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

The scope of in-hospital preparations that hold the "Medical Institution Preparation License", the scope of marketed herbal preparations that have obtained the national drug approval Z/Device No. approval document, and the scope of non-commercial herbal preparations for small-scale self-use by grassroots traditional Chinese medicine institutions.

The most confusing thing for many practitioners who are new to this field is the boundary issue. In the past two years, I met a friend who opened a community physical therapy center. He prepared herbal medicine packs according to family recipes and gave them hot compresses to customers who came for shoulder and neck conditioning. Just because the poster in the store read "Medical grade herbal therapy to treat shoulder circumference" inflammation", he was inspected by market regulators - if his batch of medicine packages only said ordinary hot compresses and health care, it would be classified as daily necessities, no problem, but as long as it contains the expressions "medical" and "curative effect", it would be classified into the supervision of medical herbal preparations. He does not have the corresponding preparation qualifications, so it is naturally non-compliant.

If it is a Chinese patent medicine herbal preparation that has obtained the Z-approval of the National Drug Approval and has complete production and operation qualifications, its business scope can cover public and private hospitals, physical pharmacies, and compliant online medical platforms across the country. Whether it is granules for internal use or patches and lotions for external use, they can be distributed.； If it is medical herbal dressings and herbal antipyretic patches with Category II and III device brands, as long as the operator has the corresponding device product business qualifications, it can also be sold online and offline in compliance with regulations, and even directly connect with C-end consumers.

In fact, the boundaries of this field in the industry are not yet completely unified. For example, the health commissions of some provinces have issued detailed rules. Practicing traditional Chinese medicine practitioners in grassroots traditional Chinese medicine centers and traditional Chinese medicine clinics can cook external herbal ointments and lotions in small batches according to clinical needs. If they are only used by patients who come for medical treatment and are not sold to the outside world, they do not need to go through the strict approval process for in-hospital preparations and are counted within the scope of legal business.； However, some regions have stricter regulatory standards. Herbal preparations that claim to have therapeutic effects, regardless of whether they are used internally, must obtain a preparation approval document to be considered compliant. Manufacturers operating across regions are most likely to fall into this trap.

I have previously come into contact with a start-up team that makes herbal preparations. They originally wanted to focus on herbal ointments for medical wound repair, but the approval was stuck for more than a year and they did not get the approval for the medical brand name. Finally, they obtained the cosmetics qualification and went online. The business scope can only be ordinary skin care products. Any mention of "medical" or "treatment" is considered false advertising. In fact, if you really want to do this, the safest way is to first get the product formula and positioning, and at the same time ask the local market supervision bureau and health commission to find out the boundaries clearly before entering the market. After all, medical products are related to the health of users, and strict supervision is a good thing. Only by following the correct rules can we avoid detours.