In the AI Era: Streamlining Special Goods Approvals with Intelligent Systems

 

 

To foster the growth of new quality productive forces in China's biomedical industry and in accordance with the principles of risk-based tiered management for special goods, the General Administration of Customs has introduced an "Intelligent Approval" policy for the entry and exithealth quarantine on low-risk special goods (as announced in the Notice Bulletin of the "Approval and Analysis System for Entry-exit Health Quarantine on Special Goods"). The key details are outlined below:

I. Scope of Application

The "Intelligent Approval" mechanism applies to low-risk special goods classified as C2 in the Table on Biosecurity Risk Grading and Supervision of Entry and Exit Special Articles. (Remark: This policy does not disrupt existing administrative licensing procedures. Applicants may opt to use "Intelligent Approval" based on their specific needs.)

II. Eligibility for Applicants

1. All applicants must meet the requisite conditions for obtaining health quarantine approval for cross-border special goods.

2. The "Intelligent Approval" mechanism is not available to individual (natural person) applicants.

III. Implementation Process

(I) Signing the Commitment Letterfor “Intelligent Approval”

Upon their initial application for “Intelligent Approval”, applicants are required to sign theCommitment Letter Regarding Biosafety Responsibilities for Low-risk Special Goods under the Intelligent Approval Scheme.

(II) Submitting Information of Special Goodsfor “Intelligent Approval”

Applicants must enter the required details of the special goods in the designated “Intelligent Approval” module, upload all relevant supporting documents, and request a review of the information for their special goods under the “Intelligent Approval” track. For antibody-based products within the category of biologicals, applicants may follow the protocolset within the approval system for a standardized declaration.

(III) Finalizing Application for “Intelligent Approval”

For special goods that have received the "Intelligent Approval" status, applicants are eligible to apply under this scheme. The approval system will automatically verify the status and generate the entry and exit health quarantine clearance form for such special goods.

(IV) Grounds for Suspensionof “Intelligent Approval”

An applicant may be suspended from the “Intelligent Approval” mechanism should Customs authority identify any of the following:

1. The applicant has submitted false, altered, forged, or concealed documentation, or any other non-compliant materials, related to the special goods declared under the “Intelligent Approval”scheme.

2. The applicant commits fraudulent declaration (including falsification or concealment) or any other violation in the course of importing or exporting special goods.

3. Any change to the applicant’s biosafety control system results in its failure to meet the requirements of the “Intelligent Approval”scheme.

4. Any other material legal or regulatory violation is discovered, or the supervising Customs authority deems suspension necessary.

(V) Procedure for Reinstatementof “Intelligent Approval”

A listed applicant whose “Intelligent Approval” access has been suspended and seeking to have it restored must submit the Application for Restoration of “Intelligent Approval” for Low-Risk Special Goods” together with supporting evidence demonstrating the implementation of corrective measures. If required by Customs, the applicant should undergo and pass an on-site compliance assessment. The “Intelligent Approval” eligibility will be reinstated upon successful completion of this process.

IV. Key Provisions

(I) Adherence to Primary Biosafety Responsibility

Applicants bear the primary responsibility, both as the regulated party in the administrative approval process and for biosafety prevention and control. Full and accurate declaration of all information regarding the special goods is required. Furthermore,applicants must also fulfill all applicable biosafety management requirements.

(II) Providing Feedback on Issues with the “Intelligent Approval” Mechanism

When using the “Intelligent Approval” mechanism, applicants should report any issues encountered to their local competent Customs authority. Such feedback is crucial for the ongoing refinement of the policy and system, thereby safeguarding the smooth operation of the“Intelligent Approval” initiative.

 

 

---