To implement General Secretary Xi Jinping's important directives and instructions on strengthening biosecurity at the borders and to strictly fulfill customs responsibilities under the Frontier Health and Quarantine Law of the People's Republic of China (hereinafter referred to as the Frontier Health and Quarantine Law) and the Biosecurity Law of the People's Republic of China (hereinafter referred to as the Biosecurity Law), the General Administration of Customs (GACC) has revised the Regulations on Sanitary Quarantine Management of Special Goods and Items Entering and Leaving the Country in order to prevent and address biosecurity risks associated with the import and export of special goods and articles. On January 6, 2026, the GACC issued the Regulations of the People's Republic of China on Sanitary Quarantine Management of Special Goods and Items Entering and Leaving the Country (Order No. 281 of the GACC), effective from August 1, 2026. To ensure that administrative counterparties and all sectors of society comprehensively understand and accurately grasp the background and key provisions of this regulatory revision, the following interpretation is provided:
I. Background and Purpose of the Revision
The Regulations on Sanitary Quarantine Management of Special Goods and Items Entering and Leaving the Country, which took effect on March 1, 2015, have played a vital role in standardizing supervisory and administrative management of health and quarantine inspection for special goods and articles entering and leaving the country, preventing the introduction and spread of infectious diseases, controlling biosecurity risks, and protecting public health. However, with the revision and implementation of the Frontier Health and Quarantine Law and the acceleration of China's biopharmaceutical industry internationalization, customs requirements for health and quarantine inspection of special goods and articles entering and leaving the country have increased significantly with regard to coordinating development and security. Accordingly, the Regulations on Sanitary Quarantine Management of Special Goods and Items Entering and Leaving the Country require corresponding revision.
II. Key Issues Requiring Clarification
(1) Alignment with the requirements of the newly revised Frontier Health and Quarantine Law and other higher-level laws.
First, in accordance with the Frontier Health and Quarantine Law, the term "special articles" has been amended to "special goods and articles," aligning with provisions in the Frontier Health and Quarantine Law concerning "goods and articles related to public health security." The scope of application of the regulations has been adjusted such that pharmaceutical products, veterinary drugs, and medical devices subject to separate regulatory management shall no longer be subject to supervision as special goods and articles (Article 2). The declarant has been clarified as "the consignor, consignee, courier, carrier (person carrying), or their agent of special goods and articles entering and leaving the country" (Article 16). A new provision has been added establishing that "customs shall conduct biosecurity risk monitoring of inbound and outbound special goods and articles that may pose threats to domestic public health security" (Article 21). Second, in accordance with the Biosecurity Law, a new admission system for health and quarantine inspection of high-risk special goods and articles has been introduced (Article 5); for import of highly pathogenic microorganisms posing extreme safety risks, a new provision requiring notification to the competent health authorities has been added (Article 17, Paragraph 3).
(2) Reinforcement of risk management principles.
First, risk management principles have been integrated throughout the entire process of supervising special goods and articles. Drawing on international biosecurity risk management practices, the application materials for approval of special goods and articles now include biosecurity-related items such as "production process," "product safety certification materials," and "self-assessment of biosecurity risks" (Article 10). Second, "detention" has been replaced with "temporary non-release," and considering that temporary non-release of special goods and articles through postal channels presents significant biosecurity risks, the provision permitting temporary non-release through postal channels has been deleted (Article 18). Third, aligned with the focus of sanitary quarantine risk management, the circumstances requiring return shipment or destruction now include the item "production facility," which is closely related to biosecurity risks of special goods and articles (Article 19).
(3) Consolidation of well-established practical experience.
First, the restrictions on customs declaration at ports of entry and at the location of outbound special goods and articles have been removed, and new provisions regarding pre-export declaration supervision have been added (Article 16). The handling of anomalies in inspection and supervisory management has been adjusted from "the port customs authority issues a 'Notification of Inspection and Quarantine Disposition' and arranges for return shipment or destruction" to "arrange for return shipment or destruction in accordance with law and accept customs supervision," thereby clarifying the primary responsibility of enterprises for the biosecurity of special goods and articles (Articles 19 and 22). Second, since environmental protection microbial inoculants are no longer regulated as special goods and articles, provisions related to laboratory testing have been deleted in accordance with operational requirements.
(Contributed by: Department of Policy and Legal Affairs, Department of Health and Quarantine)
Disclaimer：The above content is translated from Chinese version of GACC. The GACC version shall prevail.
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