What does the business scope of medical herbal therapy preparations include?

The current business scope of domestically compliant medical herbal therapy preparations focuses on the three directions of production, circulation and end-use of herbal medical-related products that have obtained drug regulatory registration/approval qualifications. However, the allowable boundaries of different business entities vary greatly, and there is no unified full category coverage list.

A while ago, I accompanied a friend who opened a community Chinese medicine clinic to expand the business scope. I was quite touched by this. At that time, the staff at the drug supervision window specially drew a few red lines for us: if the production entity obtains the relevant business scope, it can only produce approved herbal medical dressings, Xiaohao herbal antibacterial preparations, and Yaozhun herbal patent medicines. Even if the herbal ointments prepared in private have good clinical effects, they cannot be produced and sold without official approval.

There is actually a lot of debate about the boundaries of this area in the industry. Many practitioners of grassroots traditional Chinese medicine physiotherapy believe that herbal fumigation packs and topical ointments that are homemade in the hospital and used only by patients in the institution should be included in the allowed scope of this business scope as long as regular safety filings are made. There is no need to go through complicated drug approval processes. After all, many of them are prescriptions that have been passed down for generations and have been used by surrounding residents for decades without any problems.； However, many experts on the regulatory side believe that herbal ingredients are complex and it is difficult to standardize the quality differences between batches. If the business authority of homemade preparations is released, it is easy to have illegal publicity and abusive additions, and the risks are difficult to control.

I once met an owner of a health care center. I saw how much money his colleagues made selling herbal moxibustion patches. He went to the industrial and commercial office to add the business scope of medical herbal therapy preparations. Then he turned to a small factory and ordered a batch of herbal moxibustion patches that did not have any approval documents and claimed to be able to cure rheumatoid arthritis. They just sold. After half a month, he was reported by consumers. Not only was he fined hundreds of thousands, but the newly added business scope was also taken back. He had previously thought that as long as this item was on the business license, he could sell any related products. He did not realize that the qualifications of the product itself were the core criterion.

To put it bluntly, this business scope is more like an entry-level "ticket". You don't just get it and you can do related business casually. The specific products you can operate ultimately depend on whether the product in your hand has obtained the drug regulatory approval of the corresponding category. If you are not sure, confirm with the local drug regulatory department in advance to avoid many unnecessary detours.