Good Data and Record Management Practices (Draft) G/TBT/N/CHN/1254

1.

Notifying Member: China

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

2.

Agency responsible: China Food and Drug Administration

Name and address (including telephone and fax numbers, email and website addresses, if available) of agency or authority designated to handle comments regarding the notification shall be indicated if different from above:

3.

Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [X], 5.7.1 [  ], other:

4.

Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Drugs ICS: 11.120.10  HS: 30

5.

Title, number of pages and language(s) of the notified document: Good Data and Record Management Practices (Draft) (11 page(s), in Chinese)  

6.

Description of content: Good Data and Record Management Practices (GDRP) include general provisions, quality management, personnel, basic requirements of data, system and supplementary provisions, which is applicable to drug development, manufacture, distribution, post-marketing surveillance and evaluation. The data in GDRP should be complete as well as attributable, legible, contemporaneous, original and accurate, commonly referred to as "ALCOA".

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.

Final date for comments: 60 days from notification

11.

Texts available from: National enquiry point [X] or address, telephone and fax numbers and email and website addresses, if available, of other body:

WTO/TBT National Notification and Enquiry Center of the People's Republic of China
Tel.: +86 10 84603881/84603950
Fax: +86 10 84603811
E-mail: tbt@aqsiq.gov.cn
https://members.wto.org/crnattachments/2018/TBT/CHN/18_0436_00_x.pdf