NMPA Releases Draft Measures on Drug Quality Sampling, Seeks Public Comments by Nov 5

NMPA Releases Draft Measures on Drug Quality Sampling, Seeks Public Comments by Nov 5

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

LinkTypical Sampling LocationsKey Rules
ProductionFinished‑product warehouse; raw‑material & excipient warehousesSample only drugs released into the warehouse and pending sale; exclude “pending inspection,” “non‑conforming,” or “returned” products.
DistributionEnterprise drug warehouse; retail premisesSame rules as production.
UsageDrug storeroomSame rules as above.

Online Sampling Protocol

  1. Purchase Without Disclosure – The sampling unit or individual must not reveal the sampling purpose to the online seller.
  2. Prescription Drugs – May request a medical institution to issue a prescription for the purchase.
  3. Verification – Prior to sampling, verify the seller’s qualifications and compliance on the platform.
  4. Evidence Capture – Preserve screenshots, photos, or videos of the product listing, platform interface, and transaction records.
  5. 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