Analysis: New Safety Rules Unlikely to Trigger Mass Delistings of Chinese Traditional Medicines

1. A new Chinese regulation requires pharmaceutical companies to explicitly list safety risks—such as contraindications, adverse reactions, and precautions—on the labels of traditional medicines. Although this has raised concerns about a potential mass withdrawal of products from the market, industry insiders suggest that the rule will mostly impact inactive or dormant "zombie" products while leaving most popular remedies available. The crackdown aims to eliminate vague disclaimers that previously allowed companies to label certain risks as "unclear." [para. 1][para. 2]

2. The policy, known as the Provisions on the Administration of Traditional Chinese Medicine Registration, took effect on July 1, 2023. Under the rule, if product safety information remains unclear by the time of the medication’s five-year renewal—starting mid-2026—regulators will deny the renewal. Historically, many herbal drug manufacturers bypassed providing detailed safety disclosures by using the phrase “shangbu mingque” (“unclear”) on labels. For example, a 2025 study of 142 TCM products at one Chinese hospital found that nearly 45% listed their contraindications and adverse reactions as “unclear.” [para. 2][para. 3]

3. Despite the widespread practice of vague labeling, experts believe the new requirement does not pose a serious threat to the industry. Most companies are actively working on or have completed the mandated updates. Many believe that only old products with inactive licenses—those not manufactured for years—will be eliminated, while the majority of current market products will remain unaffected. [para. 4][para. 5]

4. Compliance with the regulation is described as straightforward and low-cost. Regulatory specialists explain that many companies have proactively started to update their safety disclosures, and for those with professional in-house teams, the process is relatively simple. Manufacturers usually do not need expensive new clinical trials for oral TCM products; they can use existing data from the National Center for ADR Monitoring, scientific literature, and post-market clinical research. [para. 6][para. 7][para. 8]

5. Companies are encouraged to broadly disclose adverse reactions, even when mentioned only indirectly in available data. Contraindication and precaution sections can be updated using traditional knowledge and existing safety data, unless regulators request specific toxicology reports. For most products with established market history, no additional trials are needed. [para. 9]

6. The timeline for updating labels is relatively short—typically three to six months if the necessary data are available. However, products lacking a recent production history may require new studies, making compliance costly and possibly prompting companies to abandon such products. [para. 10]

7. The pricing for compliance services has significantly decreased—from hundreds of thousands of yuan in 2023 to about 20,000–30,000 yuan ($2,780–$4,170) per product today. Some companies are negotiating bulk deals to update multiple products cost-effectively. [para. 11]

8. Regulatory data reflect a steady rise in supplementary applications for TCM updates: 2,655 in 2023, 2,672 in 2024, and 3,276 in 2025, mostly for label revisions, even among highly competitive, low-margin products. [para. 12]

9. This move toward transparency aligns with Beijing’s broader efforts to modernize the traditional medicine sector. Over two decades, regulators have issued 160 announcements about TCM label revisions, with the pace accelerating. Notably, in March 2025, a mandatory "black box" warning was required for Yanhuning, an herbal injection, prohibiting its use in young children. [para. 13]

10. Beyond labeling, the industry faces growing pressure to demonstrate efficacy through real-world studies, especially as medical insurance increasingly favors drugs with proven effectiveness. Some major companies are already investing in research to justify the clinical benefits of their signature products. [para. 14]

11. On January 27, new regulations were published that will take effect May 15, explicitly requiring post-market evaluations. Drug license holders must update labels, improve quality, or withdraw products if risks are found to outweigh the benefits. [para. 15]

12. Ultimately, while the demand for explicit safety information means the era of "unclear" risks is ending for TCM products, the industry's main players are adapting well to the new regulatory landscape. [para. 16]