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Simplify the registration and approval of classic Chinese medicine compound preparations! The work advancement meeting was held

  Recently, the state administration of traditional Chinese medicine, the state drug administration jointly held the ancient classic famous prescription work advancement meeting, implementing Law of the People's Republic of China on Traditional Chinese Medicine, the Views of the Central Committee of the Communist Party of the State Council on promoting the inheritance and innovation of TCM and the eighth big supervision requirements of the State Council, speeding up the research into the key information of ancient classic famous prescription, and simplifying the registration and approval of traditional Chinese medicine compound preparations. Wang Zhiyong and Huang Luqi, deputy director and party member of the State Administration of Traditional Chinese Medicine, and Zhao Junning, deputy director and Party member of the State Medical Products Administration attended the meeting. Representatives from department of Science and Technology of State Administration of Traditional Chinese Medicine, Department of Drug Registration administration of State Medical Products Administration, Drug Audit Center and China Academy of Chinese Medical Sciences attended the meeting.

  The meeting introduced the recent progress of the work related to ancient classical prescriptions. Since the release of Notice on Public Solicitation of Research materials on key information of Ancient Classic Recipes, we have received key information research materials submitted by enterprises, universities, scientific research institutes and other relevant units, covering all 100 prescriptions in the first batch of catalogues. At present, the formulation process and methodology of international consensus guidelines have been referred to, and the Expert consensus Formation Plan for Key Information of Classic famous prescriptions has been formulated in combination with the actual situation of key information textual research. In the near future, expert consensus evaluation will be given priority to prescriptions with high consensus. At the same time, we are speeding up the establishment of an evaluation model that is compatible with the characteristics of ancient famous prescriptions. We are preparing for the establishment of an expert evaluation committee composed of academicians of Traditional Chinese medicine, masters of Traditional Chinese medicine, and famous Chinese doctors of traditional Chinese medicine across the country to simplify the examination and approval process. In addition, the meeting also introduced the relevant technical review requirements of traditional Chinese medicine compound preparations . In addition to reducing the corresponding application materials scientifically and reasonably, the next step will be to strengthen policy publicity and technical guidance, give full play to the original advantages of TRADITIONAL Chinese medicine, and promote the transformation of clinical effective Chinese medicine with classic prescription.

  Huang luqi pointed out that we should attach great importance to the research of key information of ancient classic prescriptions, standardize consensus evaluation, adhere to the principle of respecting the ancient and not muddling the ancient, give full play to the role of experts in various fields, ensure objectivity, fairness and scientific evaluation, and the consensus results are recognized by the industry, and provide technical support for simplified approval.

  Zhao Junning stressed that the purpose of simplifying and approving the ancient classic compound preparations is to implement the Law of the People's Republic of China on Traditional Chinese Medicine, the Views of the Central Committee of the Communist Party of the State Council on promoting the inheritance and innovationof TCM and the eighth big supervision requirements of the State Council, promote the important content of the review and approval system reform of the traditional Chinese medicine (TCM), fully respect the characteristics of traditional Chinese medicine, listen to the voiced opinion from the industry, and further speed up the construction of key information and expert committees to create better conditions for innovative research and the innovation of TCM.

  Zhi-yong wang asked to know and grasp the development opportunities of ancient Chinese classic prescriptions in the height of inheritance and innovation , improve the top design, coordinate directory, key information, the overplanning for examination and approval of the review and clinical use, excavate the scientific value of the traditional Chinese medicine and improve the quality and effect of TCM products and lead the high- quality development of Chinese medicine industry .


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