The requirements for registration of pCms are dependent on the classification category of the pCm under application, and the registration group selected by the applicant.
Based on the composition, usage and sales history, pCms are classified into one of three different classification categories, namely the "Established medicines category", "Non-established medicines category", and "New medicines category". "Health-preserving medicines" and "Other medicines" are the two sub-categories under the "Non-established medicines category". The "Other medicines category" includes "Single Chinese medicine granules" that fall within the definition of pCm.
The registration groups of pCm are Group I, Group II and Group III. Different registration groups have different registration requirements, and hence require different documents.
For pCms under the "Established medicines category" and "Non-established medicines category", applicants may choose to apply for registration in any of the three groups. However, for pCms in the "New medicines category", as their compositions, routes of administration, indications or dose forms are different from traditional use, hence scientific evidence is essential to ensure their safety and efficacy and they must be registered according to Group III registration requirements.