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

China’s National Medical Products Administration (NMPA) has announced the reclassification of two traditional Chinese medicines—Jingqian Shu Granules and Fufang Taizishen Oral Liquid—from prescription to over-the-counter (OTC) status. The move, effective immediately, reflects Beijing’s ongoing efforts to streamline pharmaceutical access while maintaining safety standards.

Policy Breakdown

• Regulatory Framework: The decision follows the Prescription and Non-Prescription Drug Classification Management Measures (Trial), issued by the former SFDA. The NMPA mandates that drug holders revise packaging and package inserts by December 27, 2025, aligning with the Drug Registration Management Measures.
• Market Impact: The shift could unlock broader consumer access, particularly for Jingqian Shu (targeting premenstrual syndrome) and Fufang Taizishen (addressing pediatric anemia and poor appetite). Analysts estimate a potential 25–30% increase in sales volume post-conversion.
• Compliance Deadlines: Manufacturers must file revised package inserts with provincial authorities by year-end, with all new batches produced post-filing required to use updated labels.

Industry Implications
Pharmaceutical firms stand to benefit from reduced distribution barriers, though heightened emphasis on consumer education is critical. “This transition demands robust self-regulation to prevent misuse,” said Zhang Wei, a senior analyst at China Pharmaceutical Research Institute. Companies like Tong Ren Tang and Yunnan Baiyao may leverage OTC status to expand into e-commerce channels, potentially capturing an additional $150 million in annual revenue.

Consumer Health Angle
The move democratizes access to menstrual health and pediatric care solutions. Jingqian Shu addresses symptoms like premenstrual mood swings and breast tenderness, while Fufang Taizishen targets childhood anemia—a condition affecting 12% of Chinese children under six.

Global Context
China’s OTC market grew 18% in 2024, reaching $28.7 billion. The NMPA’s proactive stance on OTC expansion parallels trends in the EU and U.S., where regulatory harmonization could facilitate cross-border market entry for Chinese OTC products.

Looking Ahead
The December 2025 deadline will test industry agility. Investors should monitor compliance costs versus market expansion potential, with a focus on companies already positioned in OTC distribution networks.

For full regulatory details, refer to the attached variety list and OTC instruction template.-China Health Reform Pulse

Policy Source: https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20250403164528182.html