Since November 2025, a series of new regulations on pharmaceutical oversight have been progressively implemented. Let’s take a look at which ones directly affect you.

Pharmaceutical Traceability System: By 2026, “no scan without a code” will be fully implemented and upgraded to an early-warning interception mechanism.

Effective January 1, 2026, all pharmaceutical production, distribution, and use entities nationwide will fully implement mandatory scanning of drug traceability codes. To further strengthen risk management, the National Medical Products Administration issued new regulations in March 2026, requiring drug traceability platforms to issue alerts for products that fail to comply with scanning requirements or exhibit data anomalies. Until such alerts are resolved, the affected drugs may not be accepted into inventory, sold, or used. In addition, a dedicated reporting and review mechanism has been established for “code‑less” drugs to ensure traceability in special circumstances.

Related Reading: https://www.nmpa.gov.cn (National Medical Products Administration Official Website)

Local Updates: Beijing, Tianjin, Shandong, and other regions are steadily advancing the full‑range barcode‑based traceability system for pharmaceuticals, with a strict regulatory phase—“no sales without a code”—set to take effect in 2026.

Starting November 1, 2025, Beijing, Tianjin, Shandong, and other regions have mandated that un-coded pharmaceutical products may not be admitted into the pharmaceutical distribution chain. Beginning in 2026, these provinces and municipalities will further strengthen oversight, with a particular focus on reviewing the declaration and approval records of “un-coded” drugs and verifying the status of historical inventory clearance. Any business entity found to have illegally sold un-coded pharmaceuticals will face administrative penalties, including warnings, fines, or even revocation of its license, in accordance with the law.

Related Reading:

Beijing: https://yjj.beijing.gov.cn

Tianjin: https://scjg.tj.gov.cn

Shandong: http://mpa.shandong.gov.cn

Electronic prescription circulation: To be fully implemented across multiple provinces and municipalities nationwide starting January 2026, with support for long-term prescriptions.

In January 2026, the Ministry of Commerce and eight other departments jointly issued the “Notice on Improving the Mechanism for Circulating Out-of-Region Prescription Orders under Basic Medical Insurance,” mandating that by the end of June 2026, all localities fully implement the circulation of outpatient pooled‑funds medications through the national electronic prescription center. Provinces such as Hubei, Beijing, and Shandong had already taken the lead in discontinuing the acceptance of paper prescriptions as of November 2025. Starting in 2026, primary-level medical and health institutions will be authorized to issue long‑term prescriptions valid for up to 12 weeks and will support online follow-up visits and prescription refills.

Related Reading: http://www.mofcom.gov.cn (Ministry of Commerce Official Website)

National Medical Products Administration: The “Regulations on the Inspection of Exported Drugs and the Administration of Export Certificates for Pharmaceutical Manufacturers” shall come into force on January 1, 2026.

To further standardize the management of pharmaceutical exports, the National Medical Products Administration’s “Regulations on Inspection and Certification Management for Pharmaceutical Exports” were issued at the end of 2025 and will take effect on January 1, 2026. The regulations consolidate the previous procedures for obtaining export certificates and strengthen requirements for production‑quality inspections and traceability of exported pharmaceuticals.

Related Reading: https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/202512/t20251231_123456.html

Hubei: Starting November 1, medication prescriptions must be processed through the Medical Insurance Electronic Prescription Center; paper prescriptions will no longer be accepted.

The Hubei Provincial Medical Security Bureau’s “Notice on Further Standardizing the Management of Out-of-Pocket Prescription Dispensing for Medical Insurance” stipulates that, effective November 1, 2025, medications reimbursed through the outpatient pooled fund must be prescribed via the medical insurance electronic prescription center; paper prescriptions will no longer be accepted.

Related Reading: https://ybj.hubei.gov.cn/zfxxgk/zc/qtzdgkwj/202412/t20241203_5435734.shtml

Hainan: The “Hainan Province Pharmaceutical Procurement Platform Rules for Online Drug Listing and Transaction Procurement” will take effect on November 1.

The “Rules for Drug Listing and Transaction Procurement on the Hainan Province Pharmaceutical Procurement Platform” (hereinafter referred to as the “Rules”), issued by the Hainan Provincial Medical Insurance Bureau, have been in effect since November 1. The Rules stipulate that enterprises shall implement both self‑determined pricing and agreed‑upon prices. For newly listed drugs, a pilot system of self‑assessment based on pharmaceutical and clinical value will be introduced, requiring pharmaceutical companies to conduct realistic self‑evaluations and set prices accordingly; such self‑determined prices will then be posted on the platform. As for drugs whose prices are determined through negotiations or competitive bidding under the national medical insurance catalog, as well as those selected through national centralized procurement, provincial centralized procurement, or renewal rounds, these drugs will be directly listed at their respective agreed‑upon prices during the term of the contract.

Related Reading: https://ybj.hainan.gov.cn/xxgk/xxgkml/202509/t20250923_3935646.html

Ningxia: The “Regulations of the Ningxia Hui Autonomous Region on the Supervision and Administration of Long-Term Suspension and Resumption of Operations by Pharmaceutical Enterprises” came into effect on November 1.

To standardize the practices of pharmaceutical wholesale enterprises, retail chain headquarters, and retail pharmacies in the Ningxia Hui Autonomous Region regarding long-term suspension of operations and resumption of business, strengthen routine supervision, maintain order in pharmaceutical distribution, and ensure the quality and safety of medicines, the Ningxia Hui Autonomous Region Drug Administration has formulated and promulgated the “Regulations on the Supervision and Administration of Long-Term Suspension and Resumption of Operations by Pharmaceutical Enterprises in the Ningxia Hui Autonomous Region” (hereinafter referred to as the “Regulations”), which will take effect on November 1.

The Regulations focus on issues of concern to the public—namely, the order and quality‑safety of pharmaceutical operations—and establish clear standards governing the prolonged suspension of business and the resumption of operations by wholesale pharmaceutical enterprises, retail chain headquarters, and retail pharmacies.

Related Reading: http://nxyjj.nx.gov.cn/zwgk/gkml/zcwj11/gzwj_37845/ypltjdglc/202509/t20250929_5043830.html

Ningxia: The “Detailed Rules for Drug Online Listing in the Ningxia Hui Autonomous Region (Trial)” will take effect on November 1.

The “Detailed Rules for Drug Online Listing in the Ningxia Hui Autonomous Region (Trial)” issued by the Ningxia Hui Autonomous Region Medical Insurance Bureau has been in effect since November 1. With regard to filing‑based procurement management, it is stipulated that drugs procured through the filing process shall adhere to the principle of “whoever files, whoever procures”; the total value of drugs procured via this mechanism at each medical institution shall not exceed 1% of its annual drug procurement budget, and the number of such items shall not exceed 5% of its standard stock of essential medicines (drugs subject to national medical insurance catalog negotiations during the contract period are excluded).

Related Reading: https://ylbz.nx.gov.cn/zfxxgk/fdzdgknr/tzgg/202509/t20250925_5037114.html (This article is reprinted from China Pharmaceutical News.)