General Administration of Customs Announcement No. 254 of 2025: Improving risk classification and quarantine supervision measures for entry and exit biological materials

General Administration of Customs Announcement No. 254 of 2025

Announcement on Scientifically Improving Quarantine and Supervision Measures for Entry and Exit Biological Materials

In order to better serve China's life science research, ensure the best import and export of biological materials required for scientific research and production, coordinate development and safety, and promote the high-quality development of the biopharmaceutical industry, in accordance with relevant laws and regulations and after risk assessment, the General Administration of Customs decided to promote the quarantine supervision reform measures for entry and exit biomaterials piloted in Beijing, Tianjin, Hebei and Shanghai and other places nationwide, and scientifically improve the risk classification and quarantine supervision measures for entry and exit biological materials. The relevant matters are hereby announced as follows:

1. Dynamically adjust the 'List of Risk Level Classification Scope of Imported Biological Materials and Corresponding Quarantine Supervision Measures'

In combination with the needs of industry, scientific research, etc., the 'List of Risk Classification Scope and Corresponding Quarantine Supervision Measures for Inbound Biological Materials' (hereinafter referred to as the 'List', see Appendix 1) will be adjusted and improved , and will be published and dynamically updated on the website of the General Administration of Customs. Animal-derived gelatin for scientific research (pig skin gelatin, cowhide gelatin, fish skin gelatin) is no longer managed as biological materials and is managed as non-edible animal gelatin.

2. Further optimize quarantine supervision measures

(1) Optimize the quarantine approval of imported biological materials.

For imported level-1 risk biological materials, you should apply for the approval procedures for the franchised quarantine of imported animals and plants. The approval procedures and requirements shall be implemented in accordance with the announcement of the General Administration of Customs on franchised quarantine approval.

For imported secondary risk biological materials, you should apply for entry animal and plant quarantine approval procedures. In principle, the approval time limit of the direct customs shall not exceed 3 working days.

(2) Optimize quarantine supervision measures for imported experimental animals.

The designated isolation site use permit for experimental animals in the 'List' is allowed to be applied for once and used multiple times within the validity period. On the premise of ensuring biosafety, with the approval of the customs directly under the jurisdiction of the location of the isolation site, experiments while isolating are allowed.

The isolation and quarantine period for experimental animals in the 'List' has been reduced to 14 days. Among them, laboratory rats should provide a health monitoring report stipulated in the relevant health certificate when they are imported, or a test qualification report issued by a testing agency accredited by the China National Accreditation Service for Conformity Assessment (CNAS) after entry. For those who are unable to provide the above report, the quarantine period will remain in place for 30 days.

(3) Optimize the registration management of outbound biomaterials enterprises.

For units that produce, process, and store outbound biological materials (hereinafter referred to as outbound production units), if the importing country or region does not have registration requirements, registration management will not be implemented. If the importing country or region has registration requirements, the outbound production unit shall submit a registration application to the customs in advance and submit the 'Registration Application Form for Outbound Biological Material Production, Processing and Storage Units' (see Appendix 2) and relevant materials. The customs conducts audits in accordance with the 'Customs Administrative Licensing Management Measures of the People's Republic of China' and approves registration for those that meet the conditions. The registration is valid for 5 years.

3. Other instructions

(1) For the biological materials required to be subject to access management in the 'List', the list of approved products and the list of registered enterprises are published and dynamically updated on the website of the General Administration of Customs.

(2) Consignees of imported secondary risk biological materials should apply for registration with the local customs, and conscientiously fulfill their biosafety responsibilities, strictly implement my country's relevant biosafety management requirements, and adopt effective biosecurity measures for the transportation, storage, isolation, use, and harmless treatment of imported biological materials.

(3) If the entry and exit of biological materials involves other regulatory requirements such as entry and exit of special goods, items, etc., they shall be implemented in accordance with relevant laws, regulations and other provisions.

This announcement will be effective from December 30, 2025. If the relevant provisions in the 'Announcement of the General Administration of Quality Supervision, Inspection and Quarantine on Promoting the Pilot Experience in the Supervision of Imported Biological Materials from Beijing, Tianjin, Hebei and Shanghai and Launching a New Round of Pilots' (former General Administration of Quality Supervision, Inspection and Quarantine Announcement No. 94 of 2017) are inconsistent with this announcement, this announcement shall prevail.

Hereby announce.

Attachment: 1. Scope of risk classification of imported biological materials and list of corresponding quarantine supervision measures.xls

http://www.customs.gov.cn/customs/302249/2480148/6908697/2025122610164594518.xls

2. Application form for registration of production, processing and storage units of outbound biological materials.docx

http://www.customs.gov.cn/customs/302249/2480148/6908697/2025122610165735826.docx

General Administration of Customs

December 24, 2025

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