echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Active Ingredient News > Drugs Articles > [comments] four conditions should be met for the enterprises to release the dispensing granules of traditional Chinese medicine

    [comments] four conditions should be met for the enterprises to release the dispensing granules of traditional Chinese medicine

    • Last Update: 2015-12-31
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    Source: CFDA official website on December 30, 2015, CFDA official website released the measures for the management of traditional Chinese medicine formula granules (Draft for comments), which formally solicited opinions from the public The deadline for comments was March 1, 2016 In the past, only six enterprises were allowed to pilot production, and the access conditions were specified in the draft for comments What information should be paid special attention to in this document? 1 The four access conditions are as follows: the production enterprises of traditional Chinese medicine formula granules should meet the following conditions: (1) be established in accordance with the law in China, and be able to bear responsibilities independently( Including the ability to bear the responsibility for the quality and safety of drugs; (2) the company has obtained the production scope of granules and has the complete production capacity of processing, extracting, concentrating, drying and granulating of Chinese herbal pieces, which conforms to the requirements of the GMP; (3) Establish special organization and full-time personnel for drug quality inspection and management, formulate quality management rules and regulations, have perfect drug quality assurance system, and have the quality management ability of product release and recall; (4) Establish a special agency and full-time personnel for drug monitoring and evaluation, establish a drug monitoring and evaluation system, have the ability to implement risk management for drugs, undertake the obligations of adverse drug reaction monitoring, risk benefit assessment and risk control according to law, establish and maintain a drug adverse reaction monitoring system, and manage drug monitoring and evaluation 2 The manufacturer shall evaluate the resources of the Chinese herbal medicines used and implement full traceability The origin of traditional Chinese medicine should be fixed, and specific production locations, planting / breeding enterprises or farmers, collectors, purchasers, primary processors, warehousing and logistics enterprises should be implemented To advocate the use of genuine medicinal materials, we should determine the output of Chinese medicine formula granules according to the quality of Chinese medicinal materials and the output per unit area of plants or the quantity of animal breeding 3 The enterprise may provide research data and drug standards independently or jointly, and the national pharmacopoeia committee shall organize the formulation and revision of unified drug standards for traditional Chinese medicine formula granules The research institutions and manufacturers that carry out the scientific research on the standards of traditional Chinese medicine formula granules can provide research data and drug standards to the national pharmacopoeia committee independently or jointly as required For the same variety produced by multiple enterprises, the formulation and revision of drug standards should be unified on the basis of science and rationality, and the principle of "high not low" should be adhered to A batch of mature ones will be released In the spirit of encouraging enterprises to participate in the drafting of the standard and defining the responsible body, the name of the drafting unit shall be indicated in the approved standard of traditional Chinese medicine formula granules 4 Comparison with standard decoction The formulation of the standard for granule drugs of traditional Chinese medicine should be compared with the standard decoction The consistency with the basic attributes of Chinese herbal pieces and the particularity of the lack of properties should be fully considered The factors affecting the quality of each link, such as the source of medicinal materials, the preparation of Decoction pieces, the production and use of granules of traditional Chinese medicine formula, should be fully considered The identification of special properties and the control of multi-component and overall quality should be strengthened to fully reflect the present situation The advanced level and quality of stage drug quality control come from the concept of design 5 The inspection standard of internal control finished products shall be higher than the unified standard The manufacturer shall formulate strict internal control drug standards, and define the quality control measures, key quality control points and relevant quality requirements in the whole production process The internal control drug standards include raw materials, materials for each unit process link, inspection standards for finished products of traditional Chinese medicine formula granules and process control indicators Among them, the inspection standard of internal control finished products should be higher than the unified standard 6 The information shall not be changed at will for filing with the provincial department All production enterprises that have obtained the production license shall submit the filing information of the traditional Chinese medicine formula granules to the local provincial food and drug administration according to the requirements of the detailed rules for the implementation of the filing management of traditional Chinese medicine formula granules The filing information of traditional Chinese medicine formula granules shall not be changed at will In case of any change in the contents and technical requirements of the filed traditional Chinese medicine formula granules, the filing enterprise shall submit the description of the change, relevant supporting documents and research data, make the filing change to the original filing department in accordance with the procedures and requirements specified in the detailed rules for the implementation of the filing management of traditional Chinese medicine formula granules, and timely inform the change information Hospitals that use its traditional Chinese medicine formula granules  
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.