Regulations for Registration of Medicinal Products Article 86

The review criteria for concentrated Chinese medicine preparations are as follows:1. In principle, compounds shall be decocted in combination. Those whose original formula involves traditional pills or powders may be decocted separately. Donkey-hide gelatin, mirabilite, maltose, and others not suitable for adding into decocting shall not be decocted in combination with others.2. Extracts of decocted medicines may be prepared with lactose or starch, as listed in the Chinese Pharmacopoeia, or with excipients that do not affect efficacy. If the original formulation basis involves traditional pills, non-boiled traditional powders, or other medicines approved by the central health competent authority, the extract may be prepared with Chinese medicine base powders.3. The levels of microorganisms, heavy metals, and pesticide residues in concentrated Chinese medicine preparations shall be within the limits announced by the central health competent authority.4. The ratio of extracts to excipients should be 1:1 in principle, with an upper limit of 1:3.5. The ratio of crude drugs actually produced to extracts shall be up to 15% more or less than the figure specified in the application.The quantitative method, specifications, and required materials for marker ingredients of concentrated Chinese medicine preparations shall be in compliance with the regulations announced by the central health competent authority.