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《Catalogue of China's listed medicines》Ask for advice! 4 categories of products will be included |
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Author:中國銘鉉 企劃部 Release Time:2017-9-5 11:37:37 Number Browse:807 |
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Medical network - on September 5, for the implementation of the general administration of quality of generic drugs and curative effect evaluation of consistency announcement of relevant matters of demands, human medicinal center in accordance with the instruction of the Chinese drug supervision administration organization drafted the directory listed Chinese medicine "(draft).
Given that the catalogue of Chinese listed medicines is still in its infancy stage, the contents and varieties of the catalogue are still very few, which will gradually increase and expand the corresponding content as the new variety is included. On September 4, CDE publicly solicited views and Suggestions on the basic framework structure and information of China's listed pharmaceutical catalogue. The consultation deadline is September 15, 2017.
The catalogue of listed medicines in China consists of preface, guide to use, catalogue of medicines, appendix and index. The use instructions of the catalog set, the contents of the contents and the specific meanings of relevant terms are introduced. The catalogue of drugs lists the active ingredients, drug names, specifications, dosage forms, parameters, manufacturers and other basic information of the drug. The appendix contains information such as patents and data protection; Indexes help users retrieve information. The catalogue set will be dynamically managed, and the newly approved drugs will be included in the catalog, which will be transferred from the catalogue.
The research data on the safety and effectiveness of the complete specifications have been approved for innovative drugs, improved new drugs and imported raw drugs; Generic drugs approved under the new registration of chemical drugs; Drugs that are evaluated with consistency of quality and efficacy; The four categories of drugs identified by the state administration of food and drug administration (fda) will be included in the catalogue of Chinese listed medicines.
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