A Comprehensive Guide to Exporting Pharmaceuticals from China: Compliance Requirements and Global Market Access

A Comprehensive Guide to Exporting Pharmaceuticals from China: Compliance Requirements and Global Market Access

With the restructuring of the global pharmaceutical supply chain and the high-quality development of China’s pharmaceutical industry, drug exports have become a core pathway for Chinese pharmaceutical companies to expand market share and enhance international competitiveness. The new “Regulations for the Inspection of Drug Exporting Manufacturers and the Management of Export Certificates” issued by the National Medical Products Administration (NMPA) in 2025 further optimizes export facilitation measures, providing policy support for Chinese pharmaceuticals to “go global.” However, compliance barriers and regulatory differences in international markets still pose significant challenges for exporting enterprises. This article provides a comprehensive analysis of domestic compliance requirements, global market access rules, practical procedures, and risk response strategies for pharmaceutical exports, offering systematic guidance for companies expanding internationally.

I. Domestic Compliance Foundation: Policy Framework and Core Requirements

The compliance system for pharmaceutical exports from China is fundamentally based on the “Drug Administration Law” and the “Regulations for the Supervision and Administration of Drug Production.” The “Regulations for the Inspection of Drug Exporting Manufacturers and the Management of Export Certificates” (hereinafter referred to as the “Regulations”), implemented in 2025, further details operational requirements, forming a three-dimensional regulatory system of “production compliance + certificate management + supervision and inspection.”

(1) Definition of Export Drugs and Qualification Requirements

According to the “Regulations,” export drugs specifically refer to marketed or to-be-marketed products produced by enterprises holding a “Drug Manufacturing License” within China, exported to other countries (regions), and managed as drugs. This includes finished dosage forms, active pharmaceutical ingredients (APIs), traditional Chinese medicine formula granules, etc. Intermediate products for formulations can apply for export certificates by reference. Core qualification requirements include: production activities must be carried out in workshops and production lines specified on the “Drug Manufacturing License,” strictly following Good Manufacturing Practice (GMP) standards. If an enterprise also produces non-pharmaceutical products, even those with pharmacological activity, they cannot be exported under the name of drugs, nor can documents issued by the drug regulatory authority be used.

For production scopes dedicated to exports, enterprises should apply for GMP compliance inspections for export drugs simultaneously when applying for the issuance, change, or renewal of their “Drug Manufacturing License.” If an enterprise has not had any license changes after the “Regulations” take effect, it can submit the application during license renewal to ensure that key information such as the production address and scope for export drugs is specified on the license, which is a prerequisite for applying for export certificates.

(2) Key Updates in Export Certificate Management

The optimized adjustments in the “Regulations” directly reduce the compliance costs and time costs for enterprises:

• Broadened Scope for Certificate Issuance: Regardless of whether the drug is marketed domestically, as long as it meets GMP requirements, it can apply for an export certificate, covering previously restricted categories such as unmarketed new drugs and APIs.
• Extended Validity Period: The validity period of the “Drug Export Sales Certificate” has been extended from 2 years to 3 years, aligning with the “Certificate of a Pharmaceutical Product for the Export of APIs to the EU.” Enterprises can also apply for certificate updates when required by the importing country to avoid “gaps.”
• Clarified Processing Time Limits: The maximum processing time for provincial-level Medical Products Administrations is clearly defined as not exceeding 20 working days, excluding time for technical review, on-site inspections, and rectification, improving approval efficiency.
• Internationalized Template: The latest format recommended by the WHO in 2021 is adopted, better aligning with international trade certification programs for pharmaceuticals and reducing cross-border recognition barriers.

(3) Production Compliance and Supervision Inspection Requirements

To comply with WHO National Regulatory Authority (NRA) assessments and Pharmaceutical Inspection Co-operation Scheme (PIC/S) access standards, the “Regulations” strengthen the full-process compliance control of export drugs:

• Establish an Export Drug File: Enterprises must report information such as production and sales, quality standards, labeling, and package inserts into the regulatory information system, covering the differentiated requirements of various importing countries. Data for the previous year’s production and sales must be updated by April 30th each year.
• Targeted Inspection Mechanism: Provincial-level Medical Products Administrations implement precise inspections based on export certificate information, focusing on GMP compliance verification.
• Extension of Inspection Coverage: Storage and transportation enterprises are subject to audits and extension inspections by regulatory authorities. Enterprises must clarify responsible entities through commitments, transportation agreements, etc., to ensure end-to-end quality control of drugs.

II. Analysis of Global Major Market Access Rules

Different countries and regions have significant differences in their pharmaceutical regulatory systems, but regulatory convergence is becoming a trend, with ICH guidelines serving as a common foundation for many regulators. The following analyzes core access requirements for key markets targeted by Chinese pharmaceutical companies:

(1) US Market: The Stringent FDA Regulatory System
The US is one of the most strictly regulated pharmaceutical markets globally. The core access path revolves around FDA registration:

• Establishment Registration Requirement: All facilities that manufacture, repackage, or relabel drugs intended for the US market must register with the FDA, obtain a Facility Establishment Identifier (FEI), and submit registration data in Structured Product Labeling (SPL) format via the electronic Drug Registration and Listing System (eDRLS).
• Product Registration Categories: Products are managed by classification based on risk level. New drugs require a New Drug Application (NDA), generic drugs require an Abbreviated New Drug Application (ANDA), and biological products require a Biologics License Application (BLA).
• Ongoing Compliance Requirements: Enterprises must update their registration information annually between October 1st and December 31st. Product changes must be reported promptly. An adverse event reporting system must be established, complying with FDA’s Current Good Manufacturing Practice (cGMP) requirements.

(2) EU Market: Regulatory Reforms and New HTA Requirements
EU pharmaceutical regulation is undergoing significant changes, with new regulations effective in 2025 further optimizing access rules:

• Adjustment of Regulatory Data Protection Period: The exclusivity period for new drugs is no longer fixed at 8 years but can be adjusted based on public health contribution, with a possible extension up to 12 years, balancing innovation incentives and market competition.
• Implementation of New HTA Regulations: Advanced therapy medicinal products and innovative oncology products require submission of PICO (Population, Intervention, Comparator, Outcome) materials for Health Technology Assessment, impacting pricing and reimbursement approvals.
• Registration Pathways: Marketing authorization can be applied for via the Centralized Procedure (applicable across the EU), Decentralized Procedure (applicable in multiple Member States), or National Procedure (applicable in a single Member State). APIs require a “Certificate of a Pharmaceutical Product for the Export of APIs to the EU.” Manufacturing sites must comply with GMP requirements and undergo inspection.

(3) Asia-Pacific Market: Differentiated Regulation and Access Facilitation
The Asia-Pacific market exhibits diverse regulatory characteristics, with some countries recently introducing new rules to optimize access processes:

• Australia: Therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG). They are classified by risk level into Listed (low-risk OTC) and Registered (prescription, high-risk OTC) categories. International scientific guidelines are adopted, and some international certification results are recognized.
• Vietnam: The “Guidelines for Registration of Drugs and Drug Ingredients” implemented in April 2025 clarifies registration document requirements for modern drugs, vaccines, biologicals, etc., covering the issuance, renewal, and revocation of marketing authorizations. Enterprises must submit technical dossiers complying with local language requirements.
• Japan & South Korea: Japan’s PMDA requires submission of complete clinical data and quality system documents for drugs, and ISO 13485 certification is often needed. South Korea’s MFDS classifies drugs into four categories; high-risk categories typically require a KGMP certificate and local clinical trial data.

(4) International Organization Procurement Channel
For drugs that have not obtained marketing authorization in the importing country but are procured by international organizations, enterprises can export compliantly through special pathways:

• If a product has obtained WHO Prequalification (PQ) or is authorized for production by the Medicines Patent Pool (MPP), the provincial-level Medical Products Administration can specify the relevant production information in the “Drug Manufacturing License” and may waive on-site inspection when processing the “Drug Export Sales Certificate.”
• The export file should provide documents meeting international organization procurement requirements, substituting for materials related to the importing country’s marketing authorization.

III. Practical Procedures and Compliance Management for Drug Exports

(1) Full-Process Operational Guide

• Preparation Phase:
  • Qualification Verification: Confirm that the “Drug Manufacturing License” covers the export categories and production scope. Complete the GMP compliance inspection for export drugs.
  • Market Research: Analyze the registration requirements, quality standards, labeling specifications, and trade barriers of the target market.
  • File Establishment: Report the export drug file into the regulatory information system, clarifying differentiated product information for each importing country.
• Export Certificate Application Phase:
  • Document Submission: Includes application forms, GMP compliance certificates, manufacturing process descriptions, quality standards, etc., using the latest WHO-recommended template.
  • Timeline Management: The maximum processing time for provincial-level authorities is 20 working days. Time for technical review and rectification must be factored in to avoid impacting shipments.
• Target Market Registration Phase:
  • Dossier Preparation: Compile Common Technical Document (CTD) format submission materials according to target market requirements, including pharmaceutical, pharmacological/toxicological, and clinical study data.
  • Communication and Liaison: Communicate with the regulatory agency through a local authorized representative, respond to requests for supplementary information, and cooperate with on-site inspections or sample testing.
• Customs Clearance and Post-Market Phase:
  • Customs Declaration Documents: Include the “Drug Export Sales Certificate,” importing country registration documents, packing list, commercial invoice, etc., ensuring consistency across all documents.
  • Storage and Transportation: Select logistics providers compliant with GMP requirements, sign transportation agreements, and specify temperature control and traceability requirements.
  • Adverse Event Monitoring: Establish a mechanism for reporting adverse reactions occurring overseas and promptly report to both domestic and foreign regulatory authorities as required.

(2) Core Points of Compliance Management

• Continuous Quality System Compliance: The production of export drugs must fully adhere to GMP standards. Risks of cross-contamination from sharing production lines with non-pharmaceutical products must be avoided. Regular internal audits should be conducted.
• Standardized Document Management: Complete records of export certificates, registration dossiers, production records, etc., must be retained to ensure traceability. Changes to file information must be updated promptly.
• Tracking Regulatory Developments: Establish a global regulatory intelligence database. Stay updated on ICH guideline revisions and policy adjustments in target markets (e.g., EU HTA reforms, US FDA electronic submission requirements) to adjust compliance strategies timely.
• Management of Contract Manufacturing: If contract manufacturing is involved, the marketing authorization holder (contract giver) bears primary responsibility. They must ensure the contract acceptor complies with GMP requirements and is subject to extension inspections.

IV. Risk Response and Development Recommendations

(1) Major Risks and Mitigation Strategies

• Regulatory Change Risk: Global regulatory policies are continuously updated (e.g., EU pharmaceutical law reforms, Vietnam’s guideline adjustments). Enterprises should establish a regulatory alert mechanism and collaborate with professional CRDMOs or local authorized representatives to respond quickly to policy changes.
• Registration and Approval Risk: Some markets have long approval cycles and stringent requirements. Prioritizing markets with higher regulatory convergence (e.g., countries recognizing ICH guidelines) and utilizing international multi-center clinical trial data can reduce registration costs.
• Quality Compliance Risk: If quality issues arise with export drugs, enterprises may face notifications, recalls, or even market bans. It is crucial to strengthen end-to-end quality control and cooperate with inspections and investigations by domestic and foreign regulatory authorities.
• Trade Barrier Risk: Some countries set up technical or intellectual property barriers. Conducting patent landscaping in advance and ensuring manufacturing processes and product labeling do not infringe on others’ intellectual property rights is essential.

(2) Recommendations for Industry Development

• Maximize Policy Benefits: Fully utilize the facilitation measures introduced by the “Regulations,” such as the 3-year validity period for export certificates and special channels waiving on-site inspections, to reduce compliance costs.
• Drive Innovation Through Technology: Focus on competitive advantage categories like APIs, specialized formulations, and biologics. Enhance product competitiveness through international multi-center clinical trials, addressing unmet global medical needs.
• Adopt Collaborative and Win-Win Models: Partner with CRDMOs possessing international registration experience. Leverage their regulatory databases, official communication channels, and submission expertise to increase registration success rates.
• Deepen Regional Market Presence: For emerging markets like those along the “Belt and Road,” utilize policy incentives and regulatory cooperation mechanisms to gradually establish local service networks and enhance market penetration.

Conclusion

The export of pharmaceuticals from China is experiencing a dual opportunity of policy support and growing global demand. However, compliance is the prerequisite for successful international expansion. Enterprises must firmly grasp the domestic compliance foundation, accurately adapt to the regulatory requirements of target markets, and navigate global market access channels through standardized process management, continuous quality improvement, and flexible risk response. As the innovation capabilities of China’s pharmaceutical industry strengthen and its regulatory system becomes more internationalized, more high-quality Chinese pharmaceuticals will enter the global market. This will provide more accessible medical options for patients worldwide while propelling the Chinese pharmaceutical industry towards the high end of the value chain.