By Fineline Cube The National Medical Products Administration (NMPA) announced a decision to carry out quality and efficacy conformance evaluations for chemical drugs in dosage forms beyond oral solid preparations and injections, gradually expanding coverage to eye drops, patches, sprays, and other dosage forms. The move marks the next phase of China’s decade‑long generic drug quality upgrade — with eye drops evaluations initiated immediately, and patches and sprays to follow on July 1, 2027.
Policy Implementation Timeline
| Item | Detail |
|---|---|
| Issuing Authority | National Medical Products Administration (NMPA) |
| Policy Scope | Quality and efficacy conformance evaluations for chemical drugs in non‑oral‑solid / non‑injection dosage forms |
| Dosage Forms Covered (Phased) | Eye drops, patches, sprays, and other dosage forms |
| Eye Drops | Evaluations initiated as of the announcement date (Sept 2, 2026) |
| Patches and Sprays | Evaluations to launch on July 1, 2027 |
| Regulatory Basis | Extension of the existing conformance evaluation framework for generic drugs |
Evaluation Requirements & Clinical Trial Provisions
- General Standard: Generic preparations must demonstrate consistency in quality and efficacy versus reference products, typically through pharmaceutical studies and/or conventional bioequivalence studies
- Complex Varieties Exception: For certain drugs where active pharmaceutical ingredients (APIs) or formulations are complex, pharmaceutical and bioequivalence studies alone may not fully demonstrate equivalence
- Clinical Trial Requirement: In such cases, necessary clinical trials must be conducted to prove quality and efficacy equivalence between generic drugs and reference products
- Regulatory Pathway: Applicants may communicate specific clinical trial protocols with the Center for Drug Evaluation (CDE) through established communication channels
Market Impact & Outlook
- Higher generic bar: Expanding conformance evaluations to complex dosage forms raises the technical threshold for generic manufacturers of eye drops, patches, and sprays — likely accelerating industry consolidation
- Reference‑driven shakeout: Products unable to match reference drugs in quality and efficacy face potential market exit, while compliant generics gain prescribing confidence and procurement eligibility
- Clinical trial burden: The requirement for clinical trials in complex‑formulation cases adds development cost and timelines, favoring technically stronger domestic players with established CDE engagement experience
- Phased predictability: The staggered implementation — immediate for eye drops, 2027 for patches and sprays — gives manufacturers planning runway while signaling the NMPA’s long‑term commitment to full‑dosage‑form conformance coverage
Forward‑Looking Statements — This brief describes a regulatory policy announcement and its potential industry implications. Interpretation of policy requirements and market outcomes involves uncertainty; companies should consult the official NMPA and CDE publications for definitive requirements. No investment decision should be made solely on the basis of this brief.-Fineline Info & Tech