Shenzhen Introduces GPO Implementation Rules: Non-compliant Pharma Companies to Be Blacklisted

The Shenzhen Municipal Health and Family Planning Commission recently issued the "Administrative Measures for the Group Procurement Catalog of Drugs in Shenzhen Public Hospitals (Trial)" (hereinafter referred to as the "Group Procurement Catalog"), the "Administrative Measures for the Organization of Group Procurement of Drugs in Shenzhen Public Hospitals (Trial)" (hereinafter referred to as the "Group Procurement Organization"), and the "Regulations on Group Procurement of Drugs in Shenzhen Public Hospitals (Trial)" (hereinafter referred to as "Group Procurement"). These documents serve as supporting measures for the pilot reform program of "group purchasing" of drugs in public hospitals, providing detailed explanations on organization selection, supervision, drug production, and distribution. Non-compliant enterprises will be blacklisted and barred from future selection processes.

In accordance with the "Group Procurement Organization," the municipal health administrative department, in conjunction with the municipal finance, market regulation, human resources and social security, and public hospital management departments, shall establish a Selection Committee responsible for selecting the Group Procurement Organization. The Group Procurement Organization shall hold valid "Drug Operation License" and "Good Supply Practice (GSP) Certificate for Pharmaceuticals," possess the capability to procure all drugs listed in the "Group Procurement Catalog," and maintain an online pharmaceutical supply platform capable of meeting functional requirements such as drug information storage and analysis, order integration, contract management, procurement transactions, settlement and payment, distribution management, and collection of adverse drug reaction information.

In accordance with procedures including the formulation of selection plans, issuance of selection announcements, qualification reviews, selection and result confirmation, and public notification of selection results, the group purchasing organization is selected annually. Based on scoring rankings, the municipal health administrative department designates one institution as the group purchasing organization.

In accordance with the Group Procurement Catalog, priority in drug selection shall be given to drugs that align with clinical pathways and are included in the coverage for major diseases, the National Major New Drug Innovation Program, major public health projects, and the Medical Insurance Catalog. This includes drugs ranked within the top 80% by total procurement value on the Guangdong Provincial Electronic Drug Trading Platform by all public hospitals in the city during the previous year, as well as commonly used low-priced drugs, specialty drugs for women and children, emergency and rescue drugs, and drugs with market supply shortages.

Drugs excluded from the scope of the "Group Procurement Catalog" include: narcotic drugs, Class I psychotropic substances, medicinal toxic drugs, and radioactive drugs under special state management, as well as traditional Chinese medicinal materials and prepared slices.

The "Group Procurement Catalog" stipulates that for drugs with the same generic name, there shall be no more than two varieties each for injectable and oral dosage forms, and one to two varieties of compound preparations with similar prescription compositions.

This article was reposted by VCBeat (WeChat Official Account: vcbeat) from Shenzhen Special Zone Daily.