What drugs are included in the business scope of medical herbal therapy preparations?

Judging from the current unified requirements of domestic drug supervision and market supervision, the core categories included in the business scope of medical herbal therapy preparations are herbal Chinese patent medicines that have obtained the Z batch number of the National Drug Approval, Chinese medicine pieces that comply with local processing standards, Chinese medicine formula granules that have been approved by the state, and herbal medical dressings and external preparations that have obtained Class I and Class II medical device qualifications.

A while ago, I helped a friend who runs a community Chinese medicine clinic go through the procedures for changing the business scope, and I discovered that many practitioners are not clear about the boundaries of this category, and there is even a lot of controversy in the industry. When my friend first submitted the materials, he filled in this category the Xiaozihao herbal antibacterial ointment that is often used by customers in the store, and the Zhuangzihao herbal hand cream sold in conjunction with it. He was immediately called back by the window. The staff made it clear that these two categories did not belong to the category of medical drugs or medical devices, and they definitely could not be counted.

There are actually two different opinions on the definition of this scope. Many practitioners who open physiotherapy centers and health care centers believe that as long as they are products with herbs as the core raw materials and indeed have medical auxiliary effects, even antibacterial products from Xiaozihao and herbal conditioning recipes with the same origin as medicine and food can be classified into this category.； However, the regulatory authorities and the more rigorous practitioners of traditional Chinese medicine centers are convinced that the word "medical" is stuck in the core. All products included in this business scope must obtain formal approval qualifications for drugs or medical devices. Otherwise, herbal products under ordinary consumer brands, makeup brands, and food brands, no matter how effective they are, cannot be counted. If they are rashly included in this category, it is easy to fall into the trap of operating outside the scope.

I have heard before that a colleague who owns a shoulder and neck physiotherapy shop sold herbal dehumidifiers under the Shi brand within this business scope. After complaints from customers, it was found to be an out-of-scope operation and he was fined less than 20,000 yuan. The gain outweighed the loss. If you are really not sure whether your product can enter this scope, it is recommended to go to the local market supervision and drug supervision department with the complete set of qualification documents of the product in advance to ask for clarification. After all, the supervision standards in different places occasionally have subtle differences. For example, some prefecture-level cities will also relax access to compliant herbal conditioning products in the medicinal and food homologous catalogs, while some places are extremely strict. It never hurts to ask in advance.