Provisions for Supervision of Drug Manufacturing (Draft for Comments) G/TBT/N/CHN/1381

1.

Notifying Member: China

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

2.

Agency responsible: National Medical Products 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 [  ], 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): Glands and other organs for organo-therapeutic uses, dried, whether or not powdered; extracts of glands or other organs or of their secretions for organo-therapeutic uses; heparin and its salts; other human or animal substances prepared for therapeutic or prophylactic uses, not elsewhere specified or included (HS 3001); Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products (HS 3002); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale (HS 3003); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale (HS 3004); Pharmaceutical goods specified in Note 4 to this Chapter (HS 3006); Medicaments (ICS 11.120.10)

5.

Title, number of pages and language(s) of the notified document: Provisions for Supervision of Drug Manufacturing (Draft for Comments) (23 page(s), in Chinese)

6.

Description of content: This Provision is drafted to strengthen the supervision and administration of drug manufacturing.

7.

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

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 57954630 / 57954627
Email: tbt@customs.gov.cn

https://members.wto.org/crnattachments/2019/TBT/CHN/19_5342_00_x.pdf