Policy / Regulatory

China’s NHSA Launches Reference Drug Pre-Communication System to Streamline Reimbursement Pathway

By Fineline Cube #NHSA (prev. SMIA)

The National Healthcare Security Administration (NHSA) has released the “Reference Drugs Pre-communication Measures (Trial)”, establishing a voluntary expert assessment mechanism to recommend reference drugs for pharmacoeconomic studies and real-world research. The policy, effective immediately, targets Category 1 innovative drugs approved or under review by the NMPA since 2021, aiming to accelerate evidence generation for National Reimbursement Drug List (NRDL) negotiations and market access decisions.

Policy Framework

ElementDetail
Issuing AuthorityNational Healthcare Security Administration (NHSA)
PolicyReference Drugs Pre-communication Measures (Trial)
Effective Date10 Feb 2026 (immediate effect)
MechanismVoluntary company applications → Expert assessment → Reference drug designation
PurposeEnable pharmacoeconomic studies and real-world evidence generation for reimbursement

Eligibility Criteria

CategoryRequirement
Drug ClassificationCategory 1 chemical drugs; Category 1 therapeutic biologics; Category 1 traditional Chinese medicines
Condition ①NMPA marketing approval after January 1, 2021 (within 5 years)
Condition ②Significant indication expansion approved by NMPA after January 1, 2021
Condition ③Pre-approval status: Marketing application accepted and passed technical review (requires clinical trial approval notice or domestic trial exemption proof)

Assessment Process

StepActivityTimeline
Application SubmissionCompanies submit voluntary applications to NHSARolling basis
Expert AssessmentNHSA Medicine Pricing and Bidding Procurement Guidance Center organizes periodic reviewsMonthly cycle (applications accepted by end of previous calendar month)
Reference Drug DesignationExpert panel determines reference drug and main specificationsPost-assessment
Evidence GenerationCompanies conduct pharmacoeconomic and real-world studies using designated referencePost-designation

Strategic Implications & Industry Impact

FactorMarket Analysis
NRDL PreparationReference drug designation streamlines health technology assessment (HTA) process, reducing negotiation preparation time by 6-12 months
Innovation IncentiveTargets Category 1 drugs—China’s highest innovation tier—reinforcing policy preference for novel therapies over generics
Real-World Evidence (RWE) ValidationFormalizes RWE acceptance in reimbursement decisions, aligning China with US FDA and EU EMA trends
Pre-Approval EngagementCondition ③ allows pre-launch dialogue for pipeline assets, enabling proactive evidence generation and pricing strategy development
Pharmacoeconomic StandardsReference drug establishment promotes methodological consistency across company submissions, reducing assessment variability

Competitive Dynamics

StakeholderStrategic Response
Multinational PharmaAccelerate China-first launch strategies; leverage global RWE for reference drug applications
Domestic InnovatorsPriority access to NRDL pathway for Category 1 assets; competitive advantage vs. non-innovative competitors
HTA ConsultantsIncreased demand for pharmacoeconomic modeling and real-world study design services
Payers (NHSA)Enhanced negotiation leverage through standardized reference pricing; improved budget impact predictability

Forward‑Looking Statements
This brief contains forward‑looking statements regarding NHSA reference drug assessment implementation timelines, NRDL negotiation outcomes for designated products, and real-world evidence acceptance standards in China. Actual results may differ due to expert panel composition variability, reference drug selection criteria evolution, and integration challenges with existing NRDL evaluation workflows.-Fineline Info & Tech

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