China Launches Pilot to Streamline Imports of Food-Medicine Substances

On December 3, 2025, four Chinese authorities — the General Administration of Customs (GACC), National Health Commission (NHC), State Administration for Market Regulation (SAMR), and National Medical Products Administration (NMPA) — jointly issued the “Announcement on the Pilot Implementation of Classified Management Measures for Imported Food-Medicine Substances” (“Announcement [2025] No. 237”).

Effective immediately, the announcement introduces a pilot framework for classifying imported food-medicine substances based on declared use. The pilot targets long-standing customs inefficiencies caused by the substances’ “dual identity” as both food ingredients and medicinal materials. For overseas manufacturers, traders, and brand owners, the pilot reshapes import procedures, compliance responsibilities, and market entry timelines for China.

Regulatory Context Behind Food-Medicine Substance Management

Understanding the pilot requires context on how China has historically regulated food-medicine substances. These materials are rooted in the traditional concept of “medicine and food sharing the same origin,” which has long influenced Chinese food and health product regulation.

The modern legal foundation was established in the 2015 revision of the “Food Safety Law of the People’s Republic of China.” The law clearly states that pharmaceuticals may not be added to food, while substances traditionally recognized as both food and Chinese medicinal materials may be used in food products.

Further clarification followed in the 2019 revision of the “Implementation Regulations of the Food Safety Law,” which required health authorities and food safety regulators to update the food-medicine substance catalogue on a timely basis. However, despite this mandate, the catalogue has evolved slowly. After the first list of 33 substances issued in 1987, it expanded to 87 items in 2002 and has since seen only limited pilot-based adjustments.

Under the previous regulatory model, imported food-medicine substances faced persistent identity recognition issues at customs. When a substance appeared both in the food-medicine catalogue and the “Imported Drug Catalogue,” customs authorities typically required submission of an Imported Drug Customs Clearance Form, regardless of the importer’s intended use. This approach created significant obstacles for food processors and traders without pharmaceutical qualifications, often forcing reliance on licensed drug companies as import agents, increasing costs and extending clearance timelines.

Core Changes Introduced by the Four-Ministry Pilot

The pilot program introduces a more differentiated regulatory approach designed to align customs supervision with actual product use. Several structural changes define the new system.

• List-based management: The “Pilot List of Food-Medicine Substances under Classified Import Regulation” becomes the primary reference for determining which substances fall within the pilot scope. Authorities have indicated that this list will be updated dynamically to reflect regulatory experience and market demand.
• Use-based clearance principle: Imports declared for medicinal use must continue to submit an Imported Drug Customs Clearance Form. In contrast, substances declared for non-medicinal purposes, such as food processing or seasoning, are exempt from this requirement, simplifying customs procedures for non-medicinal imports. Declared uses cannot be changed after importation, and medicinal-use imports may only be used as ingredients in health food production.
• Multi-agency coordination: GACC, SAMR, and NMPA will conduct full-chain supervision within their respective mandates, supported by shared standards and information systems with violations subject to legal accountability. This coordinated approach aims to enhance risk control.

These requirements form the baseline for lawful participation in the pilot and should guide immediate operational changes.

Opportunities for Overseas Enterprises

With regulatory boundaries clarified, the pilot creates tangible opportunities for overseas enterprises. The most immediate benefit for overseas producers and traders is reduced entry barriers. Food processors and health product traders previously excluded due to a lack of pharmaceutical qualifications can now import eligible substances by declaring non-medicinal use, without submitting an Imported Drug Customs Clearance Form. This change reduces reliance on third-party pharmaceutical agents and shortens import timelines.

Beyond procedural simplification, the pilot also aligns with China’s broader health policy direction. Under the Healthy China Strategy, together with initiatives such as the “National Nutrition Plan (2017–2030)” and the “14th Five-Year Plan for Traditional Chinese Medicine Development,” regulators have emphasized expanding the food-medicine catalogue and supporting the development of health-oriented products.

Against this policy backdrop, demand for high-quality imported food-medicine substances is expected to remain strong. Overseas suppliers that meet Chinese regulatory requirements are therefore well-positioned to benefit from the more flexible import framework. In particular, premium products used in spices, seasonings, and health food ingredients may gain market share through quality differentiation and clearer regulatory pathways.

Key Compliance Requirements Under the Pilot Framework

In light of these changes, overseas enterprises should take structured and proactive steps to align operations with the new classified management regime. Companies must establish robust use-control systems to ensure declared and actual uses remain consistent throughout the supply chain.

Conduct a Product Classification Review

Compare each imported product against the pilot list and the NHC catalogue of substances recognized as both food and medicinal materials. Next, determine the correct declaration (medicinal or non‑medicinal), and closely monitor list updates. For products not yet included in the pilot list but with strong market demand, consultation with regulatory specialists is advisable before import.

Perform a Compliance Risk Assessment

Review existing import processes and documentation to ensure alignment with the pilot requirements. Confirm that importer qualifications, product testing reports, and applicable Chinese standards are in place. For non-medicinal declarations, verify that stated uses, such as food processing or seasoning, are accurate and defensible.

Implement Full-Chain Traceability Controls

Establish traceability mechanisms covering procurement, customs clearance, and downstream sales. Clear records demonstrating product flow and intended use reduce enforcement risk and support timely responses to regulatory inquiries from customs or market supervision authorities.

Final Thoughts

The pilot programme for classified management of imported food-medicine substances marks a meaningful step in China’s efforts to optimize its business environment and modernize health-related regulation. By easing clearance requirements for non-medicinal imports, it creates new commercial opportunities for overseas suppliers. At the same time, it raises compliance expectations around truthful declaration, use control, and traceability.

Early, disciplined action will allow overseas enterprises to capture market opportunities while avoiding enforcement risks. Given the complexity and the need for precise implementation, partnering with experienced regulatory advisers is strongly recommended.

For tailored regulatory support interpreting the pilot, optimising compliance processes, and accelerating market entry in China, contact Cisema today.

Further Information

Explore Cisema’s health food regulatory services in China.

References

Read the official announcement jointly issued by the General Administration of Customs, National Health Commission, State Administration for Market Regulation, and State Food and Drug Administration here.