Policy Summary
This announcement, issued by the General Administration of Customs (GACC), implements nationwide reforms previously piloted to scientifically improve risk classification and quarantine supervision for biological materials, effective from December 30, 2025. Key measures include optimizing approval timelines, simplifying registration processes, and clarifying product management rules to serve scientific research and the biopharmaceutical industry.

Official Chinese Text

海关总署公告2025年第254号（关于科学完善进出境生物材料检疫监管措施的公告）
公告〔2025〕254号

　　为更好服务我国生命科学研究，保障科研、生产所需生物材料优进优出，统筹发展和安全，促进生物医药产业高质量发展，依据相关法律法规并经风险评估，海关总署决定将京津冀沪等地试点的进境生物材料检疫监管改革措施在全国范围推广，科学完善进出境生物材料风险分级及检疫监管措施。现就有关事宜公告如下：

　　一、动态调整《进境生物材料风险级别划分范围及相应检疫监管措施清单》

　　结合产业、科研等需要，调整完善《进境生物材料风险级别划分范围及相应检疫监管措施清单》（以下简称《清单》，见附件1），在海关总署网站对外公布并动态更新。科研用动物源性明胶（猪皮明胶、牛皮明胶、鱼皮明胶）不再作为生物材料管理，按照非食用动物明胶管理。

　　二、进一步优化检疫监管措施

　　（一）优化进境生物材料检疫审批。

　　进境一级风险生物材料，应申请办理进境动植物特许检疫审批手续，审批程序和要求按照海关总署有关特许检疫审批的公告执行。

　　进境二级风险生物材料，应申请办理进境动植物检疫审批手续。原则上直属海关审批时限不超过3个工作日。

　　（二）优化进境实验动物检疫监管措施。

　　《清单》中实验动物的指定隔离场使用证允许一次办理、有效期内多次使用。在确保生物安全的前提下，经隔离场所在地直属海关批准，允许边隔离边实验。

　　《清单》中实验动物的隔离检疫期均缩减至14天。其中，实验鼠进口时应提供有关卫生证书规定的健康监测报告，或者进境后提供中国合格评定国家认可委员会（CNAS）认可检测机构出具的检测合格报告。对无法提供上述报告的，隔离检疫期仍维持30天。

　　（三）优化出境生物材料企业注册登记管理。

　　对于出境生物材料生产、加工、存放单位（以下简称出境生产单位），输入国家或者地区无注册登记要求的，不实施注册登记管理。对输入国家或者地区有注册登记要求的，出境生产单位应事先向海关提出注册登记申请，并提交《出境生物材料生产、加工、存放单位注册登记申请表》（见附件2）及相关材料。海关按照《中华人民共和国海关行政许可管理办法》实施审核，对符合条件的准予注册登记，注册登记有效期为5年。

　　三、其他说明

　　（一）《清单》中要求实施准入管理的生物材料，已获准入产品名单和注册企业名单在海关总署网站公布并动态更新。

　　（二）进境二级风险生物材料的收货人应向所在地海关申请备案，并认真履行生物安全主体责任，严格落实我国有关生物安全管理要求，对进境生物材料运输、储存、隔离饲养、使用、无害化处理等采取有效生物安全措施。

　　（三）进出境生物材料涉及进出境特殊货物、物品等其他监管要求的，按照相关法律法规等规定执行。

　　本公告自2025年12月30日起实施。《质检总局关于推广京津冀沪进境生物材料监管试点经验及开展新一轮试点的公告》（原国家质量监督检验检疫总局公告2017年第94号）中相关规定与本公告不一致的，以本公告为准。

　　特此公告。

　　附件：

1.进境生物材料风险级别划分范围及相应检疫监管措施清单.xls

2.出境生物材料生产、加工、存放单位注册登记申请表.docx

　　海关总署

　　2025年12月24日

For Reference Only - English Translation

Critical Notice: The English text below is machine-translated and is provided solely as an aid to understanding the original document. It may contain inaccuracies, ambiguities, or errors and must not be relied upon for any legal, compliance, or commercial decision-making.

Announcement of the General Administration of Customs No. 254 of 2025
(Announcement on Scientifically Improving Quarantine Supervision Measures for Entry and Exit Biological Materials)

Announcement [2025] No. 254

To better serve China's life science research, ensure the efficient import and export of biological materials needed for research and production, balance development and security, and promote the high-quality development of the biopharmaceutical industry, based on relevant laws and regulations and risk assessment, the General Administration of Customs has decided to extend nationwide the pilot reforms for quarantine supervision of inbound biological materials previously implemented in Beijing, Tianjin, Hebei, and Shanghai, thereby scientifically improving the risk classification and quarantine supervision measures for entry and exit biological materials. Relevant matters are hereby announced as follows:

I. Dynamic Adjustment of the List of Risk Level Classification Scope and Corresponding Quarantine Supervision Measures for Inbound Biological Materials

Based on the needs of industry and scientific research, the List of Risk Level Classification Scope and Corresponding Quarantine Supervision Measures for Inbound Biological Materials (hereinafter referred to as the "List," see Attachment 1) is adjusted and improved. The List is published on the GACC website and will be dynamically updated. Animal-derived gelatin for research (porcine skin gelatin, bovine skin gelatin, fish skin gelatin) will no longer be managed as biological materials but shall be managed as non-edible animal gelatin.

II. Further Optimization of Quarantine Supervision Measures
(1) Optimization of Quarantine Approval for Inbound Biological Materials.
For inbound biological materials classified as Level 1 risk, an application for Special Quarantine Approval for Entry Animals and Plants shall be submitted. The approval procedures and requirements shall follow the relevant GACC announcements on special quarantine approvals.
For inbound biological materials classified as Level 2 risk, an application for Entry Animal and Plant Quarantine Approval shall be submitted. In principle, the approval time by the directly affiliated Customs shall not exceed 3 working days.
(2) Optimization of Quarantine Supervision Measures for Inbound Laboratory Animals.
The Designated Quarantine Facility Usage Certificate for laboratory animals specified in the List may be obtained once and used multiple times within its validity period. Under the premise of ensuring biosafety, and upon approval by the directly affiliated Customs where the quarantine facility is located, concurrent quarantine and experimentation are permitted.
The quarantine period for laboratory animals specified in the List is uniformly reduced to 14 days. For laboratory mice, a health monitoring report as stipulated by the relevant health certificate must be provided upon import, or a qualified test report issued by a testing institution accredited by the China National Accreditation Service for Conformity Assessment (CNAS) must be provided after entry. If such reports cannot be provided, the quarantine period remains 30 days.
(3) Optimization of Registration and Management for Enterprises Exporting Biological Materials.
For units producing, processing, or storing biological materials for export (hereinafter referred to as export production units), if the importing country or region has no registration requirements, registration management will not be enforced. If the importing country or region has registration requirements, export production units should apply for registration with Customs in advance and submit the Application Form for Registration of Production, Processing, and Storage Units for Export Biological Materials (see Attachment 2) along with relevant materials. Customs will conduct the review in accordance with the Administrative Measures of the Customs of the People's Republic of China for Administrative Licensing, and grant registration to qualified applicants, with the registration valid for 5 years.

III. Other Explanations
(1) For biological materials in the List subject to market access management, lists of approved products and registered enterprises are published and dynamically updated on the GACC website.
(2) Consignees of inbound Level 2 risk biological materials shall apply for filing with the local Customs and conscientiously fulfill their primary responsibility for biosafety, strictly implement China's relevant biosafety management requirements, and take effective biosafety measures for the transportation, storage, quarantine breeding, use, and disposal of inbound biological materials.
(3) If entry and exit of biological materials involve other regulatory requirements such as for special entry and exit goods or items, the relevant laws and regulations shall apply.

This announcement shall be implemented from December 30, 2025. In case of any inconsistency between the relevant provisions of the Announcement on Promoting the Pilot Experience of Beijing, Tianjin, Hebei, and Shanghai for Supervision of Inbound Biological Materials and Launching a New Round of Pilots (former AQSIQ Announcement No. 94 of 2017) and this announcement, this announcement shall prevail.

Attachments:

List of Risk Level Classification Scope and Corresponding Quarantine Supervision Measures for Inbound Biological Materials.xls
Application Form for Registration of Production, Processing, and Storage Units for Export Biological Materials.docx

General Administration of Customs
December 24, 2025

Official Document & Source

📎 [Download the Official PDF Document of This Announcement]

Source: General Administration of Customs of the People‘s Republic of China (GACC) / Announcement No. 2025-254 / Release Date: 2025-12-24 / Original Link: http://gdfs.customs.gov.cn/customs/302249/302266/302267/6910184/index.html

Note: The core content of this announcement, including the List of Risk Level Classification Scope and Corresponding Quarantine Supervision Measures for Inbound Biological Materials and the Application Form for Registration of Production, Processing, and Storage Units for Export Biological Materials, is available as downloadable attachments via the original link above and is crucial for determining specific procedures and requirements.

Regarding Document Language Versions and Our Services

Legal Validity: The “Official Chinese Text” section on this page is the only version with legal effect. Any decisions must be based on the official PDF document and its attachments you download above.
Professional Advice: The management of biological materials involves highly specific risk classifications, approval procedures, and biosafety responsibilities. We strongly advise you to provide the official documents to your professional customs broker or legal counsel for detailed guidance on compliance.
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Announcement of the General Administration of Customs No. 254 of 2025 (Announcement on Scientifically Improving Quarantine Supervision Measures for Entry and Exit Biological Materials)