The National Joint Procurement Office issued the Announcement on the Information Change Work for Selected Products in National Organization of Drug Volume‑Based Procurement, permitting – when selected enterprises and their drugs meet certain conditions – changes to the Marketing Authorization Holder (MAH), changes to the manufacturer’s name, and applications for supplementary selection, all while retaining their status as selected enterprises.
Contents
Policy Snapshot
| Item | Detail |
|---|---|
| Issuing Body | National Joint Procurement Office |
| Document | Announcement on the Information Change Work for Selected Products in National Organization of Drug Volume‑Based Procurement |
| Issue Date | 23 October 2026 |
| Scope | Selected products of the National VBP (incl. Batches 1–8 renewal and insulin VBP for supplementary selection) |
| Eligible Applicants | Enterprises selected in the National VBP, or enterprises meeting the bidding qualification requirements in the procurement documents of the corresponding batches |
| Paper Submission Deadline | Before 30 October 2026 |
| Submission Window | Service window of the Shanghai Sunshine Medical Procurement All‑In‑One Service Center (Shanghai Pharmaceutical Centralized Bidding and Procurement Management Office) |
| After 30 Oct 2026 | Applications processed via an online platform |
Four Permitted Application Categories
- MAH Changes by Selected Enterprises: Includes changes to the MAH entity – limited to selected enterprises that applied to the medical products administration for changes prior to the time specified in the procurement documents – and changes to the MAH name.
- Entrusted Manufacturer Changes/Additions: Covers changes or additions to the entrusted manufacturing entity, as well as name changes of the entrusted manufacturer – giving CDMO‑based supply chains formal flexibility within VBP contracts.
- Specifications/Packaging Additions: Enterprises may add specifications, packaging quantities, and non‑downgraded packaging methods or materials for selected products. For selected reference formulations, drugs with registration approvals or other equivalent supporting documents proving a continuation relationship with the reference formulation may also apply for addition as selected products.
- Supplementary Selection for Non‑Selected Enterprises: In accordance with the renewal procurement documents for Batches 1–8 of the National VBP and the insulin VBP, eligible enterprises may apply to add non‑selected drugs (including newly approved drugs) as selected products – a formal pathway to bring new entrants into existing VBP award lists.
Application Process & Timeline
- Before 30 October 2026: Enterprises submit written applications and related paper materials through the service window of the Shanghai Sunshine Medical Procurement All‑In‑One Service Center (Shanghai Pharmaceutical Centralized Bidding and Procurement Management Office).
- After 30 October 2026: Change requests transition to an online platform, digitizing the process for ongoing administration of selected‑product information changes.
- Status Retention Principle: Approved changes do not forfeit selected‑enterprise status – continuity of VBP award volume and pricing obligations is preserved through corporate, manufacturing, and packaging changes.
Market Impact & Outlook
- Operational Flexibility for Winners: The policy acknowledges commercial reality – M&A, corporate restructuring, MAH transfers, and CDMO switches are routine in pharma – and removes a major compliance uncertainty by letting selected enterprises restructure without losing VBP award status.
- Supply Security Signal: By formalizing entrusted‑manufacturer changes and non‑downgraded packaging additions, the Office aims to safeguard continuity of supply for volume‑guaranteed products, reducing the risk of contract defaults tied to administrative rather than capacity issues.
- Market Access for Newcomers: The supplementary selection pathway – covering Batches 1–8 renewals, insulin VBP, and newly approved drugs – gives non‑selected and later‑approving products a structured route into national VBP, potentially intensifying competition in already‑awarded categories.
- Digitalization Trend: The shift from paper‑based window submissions to an online platform after 30 October 2026 reflects the broader digitization of China’s centralized procurement administration and lowers the compliance burden for enterprises over time.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the implementation of the information change work for National VBP selected products, including application outcomes, supplementary selection results, and platform transitions. Actual results may depend on the review decisions of the National Joint Procurement Office, enterprise compliance with procurement document requirements, and subsequent policy updates or renewal rounds.-Fineline Info & Tech
