Current status of the implementation of good clinical practice in China

被引：0

作者：

Cao C. ^{[1
,2
]}

机构：

[1] Centre for Certification of Drugs, State Food and Drug Administration, Beijing

[2] Centre for Certification of Drugs, State Food and Drug Administration, No. 11 Building, Beijing, Fahuananli, Chongwen District

来源：

International Journal of Pharmaceutical Medicine | 2006年 / 20卷 / 6期

关键词：

Good Clinical Practice; State Council; Drug Research; Dermatophytosis; Good Laboratory Practice;

D O I：

10.2165/00124363-200620060-00004

中图分类号：

学科分类号：

摘要：

If a medical institution in China wishes to carry out clinical studies on humans they must first gain accreditation from the relevant regulatory department of the State Council. The main purpose of this article is to provide readers with background information on the introduction of good clinical practice (GCP) along with information on the development and management methods currently employed in drug research in China. We then analyse the current issues for GCP implementation in China so as to help improve the implementation of these regulations. © 2006 Adis Data Information BV. All rights reserved.

引用

页码：361 / 366

页数：5

共 9 条

[1]

Drug administration law of the People's, 45, (2006)

[2]

Regulations for implementation of the drug administration law of the People's, 360, (2006)

[3]

Measures for verifying qualification of drug clinical study institutions, 2004, (2006)

[4]

Provisions for handling malpractices in drug research and registration (interim), 1999, (2006)

[5]

Rules for drug clinical study, 2000, (2006)

[6]

Provisional rules for drug research record, 2000, (2006)

[7]

Proposed measures for drug research supervision (for public comments), (2006)

[8]

Notice for setting up GCP training centres in six institutions, 2000, (2006)

[9]

Notice for adding two institutions as GCP training centres, 2001, (2006)

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