Published by ChinaMNC · Yinchuan
China's 2025 Drug Catalog Updates: Key Compliance Points for Foreign Pharma and Health Companies
China's National Healthcare Security Administration (NHSA) and Ministry of Human Resources and Social Security issued the 2025 drug catalog for basic medical insurance, maternity insurance, work injury insurance, and the new commercial health insurance innovative drug catalog. For foreign founders in pharma, biotech, or health services, this affects product listing, pricing, and market access. Here's what you need to know to stay compliant and leverage opportunities.
What the 2025 Drug Catalog Means for Your China Operations
If you run a foreign-invested pharmaceutical, biotech, or health insurance company in China, the latest drug catalog updates directly impact your product reimbursement, pricing strategies, and market access. The National Healthcare Security Administration (NHSA) and the Ministry of Human Resources and Social Security have released the 2025 catalog for basic medical insurance, maternity insurance, and work injury insurance, alongside a new commercial health insurance innovative drug catalog. The new catalog takes effect on January 1, 2026, replacing the 2024 version. For foreign founders, understanding these changes is crucial for compliance and commercial success.
Key Takeaways for Foreign-Founded Companies
- New catalog effective January 1, 2026: All medical institutions and pharmacies must update their systems and databases to reflect the new list. If your products are included, ensure they are properly registered in provincial procurement platforms by the end of December 2025.
- Transition period for delisted drugs: Drugs that failed to renew their negotiated status have a 6-month transition (until end of June 2026) where insurance funds continue to pay at original standards. This gives companies time to adjust.
- National uniform payment standards: Negotiated and competitive-bid drugs have nationwide payment standards set by the NHSA. For competitive-bid drugs, the payment standard is the benchmark for insurance reimbursement for the same generic name. Actual market prices above the standard mean patients pay the difference; below the standard, reimbursement is based on actual price.
- Confidentiality of certain payment standards: Payment standards marked with an asterisk (*) in the catalog must not be publicly disclosed by local authorities.
- Commercial health insurance innovative drug catalog: This new list is not covered by basic medical insurance funds. However, it opens opportunities for commercial insurers to design products covering these innovative drugs, and for medical institutions to use them without affecting certain metrics.
Implications for Product Listing and Pricing
For foreign companies with drugs in the catalog, you must ensure your products are listed on provincial drug procurement platforms by the end of December 2025. Negotiated drugs cannot be listed at prices higher than the payment standard. If a generic version of a negotiated drug enters the market during the agreement period, the listing price must also not exceed the payment standard. Companies that participated in on-site bidding must keep their listing prices at or below their bid price during the payment standard validity period.
For drugs not in the catalog but with the same generic name as negotiated drugs, provincial authorities may adjust payment standards based on market competition. If your drug is included in national centralized procurement or government pricing, provincial authorities may adjust the payment standard accordingly.
Compliance in Medical Institutions
Medical institutions and work injury rehabilitation institutions are required to hold pharmacy meetings by the end of February 2026 to adjust drug formularies or set up temporary procurement channels. Negotiated drugs are exempt from the "one product, two specifications" restriction and cannot be hindered by insurance总额 controls, formulary limits, or drug proportion targets. Foreign companies should work with their distribution partners to ensure timely access.
For innovative drugs in the catalog, if standard disease-based payment (DRG/DIP) is not suitable, hospitals can apply for special case review. Local insurance departments must simplify procedures and organize expert reviews quarterly or monthly, then pay per project or adjust payment standards.
Dual-Channel Management and Retail Pharmacy
Provincial insurance departments must update their dual-channel (hospital and pharmacy) and separate payment lists for negotiated drugs, synchronized with the new catalog. Drugs cannot be removed from dual-channel status solely because they transition to regular catalog management. Retail pharmacies dispensing dual-channel drugs must use the electronic prescription center. Foreign companies should ensure their authorized pharmacies are compliant.
Commercial Health Insurance Innovative Drug Catalog: Opportunities
The new commercial health insurance innovative drug catalog is not paid by basic medical insurance funds and does not count toward basic insurance self-payment rate indicators or centralized procurement monitoring. Commercial insurers are encouraged to design new products, update coverage, and adjust payment methods based on this catalog. Local insurance departments may explore allowing retail pharmacies to stock these drugs and monitor prices. Real-world data evaluations are encouraged. Foreign insurers and pharma companies can collaborate to offer innovative coverage.
Monitoring and Reporting
Provincial insurance and human resources departments must monitor drug availability and usage, report to the NHSA, and oversee fund payments, especially for separately paid drugs. Companies should ensure supply security and respond to procurement and clinical needs. Non-compliance can lead to penalties.
What This Means for Your China Company Registration
If you are setting up a foreign-invested enterprise (FIE) in China's healthcare sector, be aware that drug catalog inclusion is a key market access milestone. Your business license and scope must cover pharmaceutical production, distribution, or health services as applicable. For distribution, you need a Drug Distribution License; for manufacturing, a Drug Production License. Compliance with catalog listing and pricing rules is ongoing. Ensure your local partner or subsidiary handles provincial procurement platform registrations and reporting.
For commercial insurance, you may need a license from the National Financial Regulatory Administration. The new commercial health insurance catalog offers a pathway to offer innovative drug coverage, but coordinate with local insurance bureaus.
Foreign founders should also note that the catalog updates are part of broader healthcare reforms. Staying informed helps in strategic planning, but specific product inclusion depends on negotiations with the NHSA.
Call to action: Foreign founders can contact ChinaMNC on WhatsApp / WeChat at +86 153 1898 8535 for help registering and operating a company in China.
This summary is based on information published by the relevant Chinese government website and is general information, not legal or tax advice.