CDE releases 3 technical guidelines for the Chinese medicine industry

On June 28, CDE issued three technical guidelines to shake the industry of traditional Chinese medicine, and established the basis of quality control indicators and detection methods for traditional Chinese medicine, Chinese herbal pieces and Chinese herbal preparations In order to deepen the reform of drug review and approval system, further encourage innovative research and development of traditional Chinese medicine, and accelerate the establishment of technical evaluation standard system in line with the characteristics of traditional Chinese medicine, the drug review center has started the preparation and revision of 12 technical guidelines for pharmaceutical research of traditional Chinese Medicine since 2018 At the same time, in order to cooperate with the implementation of the work plan for the centralized treatment of the quality of Chinese herbal pieces (GYJ [2018] No 28) issued by the State Drug Administration, and guide and standardize the quality management of Chinese herbal medicine, pieces of Chinese herbal medicine and preparations, the drug Evaluation Center organized experts to write the technical guidelines for the control of the quality and quantity of Chinese herbal materials (Draft for comments), and the research on the quality standards of new Chinese herbal medicines Technical guidelines (Draft for comments) and technical guidelines for pretreatment of raw materials of traditional Chinese medicine (Draft for comments) (see Annex 1-3 for details) We are now on the Internet to solicit public opinions and welcome valuable opinions and suggestions from all walks of life Your feedback can be sent to our center by email Deadline for consultation: September 30, 2019 Contact person: Chen Hao email: zyyxzdyz@cde.org.cn (pinyin acronym for guiding principles of traditional Chinese medicine and pharmacy) thank you for your participation and support! Technical guidelines for research on quality control of traditional Chinese medicine (Draft for comments) issued by drug evaluation center of State Drug Administration on June 28, 2019.pdf technical guidelines for research on new drug quality standards of traditional Chinese medicine (Draft for comments) PDF technical guidelines for pretreatment of raw materials of traditional Chinese medicine (Draft for comments)