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

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.

Contents

Policy Framework
Eligibility Criteria
Assessment Process
Strategic Implications & Industry Impact
Competitive Dynamics

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Policy Framework

Element	Detail
Issuing Authority	National Healthcare Security Administration (NHSA)
Policy	Reference Drugs Pre-communication Measures (Trial)
Effective Date	10 Feb 2026 (immediate effect)
Mechanism	Voluntary company applications → Expert assessment → Reference drug designation
Purpose	Enable pharmacoeconomic studies and real-world evidence generation for reimbursement

Eligibility Criteria

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

Assessment Process

Step	Activity	Timeline
Application Submission	Companies submit voluntary applications to NHSA	Rolling basis
Expert Assessment	NHSA Medicine Pricing and Bidding Procurement Guidance Center organizes periodic reviews	Monthly cycle (applications accepted by end of previous calendar month)
Reference Drug Designation	Expert panel determines reference drug and main specifications	Post-assessment
Evidence Generation	Companies conduct pharmacoeconomic and real-world studies using designated reference	Post-designation

Strategic Implications & Industry Impact

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

Competitive Dynamics

Stakeholder	Strategic Response
Multinational Pharma	Accelerate China-first launch strategies; leverage global RWE for reference drug applications
Domestic Innovators	Priority access to NRDL pathway for Category 1 assets; competitive advantage vs. non-innovative competitors
HTA Consultants	Increased 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

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

Policy Framework

Eligibility Criteria

Assessment Process

Strategic Implications & Industry Impact

Competitive Dynamics

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