From Declaration to Clearance: A Detailed Guide to Chinese Pharmaceutical Export Processes and Regulations

From Declaration to Clearance: A Detailed Guide to Chinese Pharmaceutical Export Processes and Regulations

The declaration and customs clearance stages of pharmaceutical exports are the “last mile” connecting domestic production to the international market and a focal point for compliance risks. These stages involve oversight from multiple regulatory bodies, including the National Medical Products Administration (NMPA), the General Administration of Customs (GAC), and the State Taxation Administration. They require strict adherence to a series of regulations such as the Drug Administration Law, the Customs Law, and the Regulations on the Management of Drug Export Sales Certificates. If Chinese pharmaceutical companies fail to master the procedural details and fully understand regulatory requirements, they are highly susceptible to issues such as flawed declaration materials, failed inspections, clearance delays, and even face cargo seizures and administrative penalties. This article, centered on “Process Breakdown + Regulation Alignment + Practical Skills,” provides a detailed analysis of the end-to-end operational chain from declaration to clearance for drug exports, aiming to clear compliance hurdles for enterprises.

I. Pre-Export Preparation: Compliance Foundation and Document Assembly (The Critical Pre-Process Phase)

Before initiating the declaration process, companies must complete compliance qualification verification, target market policy alignment, and document preparation. This is the prerequisite for ensuring smooth subsequent declaration and clearance.

(1) Core Compliance Qualification Requirements

• Enterprise Qualification: The manufacturing enterprise must hold a valid Drug Manufacturing License with a production scope covering the export drug category. A trading enterprise must obtain a Drug Business License with a business scope that includes “drug import and export.” If using a third-party agent, the agent must possess pharmaceutical import/export operation qualifications and customs brokerage qualifications. A formal agency agreement must be signed, clearly defining the rights and obligations of both parties.
• Product Compliance Qualifications:
  • Essential Documents: Drug Export Sales Certificate (valid for 3 years, applied for in WHO 2021 format, processed by provincial NMPA within 20 working days), GMP Compliance Certificate (if required by the target market, such as PIC/S GMP or Chinese GMP certification documents).
  • Supplementary Qualifications: For Active Pharmaceutical Ingredients (APIs), exporting to the EU requires a Certificate of a Pharmaceutical Product for the Export of APIs to the EU (CEP Certificate), while exporting to the US requires FDA DMF registration. For special categories like vaccines and biologics, a special export license issued by the NMPA is additionally required.
• Target Market Access Qualifications: Obtain the importing country’s market access documents in advance, such as US FDA registration certificates, EU EMA marketing authorizations, Australian ARTG inclusion certificates, etc. For products procured by international organizations (e.g., WHO-prequalified, MPP-authorized), provide procurement authorization documents and relevant supporting materials.

(2) Standardized Preparation of Declaration Documents
Declaration documents must adhere to the principles of “Completeness, Accuracy, and Consistency.” The core categories, which must be compiled and archived according to Customs’ required format, include:

• Qualification Certificates:
  • Enterprise Qualifications: Copies of Drug Manufacturing License and Drug Business License (with company seal), agency export agreement (if applicable).
  • Product Qualifications: Original and copy of Drug Export Sales Certificate, copies of target market access certificates, GMP certification, quality standards (must comply with both Chinese Pharmacopoeia and importing country pharmacopoeia requirements).
  • Special Documents: For traditional Chinese medicine products containing endangered animal/plant ingredients, a CITES export permit is required. For poisonous drugs for medical use, a provincial NMPA Poisonous Drug Export Approval Form is needed.
• Commercial/Trade Documents:
  • Commercial Invoice: Must state drug name, strength, batch number, quantity, unit price, total value, and trade terms (e.g., FOB, CIF). The value must match the customs declaration form.
  • Packing List: Details the name, strength, batch number, quantity, gross weight, net weight, and carton number for each box. Mixed shipments of multiple categories must be clearly demarcated.
  • Certificate of Origin: To enjoy tariff reduction under Free Trade Agreements (e.g., RCEP, China-Australia FTA), Form A or FTA-specific Certificates of Origin must be obtained in advance, clearly stating China as the country of origin.
• Quality Testing and Traceability Documents:
  • Certificate of Analysis (CoA) for each batch, containing key indicators like description, identification, tests, and assay. Must be issued by the enterprise’s quality control department or a qualified third-party authority.
  • Drug traceability code information sheet, linking production, testing, and release information, ensuring customs can query full-process data via the code.
  • For cold chain drugs, additional documents include a transport condition assessment and data logger calibration certificate.
• Declaration-Specific Documents:
  • Customs Declaration Form: Filed via the “Single Window” system. Requires accurate completion of HS code and declaration elements (e.g., drug name, composition, use, strength, manufacturer).
  • Declaration Elements Explanation: For complex categories (e.g., compound preparations, biologics), supplementary explanatory materials on composition, pharmacological action, and clinical use may be needed to avoid HS code misclassification.

(3) Key Points for Aligning with Target Market Regulations
Different countries/regions have varying requirements for declaration documents. Preemptive adaptation is crucial:

• Exporting to the EU: Requires English versions of labeling/package inserts, copy of CEP Certificate, and an Importer’s Responsibility Statement.
• Exporting to the US: The declaration form must note the FDA registration number (FEI) and NDC code. Accompany with an FDA Release Notice if applicable.
• Exporting to Southeast Asia: Requires quality certificates in the local language. Some countries (e.g., Vietnam, Thailand) additionally require translated and notarized copies of the package insert.
• Exporting to the Middle East: Must comply with religious禁忌-related requirements (e.g., clearly stating alcohol content; obtaining prior import country permission for porcine-derived ingredients).

II. Declaration and Filing Process: From System Submission to Approval (Core Operational Phase)
Pharmaceutical export declaration involves two major steps: “Filing with Domestic Regulatory Authorities” and “Customs Declaration,” which must strictly follow system operation norms and timeline requirements.

(1) Filing with Domestic Regulatory Authorities (Mandatory Pre-Export Requirement)

• Application for Drug Export Sales Certificate:
  • Application Path: Online submission via the provincial NMPA’s “Drug Regulatory Information System,” uploading the Drug Export Sales Certificate Application Form, GMP compliance proof, manufacturing process description, quality standards, etc.
  • Review Focus: Provincial NMPA focuses on verifying consistency between production scope and export category, GMP compliance, and document completeness. Upon approval, an electronic or paper certificate is issued. The certificate number must be included in the customs declaration.
  • Note: Drugs not marketed domestically can also apply; domestic marketing approval is not required. The certificate is valid for 3 years. Renewal should be applied for before expiry to avoid gaps.
• Filing of Export Drug File:
  • As per the Regulations for the Inspection of Drug Exporting Manufacturers and the Management of Export Certificates, an export drug file must be established in the regulatory information system, reporting production/sales data, quality standards, labeling, etc.
  • Annual production/sales data for the previous year must be updated by April 30th to ensure file information matches actual exports.
  • The file content should cover differentiated requirements of various importing countries, such as different labeling norms and quality standard variations.
• Special Filing for Controlled Drugs:
  • Class II Psychotropic Substances: Require application to the NMPA for a Psychotropic Substances Export Permit, submitting the importing country’s official import permit, export contract, etc. The approval timeline is 20 working days.
  • Poisonous Drugs for Medical Use: Application to the provincial NMPA for a Poisonous Drug Export Approval Form, requiring the importing country’s health department import permit for toxic drugs.
  • Narcotic Drugs: Only permitted for international emergency medical aid, requiring dual authorization from the NMPA and relevant UN agencies.

(2) Customs Declaration Process (The Core Clearance Phase)

• Customs Declaration Form Submission:
  • Submission Platform: Online via “China International Trade Single Window” or “Internet + Customs” platform, supporting paperless declaration (fully implemented in some regions).
  • Key Fields:
    • HS Code: Accurate classification per the Customs Import and Export Tariff of the People’s Republic of China. APIs mainly fall under Chapter 29, finished dosage forms under Chapter 30. Misclassification can lead to incorrect duty rates or non-compliance with regulatory requirements.
    • Declaration Elements: Truthfully declare core elements such as “name, composition, use, strength, manufacturer, Drug Export Sales Certificate number, target market access certificate number.” Omission or false declaration is prohibited.
    • Tax Information: Specify applicable duty and VAT rates. If eligible for tariff reduction, note the Certificate of Origin number and corresponding FTA code on the declaration form.
• Electronic and Manual Review:
  • Electronic Review: The Customs system automatically cross-checks declaration information against regulatory databases, verifying document validity and consistency. If no anomalies are found, approval is typically completed within 1-3 working days.
  • Manual Review: If the system flags a “risk alert” (e.g., sensitive category, vague declaration elements, abnormal price), the case is transferred for manual review. Customs officers will scrutinize the authenticity and compliance of the documents and may request supplementary explanations.
• Tax Payment:
  • Upon approval, Customs issues an electronic tax payment notice. Enterprises must pay applicable duties and VAT within the stipulated period (generally 15 working days) via bank transfer or online payment.
  • If eligible for tariff reduction, ensure supporting documents like the Certificate of Origin have passed Customs verification to avoid losing the benefit due to document flaws.
  • Late payment incurs a daily surcharge of 0.05% of the overdue tax amount.

III. Customs Inspection: Process, Focus Areas, and Response Techniques (Key Risk Control Phase)
Customs inspection is an inevitable part of pharmaceutical export clearance, categorized into routine and targeted inspections. Enterprises must prepare in advance and cooperate actively.

(1) Inspection Process and Triggers

• Inspection Process: After approval, Customs determines inspection based on risk level. Inspection typically occurs at port/airport Customs supervision areas. The process includes:
  • Enterprise Notification: Customs notifies the enterprise via the “Single Window” or phone, specifying the time, location, and required cooperation.
  • On-site Inspection: Officers verify consistency between goods and documents, checking drug packaging, labeling, batch numbers, quantity, etc. Sampling for testing may be conducted if necessary.
  • Result Determination: If compliant, a Notice of Qualified Inspection is issued. If non-compliant, measures like seizure, return, or destruction are taken as per regulations.
• Common Triggers for Inspection:
  • High-Risk Category: Drugs are high-risk regulated goods, especially APIs, psychotropics, and cold chain drugs, with significantly higher inspection rates than ordinary goods.
  • Declaration Anomalies: Vague declaration elements, questionable HS code classification, price deviating from reasonable market range, inconsistent document information.
  • Policy Requirements: Customs launches special campaigns (e.g., against counterfeit drugs, sensitive drug smuggling), expanding inspection scope.
  • Low Enterprise Credit Rating: Enterprises on Customs’ “Dishonest Entity List” face substantially higher inspection rates.

(2) Key Inspection Focus Areas
Inspections focus on “Compliance, Authenticity, and Safety,” emphasizing:

• Document Consistency Verification:
  • Cross-checking drug name, strength, batch number, quantity, and value across the declaration form, commercial invoice, packing list, and Drug Export Sales Certificate for exact match.
  • Verifying that labeling/package inserts comply with Chinese and target market requirements, containing core information (generic name, batch number, expiry date, manufacturer).
  • Confirming the CoA corresponds to the batch number of the goods and that test results meet quality standards.
• Physical Goods Verification:
  • Checking drug packaging integrity for damage, leakage, or moisture. For cold chain drugs, verifying insulation packaging meets requirements.
  • Verifying batch numbers and expiry dates on goods match the declaration. Checking for mixed shipments of expired or near-expiry drugs.
  • Sampling for Testing: For suspected quality issues, Customs samples goods for lab testing of components, impurities, microorganisms, etc. Testing typically takes 7-15 working days.
• Compliance Qualification Verification:
  • Verifying the validity of the enterprise’s Drug Manufacturing License or Drug Business License and whether the production/business scope covers the export category.
  • Checking the authenticity and validity of documents like the Drug Export Sales Certificate and Psychotropic Substances Export Permit for forgery or alteration.
  • Verifying logistics provider qualifications, ensuring they possess compliant drug transport licenses. For cold chain, checking temperature records for completeness and compliance.

(3) Inspection Response Techniques

• Advance Preparation:
  • Designate a product-knowledgeable person to handle inspection, carrying complete copies of declaration documents, product descriptions, and quality standards for quick officer reference.
  • Pre-organize goods to ensure intact packaging and clear labeling. Arrange by batch number and category for easy officer counting.
  • For cold chain drugs, prepare temperature/humidity recording reports in advance to prove transport compliance.
• On-site Cooperation:
  • Answer officers’ questions truthfully without concealment or misrepresentation. Explain any queries professionally and concisely.
  • Provide supplementary materials as requested (e.g., pharmacological action explanations, detailed解读of market access certificates, price justification like cost sheets or market quotes).
  • During sampling, cooperate with officers on sampling records, clearly noting sampled batch numbers, quantities, and test items. Retain sampling receipts.
• Handling Abnormal Situations:
  • If issues like packaging damage or quantity shortage are found, immediately explain to the officer, providing evidence (e.g., transport records, damage photos) to seek leniency.
  • If officers question the HS code or declaration elements, provide authoritative classification bases (e.g., Customs Tariff Interpretation Notes, Binding Tariff Rulings).
  • If sampling test results are不合格, proactively cooperate with the Customs investigation, analyze the cause. If non-quality related (e.g., contamination during transport), provide evidence to apply for review.

IV. Clearance Release and Follow-up Matters (Process Wrap-up Phase)

(1) Clearance Release Conditions and Process

• Release Conditions:
  • Declaration documents are complete and compliant, with consistent information.
  • All taxes and duties have been fully paid.
  • Customs inspection is passed (or sample testing results are qualified).
  • No other violations of Customs regulations exist.
• Release Process:
  • Once all conditions are met, Customs stamps a “Release” endorsement on the declaration form or sends an electronic release instruction via the “Single Window.”
  • The enterprise presents the release proof (paper release note or electronic instruction) to pick up goods from the Customs supervision area. The appointed logistics provider then handles subsequent transport and loading onto vessel/aircraft.
  • After release, Customs shares relevant data with authorities like the NMPA and tax administration, completing regulatory information exchange.

(2) Follow-up Matters and Document Archiving

• Export Tax Rebate Processing:
  • Drug exports qualify for VAT zero-rating. After clearance, enterprises can apply to tax authorities for an export tax rebate using documents like the customs declaration form, commercial invoice, export sales contract, and VAT special invoices.
  • The rebate application must be filed within 90 days from the export declaration date. Applications beyond this period are ineligible.
  • Tax authorities verify the authenticity and compliance of rebate materials. Anomalies may trigger a rebate assessment or tax audit.
• Document Archiving Management:
  • Per the Drug Administration Law and Customs Law, export drug declaration documents, clearance papers, and quality records must be retained for at least 1 year after the drug’s expiry date and be traceable.
  • Archived documents include: Customs declaration form, commercial invoice, packing list, Drug Export Sales Certificate, CoA, inspection records, tax payment receipts, and export rebate documents.
  • A combined electronic and paper filing system is recommended for secure and accessible record-keeping.
• Adverse Event Follow-up Tracking:
  • Post-export, enterprises must establish a mechanism for reporting adverse reactions occurring overseas, promptly collecting and analyzing drug usage data in target markets.
  • In case of serious adverse reactions or quality issues, immediately report to the NMPA and the importing country’s regulatory agency, and cooperate with investigations and recalls if needed.
  • Related reports and handling records must be incorporated into the export drug file for potential regulatory review.

V. Common Compliance Risks and Mitigation Strategies

(1) Common Compliance Risks

• Flawed Qualification Documents: Expired Drug Export Sales Certificate, target market access certificates failing Customs verification, lack of special export permits for controlled drugs.
• Declaration Errors: Incorrect HS code classification, omission or false declaration of elements, inconsistent document information.
• Inspection Failures: Goods not matching declaration, packaging/labeling non-compliant, failed sample testing.
• Tax Rebate Risks: False rebate materials, failure to apply within the stipulated period, non-compliance with rebate policy requirements.
• Policy Change Risks: Changes in export regulations, tariff policies, or target market requirements that the enterprise fails to address promptly in its declaration strategy.

(2) Mitigation Strategies

• Establish a Compliance Review Mechanism:
  • Set up a dedicated compliance department or role to audit declaration documents, focusing on document validity, accuracy of declaration elements, and consistency.
  • Conduct regular compliance training to enhance the expertise of declaration and customs brokerage staff, keeping them updated on the latest regulations and operational norms.
• Strengthen Policy Change Tracking:
  • Create a global database for pharmaceutical export regulations. Monitor policy updates from the NMPA, GAC, and tax authorities in real-time (e.g., adjustments to certificate management rules, tariff rate changes).
  • Stay informed of regulatory changes in target markets and adjust declaration documents and strategies promptly to avoid compliance risks.
• Optimize Document Management System:
  • Adopt standardized templates for declaration documents, specifying completion requirements and audit workflows to reduce human error.
  • Implement a document expiry预警system. Set reminders for key documents like the Drug Export Sales Certificate and GMP certifications to initiate renewal or updates well in advance.
• Enhance Risk Response Capability:
  • If declaration errors occur, immediately apply to Customs for amendment of the declaration form to avoid加重penalties due to delay.
  • If inspection fails, actively cooperate with the Customs investigation, analyze the root cause, implement corrective actions, and seek legal support from professional lawyers if necessary.
  • Purchase export credit insurance to cover economic losses from clearance delays, cargo seizures, or returns.

Conclusion

The declaration and clearance stages of pharmaceutical exports are a dual test of compliance requirements and practical skills, demanding that enterprises embed a “compliance-first” philosophy throughout the entire process. From pre-export qualification verification and document preparation, to precise declaration filing and follow-up, and to proactive cooperation and risk response during Customs inspections, each step must strictly adhere to regulatory requirements and standardized operational procedures.

In practice, enterprises should strengthen their compliance system建设, enhance the competency of specialized personnel, and maintain vigilance regarding policy dynamics. Simultaneously, partnering with experienced customs brokers and logistics providers specializing in pharmaceutical exports can create synergistic support. Only through these measures can enterprises ensure efficient and smooth declaration and clearance for drug exports, avoid compliance pitfalls, and lay a solid foundation for their products to successfully enter global markets.

As the internationalization of China’s pharmaceutical industry accelerates, the regulatory framework for drug exports will continue to evolve, with oversight likely to become increasingly stringent. Enterprises must maintain a respectful attitude towards regulations, continuously optimize their compliance management strategies, and achieve the sustainable and healthy development of their drug export business within the boundaries of global regulatory rules.