FDA, OECD及CFDA (NMPA) GLP法规比较——系列3
来源:宁波熙宁检测技术有限公司    |    发布时间:2020-12-15 09:23:00    |    点击:


GLP/非临床研究质量管理规范

CFDA (NMPA)

第二章 第四条 术语及其定义

(一)非临床研究质量管理规范,指有关非临床安全性评价研究机构运行管理和非临床安全性评价研究项目试验方案设计、组织实施、执行、检查、记录、存档和报告等全过程的质量管理要求。

FDA

-

OECD

Section I 2.1

1. Good Laboratory Practice (GLP) is a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.

同:

虽然FDA没有给出定义,但从内容来讲,三部法规对GLP的定义是相同的。法规围绕着非临床安全性评价研究从方案设计到报告归档全过程对质量要求进行描述。但笔者以为CFDA使用质量管理一词不够准确,使用质量要求更为恰当。正如OECD使用了质量体系一词,而没有使用质量管理体系。


Study/研究

CFDA (NMPA)

第二章 第四条 术语及其定义

(二)非临床安全性评价研究,指为评价药物安全性,在实验室条件下用实验系统进行的试验,包括安全药理学试验、单次给药毒性试验、重复给药毒性试验、生殖毒性试验、遗传毒性试验、致癌性试验、局部毒性试验、免疫原性试验、依赖性试验、毒代动力学试验以及与评价药物安全性有关的其他试验。

FDA

§58.3

(d) Nonclinical laboratory study means in vivo or in vitro experiments in which test articles are studied prospectively in test systems under laboratory conditions to determine their safety. The term does not include studies utilizing human subjects or clinical studies or field trials in animals. The term does not include basic exploratory studies carried out to determine whether a test article has any potential utility or to determine physical or chemical characteristics of a test article.

OECD

Section I 2.3

1. Non-clinical health and environmental safety study, henceforth referred to simply as “study”, means an experiment or set of experiments in which a test item is examined under laboratory conditions or in the environment to obtain data on its properties and/or its safety, intended for submission to appropriate regulatory authorities.

同:

关键词相同-实验室条件下、安全性评价

异:

因三个法规的适用范围不同,其对study的定义也相应有所不同。Study的范围大小也为:OECD>FDA>CFDA

OECD GLP study除实验室环境以外,还可以是温室条件或田间条件等。


Test Facility/研究机构

CFDA (NMPA)

第二章 第四条 术语及其定义

(三)非临床安全性评价研究机构(以下简称研究机构),指具备开展非临床安全性评价研究的人员、设施设备及质量管理体系等条件,从事药物非临床安全性评价研究的单位。

FDA

§58.3

(g) Testing facility means a person who actually conducts a nonclinical laboratory study, i.e., actually uses the test article in a test system. Testing facility includes any establishment required to register under section 510 of the act that conducts nonclinical laboratory studies and any consulting laboratory described in section 704 of the act that conducts such studies. Testing facility encompasses only those operational units that are being or have been used to conduct nonclinical laboratory studies.

OECD

Section I 2.2

1. Test facility means the persons, premises and operational unit(s) that are necessary for conducting the non-clinical health and environmental safety study.

同:

三部法规定义相同


Multi-site Study/多场所研究

CFDA (NMPA)

第二章 第四条 术语及其定义

(四)多场所研究,指在不同研究机构或者同一研究机构中不同场所内共同实施完成的研究项目。该类研究项目只有一个试验方案、专题负责人,形成一个总结报告,专题负责人和实验系统所处的研究机构或者场所为“主研究场所”,其他负责实施研究工作的研究机构或者场所为“分研究场所”。

FDA

-

OECD

Section I 2.2

For multi-site studies, those which are conducted at more than one site, the test facility comprises the site at which the Study Director is located and all individual test sites, which individually or collectively can be considered to be test facilities.

Section I 2.2

2. Test site means the location(s) at which a phase(s) of a study is conducted.

同:

CFDAOECD对多场所研究、主研究场所和分研究场所的定义相同。当一项研究在同一个组织内实施时,如果需要在多个场所进行,而这些场所相互独立或地理上远离,应作为多场所研究进行管理,需要其中一个场所作为主场所,其他作为分场所。

OECD对主研究场所的定义较为绕口,但结合上文对研究机构的定义,表达的意思与CFDA应是一致的。

异:

FDA- 当前版本中没有多场所研究的概念,但是在其拟修订升级版本中有增加多场所研究。

Test Facility Management/机构负责人

CFDA (NMPA)

第二章 第四条 术语及其定义

(五)机构负责人,指按照本规范的要求全面负责某一研究机构的组织和运行管理的人员。

FDA

-

OECD

Section I 2.2

3. Test facility management means the person(s) who has the authority and formal responsibility for the organisation and functioning of the test facility according to these Principles of Good Laboratory Practice.

:

OECDCFDA定义相同

Study Director/专题负责人

CFDA (NMPA)

第二章 第四条 术语及其定义

(六)专题负责人,指全面负责组织实施非临床安全性评价研究中某项试验的人员。

FDA

§58.3

(m) Study director means the individual responsible for the overall conduct of a nonclinical laboratory study.

OECD

Section I 2.2

6. Study Director means the individual responsible for the overall conduct of the nonclinical health and environmental safety study.

同:

三部法规定义相同

Principle Investigator/主要研究者

CFDA (NMPA)

第二章 第四条 术语及其定义

(七)主要研究者,指在多场所研究中,代表专题负责人在分研究场所实施试验的人员。

FDA

-

OECD

Section I 2.2

7. Principal Investigator means an individual who, for a multi-site study, acts on behalf of the Study Director and has defined responsibility for delegated phases of the study. The Study Director’s responsibility for the overall conduct of the study cannot be delegated to the Principal Investigator(s); this includes approval of the study plan and its amendments, approval of the final report, and ensuring that all applicable Principles of Good Laboratory Practice are followed.

:

OECDCFDA定义相同

Sponsor/委托方

CFDA (NMPA)

第二章 第四条 术语及其定义

(八)委托方,指委托研究机构进行非临床安全性评价研究的单位或者个人。

FDA

§58.3

(f) Sponsor means:

(1) A person who initiates and supports, by provision of financial or other resources, a nonclinical laboratory study;

(2) A person who submits a nonclinical study to the Food and Drug Administration in support of an application for a research or marketing permit; or 

(3) A testing facility, if it both initiates and actually conducts the study.

OECD

Section I 2.2

5. Sponsor means an entity which commissions, supports and/or submits a non-clinical health and environmental safety study.

异同比较:

OECDFDA GLP中关于sponsor的定义基本一致,而CFDA GLP中委托方的定义较为局限。

CFDA GLP中委托方为委托研究机构的单位或个人,而OECD/FDA GLPSponsor还包含了研究机构本身自己作为发起非临床研究的发起者或向法规机构提交非临床研究的单位或个人。

QAU/质量保证部门

CFDA (NMPA)

第二章 第四条 术语及其定义

(九)质量保证部门,指研究机构内履行有关非临床安全性评价研究工作质量保证职能的部门,负责对每项研究及相关的设施、设备、人员、方法、操作和记录等进行检查,以保证研究工作符合本规范的要求。

FDA

§58.3

(l) Quality Assurance Unit means any person or organizational element, except the study director, designated by testing facility management to perform the duties relating to quality assurance of nonclinical laboratory studies.

OECD

Section I 2.2

8. Quality Assurance Programme means a defined system, including personnel, which is independent of study conduct and is designed to assure test facility management of compliance with these Principles of Good Laboratory Practice.

异同比较:

三部法规定义相同


对于QA独立性的描述,CFDAOECD的描述均为独立于研究的实施,而FDA的描述为SD不可以被指派为QA

SOP/标准操作流程

CFDA (NMPA)

第二章 第四条 术语及其定义

(十)标准操作规程,指描述研究机构运行管理以及试验操作的程序性文件。

FDA

-

OECD

Section I 2.2

9. Standard Operating Procedures (SOPs) means documented procedures which describe how to perform tests or activities normally not specified in detail in study plans or test guidelines.

异同比较:

CFDA GLPSOP的定义包含描述研究机构管理的程序性文件,而OECD的定义中仅涉及实验操作方面。



参考文献:

Ø  US FDA Good Laboratory Practice Regulations 21 CFR 58effective June 20, 1979 and subsequent amendments

Ø  OECD Principles of Good Laboratory Practice, as revised in 1997 and adopted November 26th, 1997 by decision of the OECD Council [C (97)186/Final]

Ø  国家食品药品监督管理总局,药物非临床研究质量管理规范,201791日生效


欢迎各位同行进行勘误及指出不足之处。