Measures for Review and Approval of Drug Master File (DMF) in Support of Finished Drug Product Application (Draft) G/TBT/N/CHN/1253

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 [  ], 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: Measures for Review and Approval of Drug Master File (DMF) in Support of Finished Drug Product Application (Draft) (10 page(s), in Chinese)  

6.

Description of content: These measures are formulated to establish a drug quality management system in which marketing authorization holder is the first responsible person, to improve the quality and efficiency of drug registration, and to ensure the safety, effectiveness and quality of drug. Based on management process for review and approval of drug master file (DMF) in support of finished drug product application, these measures consist of seven parts, respectively，General Provisions, Responsibilities and Obligations, DMF Listing, Review and Approval of DMF in Support of Finished Drug Product Application, Alteration and Termination, Supervision and Management, Supplementary Articles.

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_0435_00_x.pdf