China’s drug regulator has put traditional patent medicines on notice: products whose package inserts still list adverse reactions, contraindications or precautions as “not yet clear” risk losing their approvals when they come up for re‑registration. The rule — Article 75 of the Ministry’s Specialized Provisions on Traditional Chinese Medicine Registration, which took effect on 1 July 2023 and begins to bite after a three‑year grace period — requires firms to fill those safety‑information gaps or be refused re‑registration.
The change targets a long‑standing feature of many Chinese proprietary medicines: terse inserts that declare key safety items “尚不明确” (“not yet clear”). That phrasing became an accepted shorthand in official guidance first issued in 2006, and by some estimates has been used in a majority of legacy products. A 2025 study of 1,424 formulae found that more than half listed adverse reactions as unclear, and roughly 40–50% used the same wording for contraindications and precautions.
Regulatory and industry sources link the problem to historical approval practices. In the 1990s and early 2000s, provincial authorities approved many preparations to support local industries; later, when approvals were centralised, many of those provincial licences were upgraded to national status without modern clinical‑trial dossiers. Analysts describe a large stock of “zombie approvals” — licences that exist on paper but correspond to products no longer widely produced or clinically substantiated.
The numerical scale complicates the task. Official workbooks list about 57,000 effective approval numbers as of May 2023, while other authorities count roughly 9,000 distinct patented formulas produced by some 2,400 manufacturers. Regulators say the clean‑up will prune duplicate, low‑use and low‑value entries while forcing manufacturers to supply safety data for commercially important lines.
Industry reaction has been measured. Academics and veteran reviewers argue the requirement mainly forces long overdue catch‑up: large, active producers already have the resources and will to compile adverse‑event data or run post‑marketing studies. Smaller companies and marginal product lines, by contrast, may be withdrawn or consolidated; mergers, transfers of approvals and industry rationalisation are expected to accelerate.
The policy signals a shift from quantity to quality. Officials frame Article 75 as a life‑cycle regulatory tool: re‑registration is not a blunt elimination but a push to complete dossiers and demonstrate safety across a drug’s market presence. Observers also note a secondary motive: aligning public insurance spending with treatments that have firmer evidence, thereby containing medical insurance costs.
Timing matters for market incumbents. Registration certificates run on five‑year cycles, and firms have been advised to file re‑registration dossiers six months before expiry. Some companies have already quietly prepared files to extend approvals through the mid‑2020s, but a systemic cull is likely to intensify from 2026, with analysts forecasting substantial completion by about 2030. New TCM products already face far stricter clinical requirements, including phase‑based trials, underscoring the divide between legacy and contemporary approvals.
For international observers, the episode is instructive about China’s approach to industrial upgrading: regulators are using administrative deadlines and data demands to reshape an industry that straddles medicine, culture and local economic protection. The outcome will matter for patients who rely on familiar remedies, for multinational drugmakers watching market consolidation, and for Beijing’s stated ambition to raise standards in a strategically important sector.