Recently, the State Drug Administration ("SDA") has arranged for relevant entities to formulate the Technical Guidelines on the Revision of Provincial Rules for the Preparation of Sliced Pieces of Traditional Chinese Medicine (the "Guidelines").
The Guidelines state that revising provincial rules for the preparation of sliced pieces of traditional Chinese medicine (TCM) requires comprehensive surveys and studies into the varieties of medicinal plants (animals and minerals) that are used as raw materials to process TCM sliced pieces, their properties, places of origin, situations of available resources, quality control, clinical application, and so forth; as to the revision of rules for preparing medicinal sliced pieces with toxicity, consideration shall be also given to the impact brought by preparing techniques on the safety of sliced pieces. In addition, the Guidelines clearly specify that, any products still under scientific studies which have not been widely considered as safe so far and for which data on their efficacy is not available, and such ordinary products as pills and drug granules that are regulated as preparations, shall not be written into provincial rules for the preparation of TCM sliced pieces. According to the Guidelines, efforts to update provincial rules for the preparation of TCM sliced pieces, shall be generally made in an orderly manner through different steps, including the selection of varieties, sample collection, studies into the formulation, technical reviews, public consultation, release and implementation.