G/TBT/N/MAC/37

14 April 2026

(26-2882)

Committee on Technical Barriers to Trade

Original: English

1.

Notifying Member: MACAO, CHINA

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

2.

Agency responsible:

Pharmaceutical Administration Bureau

3.

Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 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): Starting and raw materials to be used for manufacturing of biological active substances and medicines

5.

Details of notified document(s) (title, number of pages and languages, means of access): Decision No. 05/ISAF/2025; (26 page(s), in Chinese), (26 page(s), in Portuguese)

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

https://members.wto.org/crnattachments/2026/TBT/MAC/26_02035_00_x.pdf

https://bo.dsaj.gov.mo/bo/ii/2025/52/avisosoficiais_cn.asp#isaf

Economic and Technological Development Bureau

Address: Rua Dr. Pedro José Lobo, No.1-3, 2nd Floor, Macao SAR

Telephone: (853) 85972239

Fax: (853) 28712551

E-mail: dcecodco-wto@dsedt.gov.mo

6.

Description of content: The document establishes the Good Manufacturing Practices (GMP) for manufacturers of biological active substances and medicines. It sets forth the requirements that manufacturers must comply with in terms of production, control, quality, safety, and traceability to ensure the protection of public health. Starting and raw materials imported from trade for use in the manufacture of biological active substances and medicines should comply with the relevant provisions of this document.

7.

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

8.

Relevant documents:

Macao Special Administrative Region Official Gazette No. 52 Series II of 26 December 2025

9.

Proposed date of adoption: 12 December 2025

Proposed date of entry into force: 31 March 2026

10.

Provision of comments

Final date for comments: Not Applicable

[ ] 60 days from notification

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

Economic and Technological Development Bureau

Address: Rua Dr. Pedro José Lobo, No.1-3, 2nd Floor, Macao SAR

Telephone: (853) 85972239

Fax: (853) 28712551

E-mail: dcecodco-wto@dsedt.gov.mo