Regulations on Health and Quarantine Management of Special Goods for Import and Export by the Customs of the People's Republic of China (General Administration of Customs Order No. 281)
(Announced by Order No. 281 of the General Administration of Customs on January 6, 2026, effective from August 1, 2026)
Chapter 1 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 Biosafety Law of the People's Republic of China, the Regulation on the Prevention and Control of AIDS, the Regulation on the Biosafety of Pathogenic Microorganism Laboratories and other laws and administrative regulations in order to standardize the supervision and management of health quarantine of entry and exit special goods and articles, prevent the cross-border spread of infectious diseases, safeguard public life safety and health, and prevent and resolve public health risks.
Article 2: These regulations apply to the supervision and management of health quarantine for special goods and items related to public health and safety, such as blood and other human tissues, pathogenic microorganisms, biological products, etc. (excluding those included in the management of drugs, veterinary drugs, and medical devices) entering and leaving the country.
Article 3: The General Administration of Customs shall unify the management of health and quarantine supervision and management of special goods and articles entering and leaving the country; The competent customs is responsible for the supervision and management of health and quarantine of special goods and items entering and leaving the area under its jurisdiction.
Article 4: The health and quarantine supervision and management of special goods and articles entering and leaving the country shall follow the principle of risk management, and implement health and quarantine approval, quarantine inspection, and supervision and management based on risk assessment and risk level.
The risk levels and corresponding health and quarantine supervision methods for special goods and items entering and leaving the country shall be dynamically adjusted and announced by the General Administration of Customs.
Article 5: The General Administration of Customs shall implement health quarantine access management for high-risk special goods and articles that enter for the first time or resume entry after suspension. Specific requirements shall be separately formulated by the General Administration of Customs.
Article 6: Units of special goods and items entering and leaving the country, as well as the consignees, senders, carriers, or their agents of special goods and items entering and leaving the country, shall, in accordance with the requirements of laws, regulations, and relevant standards, import, export, produce, sell, and use special goods and items, be responsible to society and the public, ensure the safety of special goods and items, accept social supervision, and assume social responsibility.
Chapter 2 Health Quarantine Approval
Article 7: The directly affiliated customs shall be responsible for the health and quarantine approval of special goods and articles entering and leaving the jurisdiction (hereinafter referred to as the approval of special goods and articles).
Article 8: The following conditions shall be met for the approval of special goods and items:
（1） If laws and regulations require approval documents from relevant departments, corresponding approval documents should be obtained;
（2） Capable of biosafety control that is compatible with special goods and items entering and exiting the country.
Article 9: Units or natural persons (hereinafter referred to as applicants) that import or export special goods or items shall apply for approval from the customs directly under the applicant's jurisdiction before the special goods or items are shipped.
Article 10: For applications for approval of special goods or items, the applicant shall provide the following corresponding materials in accordance with regulations:
（1） Application Form for Approval of Special Goods and Items;
（2） Descriptive materials for special goods and items entering and leaving the country (including Chinese and English names, categories, ingredients, sources, production processes, uses, flow directions, countries or regions of export and import, manufacturers, etc.), product safety certification materials, self-assessment of biological safety risks, etc;
（3） If special goods or items entering or leaving the country contain or may contain pathogenic microorganisms, the scientific name (in Chinese, English, or Latin) of the pathogenic microorganisms, explanatory documents of their biological characteristics (in both Chinese and English), and proof of corresponding biosafety prevention and control levels should be provided;
（4） Units using special goods or items that contain or may contain pathogenic microorganisms for import and export, and conducting pathogenic microorganism experiments in first - and second level pathogenic microorganism laboratories, shall provide laboratory registration materials filed with the health department of the people's government at the city level where the district is located; If the experimental activities of pathogenic microorganisms are carried out in third or fourth level pathogenic microorganism laboratories, relevant certification documents for highly pathogenic pathogenic microorganism experimental activities approved by the health department of the people's government at or above the provincial level shall be provided;
（5） For the entry and exit of highly pathogenic microorganisms (viruses) or samples, relevant transportation certification materials approved by the health department of the people's government at or above the provincial level shall be provided.
Article 11: If the applicant is a unit, when applying for approval of special goods or articles for the first time, in addition to the materials listed in Article 10 of these regulations, the following materials shall also be provided according to customs requirements:
（1） Basic information of the unit, such as the certification status of the unit's management system, unit address, production site, laboratory settings, storage facilities and equipment, product processing status, production process or process flow, floor plan, etc;
（2） Proof of biological safety control capability.
If the applicant is a natural person, they shall provide identification documents.
The applicant for the import and export of pathogenic microorganisms or special goods or items that may contain pathogenic microorganisms shall not be a natural person.
Article 12: The directly affiliated customs shall handle the special goods and articles approval application submitted by the applicant according to the following situations:
（1） If the application does not require approval for special goods or items according to law, the applicant shall be immediately informed that it will not be accepted;
（2） If the application does not fall within the scope of the Customs' authority according to law, a decision shall be made immediately to reject it, and the applicant shall be informed to apply to other directly affiliated Customs or relevant administrative agencies;
（3） If there are errors in the application materials that can be corrected on the spot, the applicant should be allowed to correct them on the spot;
（4） If the application materials are incomplete or do not conform to the legal form, the applicant shall be informed of all the content that needs to be supplemented on the spot or within five working days. If the applicant fails to inform within the time limit, the application shall be accepted from the date of receipt of the application materials;
（5） If the application falls within the scope of the authority of this Customs, and the application materials are complete and in accordance with the statutory form, or if the applicant submits all the supplementary application materials as required by this Customs, the administrative license application shall be accepted.
Article 13: The directly affiliated customs shall review the application materials. According to the situation, the application materials can be verified through expert data review, on-site evaluation, and other methods.
Article 14: If the applicant's application meets the statutory conditions and standards, the directly affiliated customs shall issue a special goods and articles approval form within 20 working days from the date of acceptance.
If the applicant's application does not meet the statutory conditions and standards, the directly affiliated customs shall make a written decision not to approve it within 20 working days from the date of acceptance, explain the reasons, and inform the applicant of their right to apply for administrative reconsideration or file an administrative lawsuit in accordance with the law.
If the directly affiliated customs cannot make an approval or refusal decision within 20 working days, with the approval of the responsible person of this customs, it may be extended for 10 working days, and the reasons for the extension shall be notified to the applicant.
Article 15: The validity period of the approval form for special goods and items shall be determined based on the risk situation, and shall not exceed twelve months at most.
Customs implements verification management on approval forms for special goods and items.
Chapter 3 Quarantine Inspection
Article 16: The consignees, senders, carriers (carriers) or their agents of special goods and items entering or leaving the country shall declare to the customs with the approval form for special goods and items and other materials. Customs compares and verifies documents such as approval forms for special goods and items. If the declaration materials are incomplete or do not comply with the legal form, the customs will not allow entry or exit.
Special goods and items that need to be exported shall apply for quarantine to the customs at the place of production or the location of the applicant.
Article 17 Customs shall conduct quarantine inspection on special goods and articles entering and leaving the country in accordance with the following requirements, and fill in quarantine inspection records:
（1） Verify whether the import and export special goods, item names, ingredients, batch numbers, specifications, quantities, expiration dates, transportation and storage conditions, export/import countries, and production units match the contents of the special goods and item approval form;
（2） Check whether the packaging of special goods and items entering and leaving the country is safe and undamaged, without leakage or seepage, and whether those with biological safety risks have biological safety labels that meet relevant requirements.
If the inspection site at the entry port does not have the necessary safety protection conditions for quarantine inspection of special goods and items, the special goods and items shall be transported to designated places that meet the conditions for quarantine inspection.
For imported special goods and items containing highly pathogenic microorganisms, the customs directly under the destination shall promptly notify the health authority of the unit using the special goods and items.
Article 18: If special goods or items are carried in or out of the country without obtaining an approval form, the customs will temporarily refuse to release them and issue relevant certificates.
After the carrier obtains the approval form for special goods and items within seven days, the customs shall carry out quarantine inspection in accordance with Article 17 of these regulations. Those who pass the quarantine inspection shall be released.
Article 19: Customs shall release special goods and items that have passed quarantine inspection for entry and exit. In any of the following circumstances, special goods and items for export shall not be allowed to leave the country, and special goods and items for import shall be returned or destroyed in accordance with the law and subject to customs supervision:
（1） Names, batch numbers, bioactive ingredients, specifications, and production units that do not match the content of the approval form for special goods or items;
（2） Failure to obtain approval documents for special goods or items, or exceeding the approved quantity range for special goods or items;
（3） Packaging that does not meet the safety management requirements for special goods and items;
（4） Other situations where the quarantine inspection fails.
For imported special goods and items that may pose public health risks due to packaging damage, leakage, etc., they shall be destroyed in accordance with the law and subject to customs supervision.
Chapter 4 Supervision and Management
Article 20: Units that import and export special goods and items shall establish a biosafety management system for special goods and items, and strictly produce, sell, and use special goods and items in accordance with the approved purposes.
Units that import and export special goods and items shall establish records of the production, sales, and use of special goods and items. The records should be truthful and the retention period should not be less than three years.
Article 21: Customs shall conduct biosafety risk monitoring on special goods and items that may pose a threat to public health and safety within the country.
For special goods and items that need to be sampled for testing in order to implement risk monitoring, the units responsible for collecting and testing special goods and items shall cooperate with the customs requirements to carry out sample collection work.
Article 22: The customs shall supervise and manage the production, sales, and use of special goods and items units entering and leaving the country based on the approval form for special goods and items.
If any of the following situations are found during the supervision and management process, they shall be returned or destroyed in accordance with the law and subject to customs supervision:
（1） If the laboratory using special goods or items is inconsistent with the approval form for special goods or items, except with the consent of the customs;
（2） If there is a discrepancy between the goods certificate and the approval form for imported special goods or items.
Article 23 Customs personnel shall enforce the law impartially and be loyal to their duties. In the performance of their duties, they shall have the obligation to keep confidential any trade secrets, personal privacy, and personal information they come across.
Chapter 5 Legal Liability
Article 24: Anyone who violates these regulations and falls under any of the following circumstances shall be fined up to 100000 yuan by the customs:
（1） Obtaining approval forms for special goods or items through deception, bribery, or other improper means;
（2） Selling or using special goods or items without the consent of the customs;
（3） Failure to return or destroy special goods or items in accordance with the requirements of these regulations;
（4） Not conducting operations on special goods or items in the corresponding biosafety level laboratory;
（5） Failure to establish records of the production, sale, and use of special goods or items, or records that do not match the actual situation.
Article 25: Those who violate these regulations by refusing or obstructing customs and their staff from performing their duties in accordance with the law shall be transferred to relevant departments for handling in accordance with the law.
Article 26: Customs personnel who engage in favoritism, abuse of power, neglect of duty, and violate relevant laws and regulations shall be subject to disciplinary action in accordance with the law; If the circumstances are serious enough to constitute a crime, criminal responsibility shall be pursued in accordance with the law.
Article 27: Those who violate these regulations and commit crimes shall be held criminally responsible in accordance with the law.
Chapter 6 Supplementary Provisions
Article 28: The meanings of the following terms in these regulations:
Blood and other human tissues refer to whole blood, plasma, serum, other blood components, cells, cell lines, embryos, organs, tissues, bone marrow, as well as other secretions, excretions, and body fluids that may transmit infectious diseases, such as cerebrospinal fluid, pleural fluid, and peritoneal fluid.
Pathogenic microorganisms refer to microorganisms that can invade the human body, causing infections and even infectious diseases, including viruses, bacteria, fungi, actinomycetes, rickettsia, spirochetes, chlamydia, mycoplasma, prions, parasites, etc.
Biological products refer to biologically active agents such as proteins, cytokines, enzymes and their preparations, toxins, antigens, antibodies, antigen antibody complexes, nucleic acids, and other biotechnology products derived from humans or used in human medical related fields.
Special goods and items units for import and export refer to legal persons or other organizations engaged in the production, sales, and use of special goods and items for import and export (including scientific research, medical treatment, inspection, pharmaceutical research and development outsourcing, etc.).
Article 29: If special goods or items entering or leaving the country involve other regulatory requirements such as animal and plant quarantine, they shall be handled in accordance with relevant laws and regulations.
Article 30: These regulations shall be interpreted by the General Administration of Customs.
Article 31: These regulations shall come into effect on August 1, 2026. On January 21, 2015, the original General Administration of Quality Supervision, Inspection and Quarantine Order No. 160 was announced, and the "Regulations on Health and Quarantine Management of Entry Exit Special Goods" revised according to the original General Administration of Quality Supervision, Inspection and Quarantine Order No. 184 on October 18, 2016, General Administration of Customs Order No. 238 on April 28, 2018, General Administration of Customs Order No. 240 on May 29, 2018, and General Administration of Customs Order No. 243 on November 23, 2018 were simultaneously abolished.