Good Clinical Practice (Exposure Draft) G/TBT/N/CHN/2123

1.

Notifying Member: CHINA

If applicable, name of local government involved (Articles 3.2 and 7.2):

2.

Agency responsible:

National Medical Products Administration

3.

Notified under Article 2.9.2 [ ], 2.10.1 [ ], 5.6.2 [X], 5.7.1 [ ],3.2 [ ], 7.2 [ ],Other:

4.

Products covered (HS codes or national tariff lines. ICS numbers may be provided in addition, where applicable): Drugs (HS code(s): 30); (ICS code(s): 11.120.10)

5.

Details of notified document(s) (title, number of pages and languages, means of access): Good Clinical Practice (Exposure Draft); (25 page(s), in Chinese)

Link to notified document(s) and/or contact details for agency or authority which can provide copies upon request:

6.

Description of content: This GCP comprises 48 articles, stipulating the quality standards for the entire process of clinical trials.

7.

Objective and rationale, including the nature of urgent problems where applicable: Protection of human health or safety

8.

Relevant documents:

-

9.

Proposed date of adoption: To be determined

Proposed date of entry into force: To be determined

10.

Provision of comments

Final date for comments: 29 November 2025

[X] 60 days from notification

Contact details of agency or authority designated to handle comments regarding the notification:

WTO/TBT National Notification and Enquiry Center of the People's Republic of China

Tel：+86 10 57954633/ 57954627

E_mail: tbt@customs.gov.cn