A traditional Chinese medicine practitioner introduces the wide range of TCM materials. Photo: cnsphoto

A Chinese media report highlighting a regulation that will deny re-registration for any Traditional Chinese Medicine (TCM) product still listing "unclear" under contraindications, adverse reactions, or precautions, effective July 1 of this year, has sparked public discussion regarding the necessity of addressing safety risks in the industry.

According to the report by 21st Century Business Herald on Tuesday, numerous traditional Chinese patent medicines may face market withdrawal due to the regulation. Chinese patent medicines are mass-produced in modern factories using herbal materials, guided by TCM theory, and adhering to prescribed formulations and processes.

In 2023, China released a regulation on the registration and administration of TCM, one provision of which requires marketing authorization holders to strengthen the full life-cycle management of medicines, enhance the monitoring, evaluation, and analysis of safety risks, and update TCM labeling — particularly the contraindications, adverse reactions, and precautions sections — according to relevant technical guidelines. 

Furthermore, the regulation stipulates that any TCM whose labeling still states "unclear" in any of these sections when applying for re-registration three years after the regulation takes effect—which will be July 1 of this year—will be legally denied re-registration.

The report by 21st Century Business Herald noted that this reflects a regulator-driven effort to clean up the Chinese patent medicine industry, signaling that it has entered a critical phase. Central to this new policy is the aim to end the long-standing practice of "unclear" labeling in Chinese patent medicine instructions, compelling marketing authorization holders to address gaps in post-marketing safety data, the report said. 

As of Wednesday evening, the topic concerning the potential withdrawal of a number of Chinese patent medicines was trending on China's social media platform Sina Weibo, drawing at least 40 million views. Some netizens commented that the regulation will phase out Chinese patent medicines with incomplete or non-standard data, emphasizing that patients shouldn't pay the price for unclear safety information. Some users also said that this regulation will push the industry to improve drug safety standards and is expected to trigger a major market reshuffle.

However, there are also online voices expressing concerns about the TCM products they regularly use, worrying that the regulation may lead to the loss of medicines they find effective.

Luo Chaofan, a rehabilitation therapist at the National Health Commission, told the Global Times on Wednesday that the higher requirements for TCM are necessary, as they will standardize the development of the industry and lay a more robust and proactive foundation for its future development. 

While acknowledging the possibility that some traditional Chinese patent medicines may exit the market, the expert stated that there is inevitably an adaptation period during the early stages of industry transformation. He added that only after passing through the initial phase and progressing into later stages of development can better standardization be achieved.

As part of continued oversight, a special provision on the supervision and administration of TCM production, which will take effect on March 1 of this year, further tightens requirements for the processing, packaging, and labeling of TCM decoction pieces.

According to a report by Xinhua on March 20, 2025, the general office of China's State Council released a set of guidelines on improving the quality of TCM and advancing the high-quality development of the TCM industry.