Recently, the State Food and Drug Administration (SDA) publicly solicited comments on the technical guidelines for revising the safety Information items of the Listed Chinese medicine (HEREINAFTER referred to as the "Draft"). The Draft for Comments pointed out the problems of insufficient or missing contents of safety information items in the instructions of marketed Chinese medicines, and provided basic ideas and methods for revising the contents of safety information items such as warnings, adverse reactions, contraindications, precautions and medication for special groups. At the same time, the draft notes stressed "timely, objective and truthful presentation of drug safety information", indicating that if relevant research results are available, the corresponding safety information items should not be marked "unclear".

　　The draft puts forward the basic principles that should be followed in the revision of listed TCM instructions, namely, theoretical guidance of TCM, whole-life cycle management and scientific, standardized and accurate expression. The relevant content points out that the expression of disease names, TCM syndromes, pharmaceutical terms, drug names, physical and chemical examination items and results should adopt special terms issued or standardized by the state, and the units of weights and measures should conform to the provisions of the national standards. It shall not contain suggestive, misleading or inappropriate propaganda language.

　　For the warnings of traditional Chinese medicine instruction, Adverse reactions, Contraindications , Precautions and Medication for special people, the focus of the revision is different. The "draft" detailed respectively, listing the common situation of warnings, presenting data , information and relevant factors on the revision basis of adverse reactions .With regard of disease contraindications, contraindications of special groups, contraindications of combined drug use and other contraindications, this draft elaborated how to limit the situations that may cause serious harm in Contraindications item, analyzed the aspects that should be considered in the revision of Precautions item, and explained the requirements related to drug use for special groups. "Draft" also pointed out that as for imported Chinese medicine and natural medicine, the content in the safety information item of instructions should be the same as the original instructions and be updated synchronously. Also, the adverse reactions monitoring and the relevant safety information found in the evaluation after going into market should added to the instructions.

　　Drug instructions are important technical data to express the efficacy and safety of drugs, which can lead to the clinicians' rational drug use, pharmacists’ pharmaceutical care and patients' safe drug use. For some Chinese medicines that have been on the market for many years ,the safety information items in the instructions are missing and adverse reactions, contraindications and precautions are often described as "unclear", which affects safe and rational drug use. In recent years, the National Drug Regulatory Authorities attach great importance to the management of the instructions of Chinese patent medicine , actively promote the revision of the safety content of drug instructions. Only in 2020 it issued 14 issues of revision announcement of Chinese patent medicine involving 45 types of Chinese patent medicine. In December 2020, SFDA issued the Implementation Opinions on Promoting the Inheritance, Innovation and Development of Traditional Chinese Medicine, which clearly strengthened the management of TCM instructions and labels, and promoted the revision and improvement of Contraindications, Adverse reactions, Precautions and other relevant contents in the instructions of marketed TCM.