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

There is no separate category of "medical herbal therapy preparations" in the current domestic commercial registration and drug supervision categories. The corresponding commercial drugs are actually included in the supervision of traditional Chinese medicines. They mainly include herbal-related proprietary Chinese medicines that have been approved by the National Drug Approval No.

I have opened a community herbal conditioning shop for almost four years. The products I usually sell for physiotherapy are basically within this range. For example, the Angelica Safflower Dieda Tincture that I often recommend to users who suffer from shoulder and neck sprains is certified Z by the Chinese National Drug Administration, and is considered a proprietary Chinese medicine.； The refined pieces of astragalus and American ginseng used to powder customers with qi deficiency are qualified as traditional Chinese medicine pieces. These two categories are truly within the scope of pharmaceutical business.

However, there are many scammers in the actual business. Many people are confused about what can and cannot be allowed. Two months ago, I accompanied my friend who runs a health center next door to go to the Market Supervision Bureau to change the business scope. He had previously entered his homemade herbal cough pear ointment into the category of medical herbal preparations, but it was immediately rejected. The staff said that this kind of ordinary food without the approval of national medicines must not be included in the scope of business of pharmaceuticals.

In fact, there are many opinions on this matter in the industry. The regulatory standards have always been very strict. As long as herbal related products have not obtained the national drug approval, no matter whether the raw materials are of the same origin as medicine or food, they cannot be considered medical drugs. If you dare to sell ordinary food in the name of medical herbs, you will be fined and confiscated, and your qualifications will be revoked.； However, many practitioners of traditional Chinese medicine clinics who have been working for more than ten years also have different opinions. They say that many herbal ointments and tea substitutes made according to classic recipes do have clear conditioning effects. If they are all included in ordinary food, it will be inconvenient to provide adaptation guidance to customers, and it will also be easy for unscrupulous merchants to take advantage of loopholes for random promotion.

To be honest, the current "medical herbal therapy preparations" are like a big basket with no clear boundaries, and all kinds of products can be put into it, but the regulatory screen is very strict. Only those that have passed the drug approval standards can be counted in the scope of pharmaceutical business, and the others can only go their own way. If you plan to start this business, the safest way is to first obtain the pharmaceutical business license (including Chinese herbal medicine pieces and Chinese patent medicines), the second-class medical device business registration certificate, and the food business license. Report them into different categories according to the approval number of the product. Don't save time by putting everything in the "medical herbal" basket, otherwise problems will easily arise during the annual review or random inspection.