Large quantities of traditional Chinese medicine products will be taken off the market? Adverse reactions and unclear registration, experts say it will not affect the supply of commonly used varieties.

The State Administration for Market Regulation issued the "Special Regulations for the Management of Traditional Chinese Medicine Registration" in February 2023, which will come into effect on July 1, 2023. Article 75 of the Regulations states that if any of the items in the Traditional Chinese Medicine instructions (contraindications, adverse reactions, precautions) are still "unclear" three years after the implementation of these regulations, the drug will not be re-registered according to law. Professor Deng Yong, from the Beijing University of Chinese Medicine, pointed out that earlier regulatory approvals focused on traditional experience and main functions, with lenient safety data requirements. Many varieties were directly marketed based on classical prescriptions, lacking systematic toxicology tests and large-scale clinical trials. In addition, the complexity of traditional Chinese medicine formulas, vague target points, and differences in origins and processing further increase the difficulty of identifying adverse reactions. The post-market evaluation system lags behind, and the drug surveillance mechanism is imperfect, leading to a long-term lack of high-quality safety data, making it difficult to support clear labeling.