Can Foreign Manufacturers Import APIs Directly into China?

For foreign active pharmaceutical ingredient (API) manufacturers, the question of whether they can import APIs directly into China has become increasingly relevant as China solidifies its position as the world’s second-largest pharmaceutical market. The short answer is yes — foreign manufacturers can import APIs directly into China — but the regulatory pathway is complex, involving coordinated compliance with the NMPA’s drug master file requirements, customs regulations, GMP standards, and a newly evolving framework for API registration and oversight. Understanding this landscape is essential for any foreign API manufacturer seeking to participate in China’s growing pharmaceutical supply chain.

The Regulatory Evolution of API Import in China

China’s approach to API regulation underwent a fundamental transformation with the implementation of the 2019 Drug Administration Law and the 2020 Drug Registration Regulation. Under the previous system, APIs were approved separately from finished drug products through a standalone registration process with its own certificate number. The new framework shifted to a master-file system more closely aligned with international practice, where API registration is linked to the finished drug product registration while maintaining an independent review process.

The key regulatory bodies involved in API import include:

• National Medical Products Administration (NMPA): Responsible for API registration and quality oversight
• Center for Drug Evaluation (CDE): Reviews API master files and conducts technical evaluations
• General Administration of Customs (GAC): Enforces import controls and inspects shipments at ports of entry
• Chinese Pharmacopoeia Commission: Sets quality standards for APIs through the Chinese Pharmacopoeia (ChP)
• Institute for Food and Drug Control (NIFDC): Conducts testing and verification of imported APIs when required

API Registration Pathway: The Master File System

Drug Master File (DMF) Submission

Since the implementation of the 2020 Drug Registration Regulation, foreign API manufacturers must submit a Drug Master File (DMF) to the CDE. The DMF, known locally as the “Yuanliao Yao Dang’an” (YYA), contains detailed information about the API’s manufacturing process, quality control, stability, and packaging. The submission is made through the CDE’s online portal and must be accompanied by the following:

• API manufacturer information (legal entity, manufacturing site details, contact information)
• Product description (chemical structure, physicochemical properties, specifications)
• Manufacturing process description (synthetic route, process flow diagram, critical process parameters)
• Process validation data
• Characterization of impurities and degradation products
• Specifications and analytical methods
• Stability data under Chinese Pharmacopoeia conditions
• Packaging and container closure information
• GMP compliance documentation

All DMF materials must be submitted in Chinese, with key documents (certificates, analytical methods, stability reports) requiring certified translation. The CDE is increasingly moving toward electronic-only submissions with digital signatures, and foreign manufacturers should ensure they have the technical capability to submit through the CDE’s platform.

DMF Review and Activation

Upon submission, the CDE assigns a unique DMF number and begins the technical review process. The review timeline depends on the API’s complexity and risk classification:

• Standard review: 120 to 200 working days for most API types
• Priority review: 60 to 100 working days for APIs used in drugs with breakthrough therapy designation or orphan drug status
• Complex APIs: Extended review up to 280 working days for biotechnology-derived APIs, high-potency APIs, and controlled substances

The DMF is activated only when it is referenced by a finished drug product application. A single DMF can be referenced by multiple drug product applicants, all of whom require the API manufacturer’s written authorization to reference the DMF. Foreign manufacturers should carefully manage DMF reference authorizations to control their business relationships with Chinese drug product manufacturers.

GMP Requirements for Foreign API Manufacturers

Foreign API manufacturers seeking to import into China must demonstrate compliance with NMPA GMP standards. The NMPA requires that all foreign API manufacturing sites undergo GMP inspection, either through on-site inspection by the CFDI or through acceptance of GMP certificates from recognized foreign regulatory authorities.

As of 2026, the following approaches are available:

Full On-Site Inspection

The CFDI conducts a comprehensive GMP inspection of the foreign API manufacturing facility. This approach is required for APIs manufactured in countries without mutual recognition agreements with China, and for APIs classified as high-risk (sterile APIs, biotechnology-derived APIs, and APIs with narrow therapeutic windows).

Document-Based GMP Review

For foreign manufacturers in countries that have GMP mutual recognition agreements with China, or for API manufacturers with recent successful inspections by FDA or EMA, the NMPA may accept a document-based GMP review without an on-site inspection. The manufacturer must submit GMP certificates, recent inspection reports, and a declaration of GMP compliance.

Remote GMP Assessment

In selected cases, the NMPA may conduct a remote GMP assessment using video technology and document sharing. This approach has become more common since the COVID-19 pandemic but remains limited to lower-risk APIs and manufacturers with established compliance records.

Import Documentation and Customs Clearance

Beyond NMPA registration, foreign API manufacturers must navigate China’s customs clearance process, which requires the following documents:

• Drug Import Registration Certificate: The DMF activation confirmation serves as the primary regulatory clearance document for API import.
• Certificate of Pharmaceutical Product (CPP): Issued by the competent authority of the exporting country, this certificate confirms the API is approved for marketing in the country of origin.
• Certificate of Analysis (CoA): Batch-specific CoA from the manufacturer.
• Bill of Lading and Commercial Invoice: Standard shipping and customs documentation.
• Certificate of Origin: May affect import duty rates under China’s free trade agreements.
• GMP Certificate: Current GMP certificate from the manufacturer’s home regulatory authority.
• Sanitary Certificate: May be required for certain API categories.

Imported APIs are subject to inspection at the port of entry by the local branch of the NIFDC. The inspection includes identity testing, assay, impurity analysis, and microbiological testing (for relevant API types). Some low-risk APIs may qualify for a reduced inspection protocol under the NMPA’s risk-based inspection system.

Tariffs and Duties on Imported APIs

The tariff structure for imported APIs in China has become more favorable in recent years. As of 2026, most APIs classified as pharmaceutical raw materials enjoy reduced tariff rates under Category 29 of the Harmonized System. Current import duties typically range from 0% to 6% for most API categories, with the following considerations:

• WTO Information Technology Agreement APIs: Certain pharmaceutical intermediates are duty-free.
• Free Trade Agreement (FTA) preferential rates: APIs imported from FTA partner countries (including ASEAN, Australia, New Zealand, South Korea, and others) may qualify for reduced or zero duty rates with a valid Certificate of Origin.
• Most Favored Nation (MFN) rates: Standard tariff rates applied to WTO members, generally 4-6% for most API categories.
• VAT: A 13% value-added tax applies to all API imports, calculated on the CIF value plus import duty.

Strategic Considerations for Foreign API Manufacturers

Direct vs. Distributor-Led Import

Foreign API manufacturers have two main options for accessing the Chinese market: directly registering as a foreign API supplier and selling to Chinese drug manufacturers, or working through a Chinese distributor who handles registration, import clearance, and local distribution. While direct registration provides greater control and potentially higher margins, the investment in regulatory compliance, local representation, and relationship management is substantial. Many foreign manufacturers initially enter the market through distributors while pursuing direct registration in parallel.

Choosing a China-Based Agent

For foreign manufacturers without a legal entity in China, the NMPA requires designation of a China-based agent responsible for communication with the regulatory authorities. The agent must be a legal entity registered in China and must accept regulatory and legal liability for the API’s compliance. Choosing a qualified agent — whether a regulatory consulting firm, a pharmaceutical trading company, or a law firm — is a critical decision that affects the entire registration and import process.

Quality Standards and the Chinese Pharmacopoeia

One of the most common challenges for foreign API manufacturers is ensuring their products meet the specific requirements of the Chinese Pharmacopoeia (ChP). While many analytical methods are harmonized with USP and EP, differences exist in impurity limits, specific tests, and acceptance criteria. Foreign manufacturers should conduct a comprehensive gap analysis between their existing quality specifications and ChP requirements before initiating the registration process.

Market Trends and Future Outlook

The API import landscape in China continues to evolve. China’s dual-circulation economic strategy emphasizes both domestic production and international trade in pharmaceutical raw materials. Recent policy developments point to greater openness to high-quality foreign APIs, particularly for complex and innovative molecules that cannot be easily produced domestically. The CDE has streamlined API registration processes, reduced review timelines, and expanded mutual recognition of foreign GMP inspections. As China continues to align its pharmaceutical regulatory framework with international standards through PIC/S membership efforts, foreign API manufacturers can expect further improvements in market access conditions.

Conclusion

Foreign manufacturers can indeed import APIs directly into China, but the pathway requires comprehensive regulatory compliance spanning NMPA drug master file registration, GMP certification, customs clearance, and quality standard alignment. The complexity of the registration and import process makes early engagement with Chinese regulatory authorities and careful selection of local partners essential for success. As China’s pharmaceutical market continues to grow and its regulatory framework continues to harmonize with international standards, foreign API manufacturers that invest in understanding and navigating these requirements will be well-positioned to participate in one of the world’s most dynamic pharmaceutical supply chains.

Disclaimer: This article provides general information and does not constitute legal or regulatory advice. Foreign API manufacturers should consult with qualified regulatory affairs professionals and customs brokers for their specific import strategies.