Administrative Provisions of the People's Republic of China on Sanitary Quarantine for Special Goods and Articles Entering or Leaving the Territory of the People's Republic of China
Administrative Provisions of the People's Republic of China on Sanitary Quarantine for Special Goods and Articles Entering or Leaving the Territory of the People's Republic of China
Administrative Provisions of the People's Republic of China on Sanitary Quarantine for Special Goods and Articles Entering or Leaving the Territory of the People's Republic of China
Order of the General Administration of Customs No. 281
January 6, 2026
(Promulgated by Order of the General Administration of Customs No. 281 on January 6, 2026, and effective as of August 1, 2026)
Chapter I General Provisions
Article 1 These Provisions are formulated in accordance with the Frontier Health and Quarantine Law of the People's Republic of China and its implementation rules, the Biosecurity Law of the People's Republic of China, the Regulation on the Prevention and Treatment of HIV/AIDS, the Regulations on the Biosecurity Management of Pathogenic Microorganism Laboratories, and other relevant laws and administrative regulations, to regulate the supervision and administration of sanitary quarantine for special goods and articles entering or leaving the territory of the People's Republic of China (hereinafter referred to as the “territory”), prevent the cross-border transmission of infectious diseases, safeguard the life and health of the public, and prevent and address public health risks.
Article 2 These Provisions shall apply to the supervision and administration of sanitary quarantine for special goods and articles related to public health and safety, such as blood and other human tissues, pathogenic microorganisms, and biological products (excluding those subject to the regulatory regime for pharmaceuticals, veterinary drugs, or medical devices), that enter or leave the territory (hereinafter referred to as “inbound and outbound special goods and articles”).
Article 3 The General Administration of Customs (GAC) shall exercise nationwide unified administration over the supervision and administration of sanitary quarantine for inbound and outbound special goods and articles; the competent customs authorities shall be responsible for the supervision and administration of sanitary quarantine for inbound and outbound special goods and articles within their respective jurisdictions.
Article 4 The supervision and administration of sanitary quarantine for inbound and outbound special goods and articles shall be conducted in accordance with risk management principles, under which sanitary quarantine approval, quarantine inspection, and the supervision and administration thereof shall be applied on the basis of assessed risk levels.
The risk classifications of inbound and outbound special goods and articles, together with the corresponding sanitary quarantine regulatory measures, shall be dynamically adjusted and published by the GAC.
Article 5 High-risk special goods and articles entering the territory for the first time or resuming entry after a period of suspension shall be subject to sanitary quarantine access administration by the GAC. The specific requirements shall be separately formulated by the GAC.
Article 6 Entities with inbound or outbound special goods and articles, as well as the consignees, consignors, addressees, senders, carriers (transporters), bearers (carrying persons), or carriers of inbound or outbound special goods and articles, or their agents, shall import, export, produce, sell, and use such special goods and articles in accordance with laws and regulations and relevant standards, be responsible to society and the public, ensure their safety, accept public oversight, and assume social responsibility.
Chapter II Sanitary Quarantine Approval
Article 7 The customs authorities directly subordinate to GAC (hereinafter referred to as the “directly subordinated customs authorities”) shall be responsible for sanitary quarantine approval of inbound and outbound special goods and articles within their respective jurisdictions (hereinafter referred to as the “special goods and articles approval”).
Article 8 An application for special goods and articles approval shall meet the following conditions:
(1) Where approval documents from relevant authorities are required by laws or regulations, such approval documents have been obtained; and
(2) The applicant possesses biosecurity control capabilities commensurate with the inbound or outbound special goods and articles.
Article 9 Entities or natural persons with inbound or outbound special goods and articles (collectively referred to as “applicants”) shall apply for approval to the directly subordinated customs authority at the applicant's location prior to the shipment of the special goods and articles.
Article 10 An applicant applying for special goods and articles approval shall submit the following materials as required:
(1) An application form for special goods and articles approval;
(2) Descriptive materials for the inbound or outbound special goods and articles (including Chinese and English names, category, composition, source, production process, purpose, destination, exporting or importing country or region, producer, etc.), product safety certification materials, and a biosecurity risk self-assessment;
(3) Where the inbound or outbound special goods and articles contain or may contain pathogenic microorganisms, explanatory documents on the scientific names (in Chinese, English, or Latin) and biological characteristics of the pathogenic microorganisms (in both Chinese and English), as well as certification documents proving compliance with the corresponding level of biosecurity prevention and control shall be provided;
(4) For entities using inbound or outbound special goods and articles that contain or may contain pathogenic microorganisms, if pathogenic microorganism experimental activities are conducted in Level I or Level II laboratories, relevant laboratory record-filing materials filed with the health authority of the people's government at the level of a city divided into districts shall be provided; if such activities are conducted in Level III or Level IV laboratories, relevant certification documents for highly pathogenic microorganism experimental activities approved by the health authority of the people's government at or above the provincial level shall be provided; and
(5) For inbound or outbound highly pathogenic microorganism strains (toxins) or samples, transportation approval documents issued by the health authority of the people's government at or above the provincial level shall be provided.
Article 11 Where the applicant is an entity, when it applies for special goods and articles approval for the first time, it shall, in addition to the materials specified in Article 10 of these Provisions, submit the following materials as required by Customs:
(1) Basic information of the entity, such as its management system certification status, address, production premises, laboratory layout, warehousing facilities and equipment, product processing, production processes or workflows, and layout plans; and
(2) Certification materials proving biosecurity control capabilities.
Where the applicant is a natural person, identity documentation shall be provided.
For inbound or outbound special goods and articles that are pathogenic microorganisms or may contain pathogenic microorganisms, the applicant shall not be a natural person.
Article 12 A directly subordinated customs authority shall handle applications for special goods and articles approval in accordance with the following circumstances:
(1) If the matter under application does not require special goods and articles approval under the law, the applicant shall be informed immediately that the application will not be accepted;
(2) If the matter under application does not fall within its jurisdiction, he customs authority shall immediately make a decision of non-acceptance and inform the applicant to apply to another directly subordinated customs authority or the relevant administrative authority;
(3) If any errors in the application materials can be corrected on the spot, the applicant shall be allowed to correct them on the spot;
(4) If the application materials are incomplete or fail to meet statutory form requirements, the applicant shall be informed, on the spot or within five working days, in a single notice, of all materials that need to be supplemented or corrected; where the applicant is not informed within the prescribed time limit, the application shall be deemed accepted as of the date of receipt of the application materials; and
(5) Where the matter under application falls within its jurisdiction, if the application materials are complete and meet statutory form requirements, or if all required corrections or supplementations have been submitted, the application for administrative approval shall be accepted.
Article 13 Directly subordinated customs authorities shall examine the application materials and may verify them, depending on the circumstances, through expert document review, on-site assessment, or other means.
Article 14 Where an applicant's application meets statutory conditions and standards, the directly subordinated customs authority shall issue a special goods and articles approval certificate within 20 working days from the date of acceptance.
Where the application fails to meet statutory conditions or standards, the directly subordinate customs authority shall, within 20 working days from the date of acceptance, issue a written decision of non-approval stating the reasons and inform the applicant of its right to apply for administrative reconsideration or to initiate administrative litigation in accordance with law.
Where the directly subordinate customs authority is unable to make an approval or non-approval decision within 20 working days, it may, upon approval by the head of the authority, extend the time limit by 10 working days and shall inform the applicant of the reasons for the extension.
Article 15 The validity period of a special goods and articles approval certificate shall be determined based on risk conditions and shall not exceed 12 months.
Special goods and articles approval certificates shall be subject to cancellation administration by Customs.
Chapter III Quarantine Inspection
Article 16 The consignees, consignors, addressees, senders, or bearers (carrying persons) of inbound or outbound special goods and articles, or their agents, shall declare to Customs on the basis of the special goods and articles approval certificate and other required materials.
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Order of the General Administration of Customs No. 281
January 6, 2026
(Promulgated by Order of the General Administration of Customs No. 281 on January 6, 2026, and effective as of August 1, 2026)
Chapter I General Provisions
Article 1 These Provisions are formulated in accordance with the Frontier Health and Quarantine Law of the People's Republic of China and its implementation rules, the Biosecurity Law of the People's Republic of China, the Regulation on the Prevention and Treatment of HIV/AIDS, the Regulations on the Biosecurity Management of Pathogenic Microorganism Laboratories, and other relevant laws and administrative regulations, to regulate the supervision and administration of sanitary quarantine for special goods and articles entering or leaving the territory of the People's Republic of China (hereinafter referred to as the “territory”), prevent the cross-border transmission of infectious diseases, safeguard the life and health of the public, and prevent and address public health risks.
Article 2 These Provisions shall apply to the supervision and administration of sanitary quarantine for special goods and articles related to public health and safety, such as blood and other human tissues, pathogenic microorganisms, and biological products (excluding those subject to the regulatory regime for pharmaceuticals, veterinary drugs, or medical devices), that enter or leave the territory (hereinafter referred to as “inbound and outbound special goods and articles”).
Article 3 The General Administration of Customs (GAC) shall exercise nationwide unified administration over the supervision and administration of sanitary quarantine for inbound and outbound special goods and articles; the competent customs authorities shall be responsible for the supervision and administration of sanitary quarantine for inbound and outbound special goods and articles within their respective jurisdictions.
Article 4 The supervision and administration of sanitary quarantine for inbound and outbound special goods and articles shall be conducted in accordance with risk management principles, under which sanitary quarantine approval, quarantine inspection, and the supervision and administration thereof shall be applied on the basis of assessed risk levels.
The risk classifications of inbound and outbound special goods and articles, together with the corresponding sanitary quarantine regulatory measures, shall be dynamically adjusted and published by the GAC.
Article 5 High-risk special goods and articles entering the territory for the first time or resuming entry after a period of suspension shall be subject to sanitary quarantine access administration by the GAC. The specific requirements shall be separately formulated by the GAC.
Article 6 Entities with inbound or outbound special goods and articles, as well as the consignees, consignors, addressees, senders, carriers (transporters), bearers (carrying persons), or carriers of inbound or outbound special goods and articles, or their agents, shall import, export, produce, sell, and use such special goods and articles in accordance with laws and regulations and relevant standards, be responsible to society and the public, ensure their safety, accept public oversight, and assume social responsibility.
Chapter II Sanitary Quarantine Approval
Article 7 The customs authorities directly subordinate to GAC (hereinafter referred to as the “directly subordinated customs authorities”) shall be responsible for sanitary quarantine approval of inbound and outbound special goods and articles within their respective jurisdictions (hereinafter referred to as the “special goods and articles approval”).
Article 8 An application for special goods and articles approval shall meet the following conditions:
(1) Where approval documents from relevant authorities are required by laws or regulations, such approval documents have been obtained; and
(2) The applicant possesses biosecurity control capabilities commensurate with the inbound or outbound special goods and articles.
Article 9 Entities or natural persons with inbound or outbound special goods and articles (collectively referred to as “applicants”) shall apply for approval to the directly subordinated customs authority at the applicant's location prior to the shipment of the special goods and articles.
Article 10 An applicant applying for special goods and articles approval shall submit the following materials as required:
(1) An application form for special goods and articles approval;
(2) Descriptive materials for the inbound or outbound special goods and articles (including Chinese and English names, category, composition, source, production process, purpose, destination, exporting or importing country or region, producer, etc.), product safety certification materials, and a biosecurity risk self-assessment;
(3) Where the inbound or outbound special goods and articles contain or may contain pathogenic microorganisms, explanatory documents on the scientific names (in Chinese, English, or Latin) and biological characteristics of the pathogenic microorganisms (in both Chinese and English), as well as certification documents proving compliance with the corresponding level of biosecurity prevention and control shall be provided;
(4) For entities using inbound or outbound special goods and articles that contain or may contain pathogenic microorganisms, if pathogenic microorganism experimental activities are conducted in Level I or Level II laboratories, relevant laboratory record-filing materials filed with the health authority of the people's government at the level of a city divided into districts shall be provided; if such activities are conducted in Level III or Level IV laboratories, relevant certification documents for highly pathogenic microorganism experimental activities approved by the health authority of the people's government at or above the provincial level shall be provided; and
(5) For inbound or outbound highly pathogenic microorganism strains (toxins) or samples, transportation approval documents issued by the health authority of the people's government at or above the provincial level shall be provided.
Article 11 Where the applicant is an entity, when it applies for special goods and articles approval for the first time, it shall, in addition to the materials specified in Article 10 of these Provisions, submit the following materials as required by Customs:
(1) Basic information of the entity, such as its management system certification status, address, production premises, laboratory layout, warehousing facilities and equipment, product processing, production processes or workflows, and layout plans; and
(2) Certification materials proving biosecurity control capabilities.
Where the applicant is a natural person, identity documentation shall be provided.
For inbound or outbound special goods and articles that are pathogenic microorganisms or may contain pathogenic microorganisms, the applicant shall not be a natural person.
Article 12 A directly subordinated customs authority shall handle applications for special goods and articles approval in accordance with the following circumstances:
(1) If the matter under application does not require special goods and articles approval under the law, the applicant shall be informed immediately that the application will not be accepted;
(2) If the matter under application does not fall within its jurisdiction, he customs authority shall immediately make a decision of non-acceptance and inform the applicant to apply to another directly subordinated customs authority or the relevant administrative authority;
(3) If any errors in the application materials can be corrected on the spot, the applicant shall be allowed to correct them on the spot;
(4) If the application materials are incomplete or fail to meet statutory form requirements, the applicant shall be informed, on the spot or within five working days, in a single notice, of all materials that need to be supplemented or corrected; where the applicant is not informed within the prescribed time limit, the application shall be deemed accepted as of the date of receipt of the application materials; and
(5) Where the matter under application falls within its jurisdiction, if the application materials are complete and meet statutory form requirements, or if all required corrections or supplementations have been submitted, the application for administrative approval shall be accepted.
Article 13 Directly subordinated customs authorities shall examine the application materials and may verify them, depending on the circumstances, through expert document review, on-site assessment, or other means.
Article 14 Where an applicant's application meets statutory conditions and standards, the directly subordinated customs authority shall issue a special goods and articles approval certificate within 20 working days from the date of acceptance.
Where the application fails to meet statutory conditions or standards, the directly subordinate customs authority shall, within 20 working days from the date of acceptance, issue a written decision of non-approval stating the reasons and inform the applicant of its right to apply for administrative reconsideration or to initiate administrative litigation in accordance with law.
Where the directly subordinate customs authority is unable to make an approval or non-approval decision within 20 working days, it may, upon approval by the head of the authority, extend the time limit by 10 working days and shall inform the applicant of the reasons for the extension.
Article 15 The validity period of a special goods and articles approval certificate shall be determined based on risk conditions and shall not exceed 12 months.
Special goods and articles approval certificates shall be subject to cancellation administration by Customs.
Chapter III Quarantine Inspection
Article 16 The consignees, consignors, addressees, senders, or bearers (carrying persons) of inbound or outbound special goods and articles, or their agents, shall declare to Customs on the basis of the special goods and articles approval certificate and other required materials.
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