The National Medical Products Administration (NMPA) today issued the “Measures for the Administration of Drug Quality Sampling and Inspection (Draft for Comment)” and is inviting public feedback until November 5, 2025. The draft outlines a comprehensive, multi‑tiered framework for sampling and inspection across the entire drug supply chain—from production to retail, including online sales platforms.
Scope of the Draft Measures
- Provincial Responsibility – Provincial drug regulatory departments will organize and implement sampling and inspection in their jurisdictions, covering:
- Production links (finished‑product warehouses, raw‑material and packaging‑material warehouses)
- Distribution links (wholesale warehouses, retail chain headquarters, third‑party online platforms)
- Usage links (retail drug storerooms).
- City‑County Level Work – District‑city and county‑level drug regulatory departments will conduct inspections at retail and use links and carry out tasks delegated by higher authorities.
Sampling Methodology
| Link | Typical Sampling Locations | Key Rules |
|---|---|---|
| Production | Finished‑product warehouse; raw‑material & excipient warehouses | Sample only drugs released into the warehouse and pending sale; exclude “pending inspection,” “non‑conforming,” or “returned” products. |
| Distribution | Enterprise drug warehouse; retail premises | Same rules as production. |
| Usage | Drug storeroom | Same rules as above. |
Online Sampling Protocol
- Purchase Without Disclosure – The sampling unit or individual must not reveal the sampling purpose to the online seller.
- Prescription Drugs – May request a medical institution to issue a prescription for the purchase.
- Verification – Prior to sampling, verify the seller’s qualifications and compliance on the platform.
- Evidence Capture – Preserve screenshots, photos, or videos of the product listing, platform interface, and transaction records.
- Sample Handling – Store samples under conditions that maintain integrity for laboratory analysis.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech
