Beijing, Aug 31, 2026 — China’s National Medical Products Administration (NMPA) converted Yumei preparations from over-the-counter (OTC) medicines to prescription-only drugs, citing public safety concerns and ordering marketing authorization holders to submit supplemental applications for revised labeling and safety information by Nov 30, 2026.
Regulatory Snapshot
| Attribute | Detail |
|---|---|
| Issuer | National Medical Products Administration (NMPA) |
| Announcement | 2026 No. 83 |
| Action | Conversion of Yumei preparations from OTC to prescription drugs |
| Legal basis | Measures for the Classification Management of Prescription and OTC Drugs (Trial) (former NMPA Order No. 10) |
| Supplemental application deadline | Nov 30, 2026 |
| Labeling replacement period | 9 months after supplemental approval |
| Scope | All Yumei preparation products listed in Annex 1 |
Key Requirements
Marketing authorization holders must file supplemental applications with the NMPA Center for Drug Evaluation by the November deadline to revise product labeling. Safety information must be updated per Annex 2 specifications, while all other labeling content must be adjusted to meet prescription drug standards. Product labels must be revised concurrently.
Once the supplemental application is approved, holders have nine months to replace instructions and labels on all products already released to market, or to inform patients through alternative means. The NMPA also mandated strengthened adverse event reporting, risk control, and pharmacovigilance obligations.
Clinical and Distribution Restrictions
Manufacturers, distributors, and clinical users must now treat Yumei preparations as prescription-only products, complying with all applicable prescription drug management requirements. Physicians and pharmacists must conduct thorough benefit-risk analyses based on the revised prescribing information when selecting these medicines. Patients are required to strictly follow medical advice.
Provincial drug regulators are instructed to supervise local holders in completing labeling revisions and replacements, and to severely investigate and punish violations.
Market Impact Analysis
The reclassification immediately restricts Yumei preparations to pharmacy counters requiring valid prescriptions, eliminating over-the-counter self-selection and impulse purchases. For retail pharmacy chains, the shift demands operational adjustments including staff retraining, prescription verification system upgrades, and inventory segregation. The nine-month labeling replacement window provides a transition period but imposes logistical and printing costs on manufacturers.
The safety-driven conversion signals heightened NMPA scrutiny of cough and cold preparations with abuse potential or adverse event profiles that warrant tighter medical supervision. Yumei product volumes are likely to contract as consumer accessibility drops, though clinical demand through hospital and clinic channels may partially offset retail losses.
Forward-Looking Statement
Industry analysts expect the NMPA to evaluate additional OTC respiratory or combination preparations for similar reclassification before year-end, particularly those containing centrally acting ingredients. Retail pharmacies should prepare for a broader tightening of OTC categories by reinforcing prescription dispensing infrastructure and pharmacist consultation capabilities. Marketing authorization holders with significant Yumei exposure face a compressed timeline to complete supplemental filings and should budget for nationwide labeling replacement campaigns in the first half of 2027.-China Health Reform Pulse
Policy Source: https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20260901100027146.html