What this pathway is
Boao Lecheng provides a controlled route under which a qualified medical institution may apply to use a selected clinically needed imported drug or medical device. The product, institution, intended purpose, clinical need, application materials, and official procedure all matter. The responsible medical institution must follow the applicable controls for procurement, use, monitoring, follow-up, and traceability.
Who may find it relevant
An overseas drug or medical-device team may consider an assessment when its product has relevant overseas status, a credible clinical-use question exists, and a qualified institution independently identifies a clinical need. Those facts are inputs for review, not proof of eligibility or institutional interest.
What it does not provide
Lecheng use is not Mainland China marketing authorization and does not create general distribution permission. Permission for one product, institution, or purpose does not establish permission elsewhere.
Scientifically designed research using relevant, reliable, and quality-controlled real-world data may generate supporting real-world evidence for clinical evaluation of an eligible product. It does not replace NMPA review, determine what other evidence is required, or guarantee approval.
Questions to assess
- What is the product’s current overseas approval and use status?
- What specific clinical need would a qualified institution need to identify?
- Does the proposed product, indication or scope, institution, and use plan fit the current procedure?
- What supply, traceability, monitoring, consent, and follow-up responsibilities would apply?
- Is a real-world study scientifically justified, and how would its data complement the broader evidence package?
- What national-registration questions remain separate from special access?