕 士 研 究 生 。 研 究 方 向 ：医 药 政 策 与 法 规 。 电 话 ：025-
86185038。E-mail：yaoyicpu@163.com management of drug registration applicants in China.
# 通信作者：教授，博士生导师。研究方向：国内外药事法规与药 KEYWORDS Compliance management organization；Drug
品评价。电话：025-86185038。E-mail：cyf990@163.com registration；Applicant；The United States；China

·1414 · China Pharmacy 2020 Vol. 31 No. 12 中国药房 2020年第31卷第12期