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

The first is in-hospital traditional Chinese medicine/ethnic herbal preparations that have obtained the "Medical Institution Preparation Registration Approval" issued by the drug regulatory department at the provincial level and above. This type of medicine can only be used within the medical institution that issued the approval and cannot be circulated and sold externally.； Second, among the Chinese patent medicines and ethnic medicinal preparations that have received approval from the State Food and Drug Administration, the raw materials are mainly herbal. Common isatis granules, mugwort patches with approval, and herbal bath bags from the Tibetan medicine system are all in this category.

Many people who are new to the industry tend to confuse this boundary. I encountered a real pitfall two years ago when I was helping a community Chinese medicine clinic near my home apply for business qualifications. At that time, the old Chinese medicine doctor in the clinic had a recipe for herbal ointment for bruises and bruises that had been passed down for decades. The effect was particularly good. We thought at first that we could sell it normally under the name of "medical herbal preparations", but it turned out that we went to the city supervision It was only after filing the application that I realized that if this ointment was only to be used symptomatically by patients who came to the hospital for medical treatment, it would have to go through the hospital's preparation approval process to obtain a "pharmaceutical label" batch number. If it wanted to put it on the shelf and sell it to non-medical patients, it would have to undergo a phase III clinical trial and go through the full process approval process in accordance with the requirements of the national drug approval label. I didn't understand it at the time, so I put it on trial for two days and received a rectification notice. I was particularly impressed.

There is a lot of controversy over this classification in the industry. Many private practitioners of traditional herbal therapy feel that the current classification is too vague. Many local herbal prescriptions have been passed down for hundreds of years. If the conventional drug approval process is used, it will cost hundreds or tens of millions, and there is no possibility of implementation. They call for medical herbal therapy preparations to be listed as a separate business scope and to open a green channel for special therapies of intangible cultural heritage.； However, the drug regulatory authorities hold the opposite view to that of many compliant pharmaceutical companies. They feel that once this category is opened separately, it will be easy for people with ulterior motives to exploit the regulatory loopholes. After all, in the past few years, many three-no products under the banner of "medical herbal" just took advantage of the popularity of ambiguous classifications and sold homemade products with Xiaoxing brand, makeup brand, or even no batch number as drugs, which deceived many consumers who did not know what was going on.

If you really want to do related business, you don’t have to worry about classification. Just focus on the approval document of the product. As long as it is classified as a drug, it must be labeled as “National Drug Approval” or “Pharmaceutical Manufacturer”. No matter how impressive it is in the publicity, products with other batch numbers cannot be sold within the scope of the drug category, otherwise it will be easy to step on the red line of compliance.