The General Office of the National Health Commission (NHC), the Office of the National Healthcare Security Administration (NHSA), the General Office of the National Administration of Traditional Chinese Medicine, and the General Office of the National Disease Control and Prevention Administration jointly issued the “Notice on Further Improving the Safe and Rational Deployment and Use of Innovative Drugs”, setting out requirements in four areas to promote the safe and rational deployment and use of innovative drugs and meet the people’s diversified medication needs — a coordinated policy push to shorten the path from national reimbursement listing to actual hospital use.
Contents
Policy Snapshot
| Item | Detail |
|---|---|
| Issuing Bodies | NHC General Office; NHSA Office; National Administration of TCM General Office; National Disease Control and Prevention Administration General Office |
| Document | “Notice on Further Improving the Safe and Rational Deployment and Use of Innovative Drugs” |
| Issue Date | 30 October 2026 |
| Scope | Four requirement areas: rational deployment; training and guidance; conditions for use; management measures |
| Key Lists | Category 1 innovative drugs on the National Reimbursement Drug List (NRDL) and the Commercial Health Insurance Innovative Drug List (CHIIDL) — jointly the “Two Lists” |
Requirement 1 – Promoting Rational Deployment
- Hospital Formulary Access: Secondary and higher‑level medical institutions must optimize procedures and workflows for introducing innovative drugs, promptly convene Pharmacy Administration and Therapeutics Committee meetings, and promptly include relevant innovative drugs in institutional medication catalogues based on service capabilities and clinical needs.
- Demonstration by Major Hospitals: Provincial‑level and higher hospitals and prefecture‑level hospitals should play a demonstrative and leading role step by step, including — under the principle of active and standardized deployment — Category 1 innovative drugs from the Two Lists they have the capability and conditions to use.
- Consortium Linkage: Close‑knit medical consortia should dynamically adjust medication catalogues, with member institutions deploying Two Lists Category 1 innovative drugs as needed, promoting medication linkage between primary and higher‑level institutions.
- Beyond the Two Lists: Institutions are encouraged to include other innovative drugs in their catalogues based on actual circumstances.
Requirement 2 – Strengthening Training and Guidance
- Systematic Training: Provincial and municipal health administrative departments must regularly organize industry experts and pharmaceutical companies to train on medication knowledge and medical insurance payment policies for newly added Two Lists drugs, covering at least prefecture‑level and higher hospitals in their jurisdictions.
- Expert Consensus Timeline: Phase III clinical trial lead hospitals are encouraged to draft expert consensus on clinical use, to be published within six months after the relevant Category 1 innovative drugs are included in the Two Lists.
- Guideline Integration: The NHC will strengthen collection of clinical use information on Two Lists Category 1 innovative drugs and promptly include drugs with sufficient evidence‑based medical evidence in clinical diagnosis and treatment guidelines, and will focus on relevant drugs in its prescription spot‑check work.
Requirement 3 – Optimizing Conditions for Use (Payment Mechanisms)
- Special Case Single‑Case Review: For rational use of NRDL innovative drugs not suitable for disease‑specific payment standards (e.g., DRG/DIP‑style bundled payments), medical institutions are supported in independently applying for special case single‑case review.
- Review Cadence: Medical insurance departments should simplify procedures and optimize processes, organizing expert review of special case submissions quarterly or monthly, then implementing fee‑for‑service payment for relevant cases or adjusting payment standards based on review results.
- CHIIDL Carve‑Out: Cases using drugs from the CHIIDL may be excluded from the scope of medical insurance disease‑specific payment and paid after review and assessment procedures — insulating hospitals from bundled‑payment losses when prescribing high‑value commercial‑insurance‑list drugs.
Requirement 4 – Improving Management Measures
- No Variety Caps: Local health administrative departments shall not impose restrictions on the total number of drug varieties and specifications in medical institutions; Two Lists Category 1 innovative drugs shall not be counted toward the “one variety, two specifications” rule.
- KPI Exemptions: Two Lists Category 1 innovative drugs are excluded from public medical institution performance monitoring indicators, including: proportion of essential medicine prescriptions for outpatients; utilization rate of essential medicines for inpatients; proportion of essential medicine procurement varieties; growth rate of average outpatient drug costs; and growth rate of average inpatient drug costs.
- Systems Upgrade: Local authorities should guide institutions to improve information systems and optimize internal management systems accordingly.
Market Impact & Outlook
- Closing the “Last Mile”: The notice directly targets the historic bottleneck between NRDL inclusion and hospital formulary adoption, using committee convening mandates, KPI exemptions, and payment carve‑outs to align hospital incentives with innovative drug access.
- Commercial Insurance Channel Validation: By extending deployment and payment protections to the CHIIDL, the four agencies reinforce the NRDL + commercial insurance “Two Lists” architecture as the dual‑track access pathway for high‑value innovative drugs in China.
- Pharma Commercial Upside: For innovators with Category 1 drugs on either list, faster formulary inclusion, six‑month expert consensus timelines, and guideline integration compress the post‑listing revenue ramp — improving the commercial return on NRDL negotiation pricing.
- Hospital Economics Protected: Special case single‑case review and CHIIDL exclusion from disease‑specific payment shield hospitals from financial penalties for rational high‑cost prescribing, removing a key structural barrier to innovative drug uptake.
- Watchpoints: Implementation will depend on provincial‑level execution, the cadence of special‑case reviews, and whether prescription spot‑checks and consensus documents translate into measurable uptake of Two Lists products.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding implementation of the Notice, hospital adoption of NRDL and CHIIDL innovative drugs, payment mechanism adjustments, and the commercial outlook for listed products. Actual results may differ due to risks including provincial execution variability, medical insurance fund constraints, formulary committee decisions, and subsequent policy adjustments.-Fineline Info & Tech
