What is the business scope of medical herbal therapy preparations?

At present, the business scope of domestically compliant medical herbal therapy preparations is limited to "the research and development, production, and sales of herbal preparations that have obtained the corresponding medical device/certification license/national drug approval/in-hospital preparation qualifications, as well as healing supporting services within the scope of the corresponding qualifications." Herbal-related products or services that exceed this boundary and claim to have medical efficacy without corresponding qualifications are all out-of-scope operations.

Don’t think this definition is false. Last year, when I helped a friend open a skin care agency to expand its business scope, I actually stepped through this pitfall. At that time, we wanted to put all of our herbal repair products into the business category related to "medical herbal therapy preparations." However, the staff at the city supervisory window directly called back and said that our herbal cream, which focuses on repair, is a makeup brand. Even if the ingredients are all herbs and the soothing effect is good after actual use, as long as there are no medical-related qualifications of a mechanical brand or a consumer brand, it cannot be classified in this category and can only be regarded as an ordinary cosmetics business.

Regarding the boundaries of this business scope, there are now different voices in the industry. Many practitioners of traditional Chinese medicine for external treatment feel that as long as those homemade herbal ointments and medicated bath packs that have been passed down for generations and have been used clinically for decades without problems, as long as they are used by licensed physicians in regular clinics, there is no need to go through the complicated approval process of brand names and erasures. The filing requirements should be relaxed and included in the scope of legal business. ； However, the regulatory consideration is that once the access to self-made products is liberalized, it will be easy for false propaganda and illegal additions to occur. After all, it is difficult for ordinary consumers to distinguish between "real effective prescriptions" and "thrown-out products", so the qualification requirements are still stuck.

Last year, a traditional Chinese medicine clinic in Hangzhou that had been open for nearly ten years stepped on this red line. The homemade herbal anti-itch ointment in their clinic was very effective and regular customers often came to buy it. The operators put it on the takeout platform to make it convenient for everyone. As a result, they were reported as operating out of scope. They only obtained the qualification for this ointment to be an in-hospital prescription preparation, and it was only for use by patients who came to the clinic. For external sales, they needed to apply for an additional elimination or mechanical brand qualification. In the end, not only were all the products removed from the shelves, but they were also fined 120,000 yuan.

In addition to product management, if you have the corresponding service qualifications, you can customize medical herbal preparations for medical institutions and health care institutions, and supply herbal preparations for healing projects. These are also within the legal scope, provided that your qualifications completely match the qualifications of the products you supply. For example, if you only have the production qualification of a Class I machine brand, you cannot accept processing orders for medical herbal preparations of a Class II machine brand, otherwise it will be considered out of scope.

Some regions are now piloting a regional registration system for temporary herbal preparations. Homemade preparations in hospitals that meet the requirements can be circulated in cooperative medical institutions in the region after registration. This is equivalent to opening a small opening for compliant traditional herbal therapy preparations. The boundaries of the business scope may be adjusted in the future. However, at this stage, operations must strictly adhere to the current qualification requirements and do not step on the red line.