What is the business scope of medical herbal therapy preparations?

At present, the business scope of domestically compliant medical herbal therapy preparations covers three categories that have been registered with the competent authorities, namely non-prescription herbal external-use products registered with the Food and Drug Administration, herbal bacteriostatic preparations with Xiaozi brand, and in-hospital herbal therapy preparations that qualified medical institutions can apply for internal use. Any herbal preparations that are not registered and claim to have the therapeutic effect of prescription drugs are not within the scope of legal business.

Two years ago, when I helped my cousin who opened a physical therapy center in the community to expand his business scope, I encountered many obstacles. At first, he wanted to add the mugwort blood-activating ointment that he had been working on for five or six years to his business project, but was directly rejected by the window. The reason was very simple. The homemade ointment did not have any registration number, and it was neither a mechanical brand nor a consumer product. The brand name was not even registered for ordinary cosmetics, so it could not be classified into the category of medical herbal preparations. Later, we submitted three categories with formal registration, and successfully passed the review. They were herbal acupoint pressure stimulating patches with Class I registration numbers, herbal soothing cold compress gel, and herbal foot antibacterial spray with a small brand name.

There are still many debates about this boundary in the industry. The most prominent one is the operating authority of self-made herbal preparations by traditional Chinese medicine medical institutions. Many experienced traditional Chinese medicine doctors who are deeply involved in clinical practice feel that the external herbal ointments they make in accordance with the provincial traditional Chinese medicine processing regulations are only used by patients in their own clinics and are not circulated to the outside world. They can be included in the business scope. There are also practitioners on the regulatory side who hold different opinions. They believe that as long as they do not obtain a formal approval number for in-hospital preparations, even if they are homemade by medical institutions, they cannot be clearly included in the scope of business. The current implementation standards in different places are actually different. If you really want to do this business, it is best to ask the local drug regulatory and health authorities in advance to avoid stepping on the red line.

If you open an ordinary health service store and are not a medical institution, you will basically not be able to deal with the business scope of in-hospital preparations. At most, you can only add two corresponding categories: sales of medical devices and sales of disinfectants. If you want to produce such preparations, the threshold is higher and you need to obtain a specialized Production qualifications, just like you can't just sell homemade canned milk tea when you open a milk tea shop and distribute it online, the control of medical products will only be stricter. Every category that can be operated must correspond to the registration qualification. You can't just add content to the business license just because you think "herbs are natural and harmless". Oh, by the way, there is another pitfall that many people have stepped on. Many people mix ordinary herbal skin care products into medical herbal preparations. This is also illegal. No matter how many herbal ingredients are added to cosmetic brand herbal products, they do not fall into the medical category and cannot be included in the scope of business of this category. When promoting, medical-related effects cannot be mentioned, otherwise it will be considered an out-of-scope operation.