Shanxi Province Chinese Medicine Formula Granule Management Implementation Rules (Draft for Solicitation of Comments) Released

On October 11, the Shanxi Provincial Food and Drug Administration issued the "Implementation Rules for the Management of Traditional Chinese Medicine Granules in Shanxi Province (Draft for Solicitation of Comments)", which is now open for revision
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The original text is as follows: Notice of the Office of the Shanxi Provincial Drug Administration on Publicly Soliciting Opinions on the "Implementation Rules for the Management of Traditional Chinese Medicine Formula Granules in Shanxi Province (Draft for Solicitation of Comments)" [2021] No.
108 All relevant units: To implement the National Traditional Chinese Medicine of the State Drug Administration According to the requirements of the “Announcement on Ending the Pilot Work of Chinese Medicine Formula Granules” (No.
22 of 2021) by the National Health Commission and the National Medical Insurance Administration of the State Administration of )” (see attachment), now open for comments on revisions
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If you have any suggestions, please report to the Drug Registry of our bureau in writing before October 15, 2021
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Contact number: 0351-8383542, E-mail: shengjuzcc@163.
com Contact address: No.
85, Longcheng Street, Xiaodian District, Taiyuan City, Shanxi Province, Zip Code: 030031 Contact: Yang Yinzhi Attachment: "Implementation Rules for the Management of Traditional Chinese Medicine Formula Granules in Shanxi Province ( Consultation Draft)" Shanxi Provincial Drug Administration Office October 8, 2021 (voluntary disclosure) Attachment: Shanxi Province Traditional Chinese Medicine Formula Granule Management Implementation Rules (Consultation Draft) The first article is to implement the "Pharmaceutical Administration Law of the People's Republic of China" "The Law of the People’s Republic of China on Traditional Chinese Medicine", to strengthen the management of Chinese medicine formula granules, according to the “Announcement of the State Drug Administration, the State Administration of Chinese Medicine No.
) and other relevant regulations, combined with the actual situation of our province, formulate the implementation rules
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Article 2 These rules apply to the filing, production, sales, distribution, use, medical insurance payment and supervision and management activities of traditional Chinese medicine formula granules in Shanxi Province
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Article 3 Traditional Chinese medicine formula granules are granules made from single-flavored Chinese medicine pieces through water extraction, separation, concentration, drying, and granulation.
Under the guidance of Chinese medicine theory, they are formulated in accordance with clinical prescriptions of Chinese medicine and then used by patients
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The quality supervision of TCM formula granules is included in the management of TCM decoction pieces
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Article 4 The record management of the varieties of Chinese medicine formula granules shall be carried out
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To produce varieties of traditional Chinese medicine formula granules, the manufacturer of traditional Chinese medicine formula granules (hereinafter referred to as the manufacturer) shall report to the Provincial Drug Administration for production record before the market
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The traditional Chinese medicine formula granules used for sale must be reported to the Provincial Drug Administration for sales record by the manufacturer before entering the medical institution for use according to the requirements
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Manufacturers that carry out production filing or sales filing shall submit relevant filing materials through the "Chinese Medicine Formula Granule Recording Management Module of the Pharmaceutical Business Application System of the State Drug Administration" (hereinafter referred to as the formula granule filing module) in accordance with the procedures and requirements
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Provincial Drug Supervision The Administration Bureau is responsible for receiving the filing materials of formula particles (with the official seal of the company), and undertaking the filing work of formula particles
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Article 5 The production enterprise shall be responsible for the authenticity, completeness and traceability of the materials submitted for the record, and ensure that the formula particles are passed The filing materials submitted by the filing module are consistent with the paper materials, and they are legally responsible for the authenticity of the submitted materials
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The manufacturer shall assist the drug regulatory authority to carry out on-site inspections, sample sampling, review inspections and supervision management related to filing
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Article 6 The production enterprise shall actively conduct research on the registered Chinese medicine formula granules, continuously improve the product quality, and submit an annual report to the filing department
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Article 7 The registered Chinese medicine formula granules shall not change the production process without justified reasons ( (Including auxiliary materials), quality standards, packaging materials, production sites, and other information that affect the quality of formula particles
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If it is really necessary to change, the manufacturer should conduct research with reference to the "Technical Guidelines for the Study of Pharmaceutical Changes in Listed Traditional Chinese Medicines (Trial)", etc.
, and submit to the Provincial Drug Administration through the formulation granule filing module in accordance with the relevant filing requirements and procedures after completing the relevant research.
Change relevant research data and make record changes
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The manufacturer should promptly inform the medical institution that uses the Chinese medicine formula granules of the change information
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Article 8 The manufacturing enterprise may communicate with the Provincial Drug Administration on matters related to the record or change record before the record or record change
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Article 9 The Provincial Drug Administration is responsible for formulating and issuing standards for traditional Chinese medicine prescription granules in Shanxi Province in accordance with the "Technical Requirements for Quality Control and Standard Formulation of Traditional Chinese Medicine Formula Granules"
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After the national drug standards for Chinese medicine formula granules are promulgated and implemented, the Shanxi Province Chinese medicine formula granules standards of the corresponding varieties formulated by the Provincial Drug Administration will be abolished
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Article 10 The Chinese medicine formula granules produced in Shanxi Province shall meet the national drug standards; if there is no stipulation in the national drug standards, they shall conform to the Chinese medicine formula granule standards formulated and promulgated by the provincial drug supervision and administration department
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The Chinese medicine formula granules sold and used in Shanxi Province shall meet the national drug standards; if there is no stipulation in the national drug standards, they shall conform to the Shanxi Province Chinese medicine formula granules standards
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Article 11 The excipients used for the production of Chinese medicine formula granules shall meet the requirements for medicinal use; the packaging materials or containers that directly contact the Chinese medicine formula granules shall meet the requirements for medicinal use
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Article 12 Manufacturers producing traditional Chinese medicine formula granules shall obtain the "Drug Production License", and have the scope of production of Chinese medicine decoction pieces and granules, and comply with the requirements of the "Pharmaceutical Production Quality Management Regulations"
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The production enterprise shall self-process the decoction pieces of Chinese medicine used in the production of Chinese medicine formula granules
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Article 13 The manufacturing enterprise shall fulfill the main responsibility and related obligations of the whole life cycle of the drug as stipulated in the "Drug Administration Law", implement management of the whole production process, establish a traceability system, gradually realize the traceability of sources and destinations, and strengthen risk management , Fulfill the responsibilities of drug release on the market, establish a drug quality assurance system, and strictly implement the "Pharmaceutical Production Quality Management Regulations" to ensure that the production process of traditional Chinese medicine formula granules continues to meet legal requirements
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Article 14 The manufacturing enterprise shall cooperate with the supervision work of the drug supervision and administration department, cooperate with the inspection organized and implemented by the drug supervision and administration department, and shall not refuse, evade or hinder
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Article 15 Traditional Chinese medicine formula granules shall be produced in accordance with the recorded production process and conform to the national drug standards
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If there is no provision in the national drug standard, it shall comply with the provincial drug standard of the place of use
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Article 16 Chinese medicinal materials required for the production of Chinese medicinal formula granules that can be artificially planted and bred shall be given priority to use Chinese medicinal materials derived from Chinese medicinal materials planting and breeding bases that meet the requirements of Chinese medicinal material production quality management standards
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Promote the use of authentic medicinal materials
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Article 17 The production enterprise shall determine the reasonable composition of the preparation through research, clarify the type and dosage range of excipients, and clarify the methods and conditions of the steps of mixing, drying, and molding
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Process regulations and production operation regulations shall be formulated in accordance with the recorded production process, and production and inspection records shall be complete and accurate, and shall not be fabricated or tampered with
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Enterprises should combine the actual quality of Chinese medicinal materials and process control levels to formulate internal control standards and key control indicators, and have corresponding production process quality control methods
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Article 18 The name of Chinese medicine formula granules shall be named in the form of "Chinese medicine decoction pieces + formula granules"
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Labels for direct contact with the packaging of TCM formula granules should be marked with the record number, name, execution standards of TCM decoction pieces, execution standards of TCM formula granules, specifications, production date, product batch number, shelf life, storage, manufacturer, production address, contact information, etc.

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Article 19 Production enterprises shall have management measures to properly dispose of production waste residues.
Waste residues must undergo treatment measures such as destruction and destruction, and it is strictly forbidden to re-enter the market after water extraction of medicine residues
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Article 20 Chinese medicine formula granules shall not be sold outside medical institutions
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The Chinese medicine formula granules of public medical institutions should be purchased through the provincial centralized drug procurement platform Sunshine, and online transactions, and offline transactions are not allowed
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Medical institutions shall not purchase Chinese medicine formula granules that have not been filed by the Provincial Drug Administration
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The varieties of traditional Chinese medicine formula granules that do not have the national drug standards or the standards issued by the Provincial Drug Administration shall not enter Shanxi Province for clinical use
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Article 21 The traditional Chinese medicine formula granules used by medical institutions shall be distributed directly by the production enterprise, or be distributed by the pharmaceutical business enterprise that has storage and transportation conditions entrusted by the production enterprise
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The distribution process refers to the implementation of the relevant provisions of the "Measures for the Supervision and Administration of Drug Circulation"
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Enterprises that accept the distribution of Chinese medicine formula granules shall not entrust other enterprises to distribute them
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The medical institution shall sign a quality assurance agreement with the manufacturing enterprise
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Article 22 If the types of Chinese herbal medicines have been included in the scope of medical insurance payment, the Provincial Medical Insurance Bureau may comprehensively consider factors such as clinical needs, fund payment ability, and price, and after expert review, include the Chinese medicine formula particles corresponding to Chinese herbal medicines into the payment scope, and Refer to Type B management
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Article 23 The preparation equipment of traditional Chinese medicine formula granules used by medical institutions shall conform to the clinical practice of traditional Chinese medicine, and shall effectively prevent errors, pollution and cross-contamination
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The adjustment software used shall be traceable to the adjustment process
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Article 24 The Provincial Drug Administration, the Provincial Health Commission, the Provincial Medical Insurance Bureau and other departments shall divide the work and cooperate with each other, strengthen communication and coordination, and jointly do a good job in the management of traditional Chinese medicine formula particles
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When necessary, joint supervision and inspection of traditional Chinese medicine formula granules can be carried out
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Article 25 The drug supervision and administration department shall supervise and inspect the filing, production, distribution, sales and use of traditional Chinese medicine formula granules, and may carry out extended inspections on the standardized planting and breeding bases of traditional Chinese medicine materials, and timely disclose the supervision and inspection results to the society; Carry out supervision and sampling inspections with traditional Chinese medicine formula particles used by medical institutions, and disclose the results of the sampling inspections to the public
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Article 26 The medical insurance department shall strengthen the supervision and inspection of the payment of medical insurance for traditional Chinese medicine prescription granules in our province, and deal with violations in accordance with laws and regulations
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Article 27 The health department shall strengthen the supervision of the prescription and the reasonable use of Chinese medicine formula granules in medical institutions, and investigate and deal with the illegal activities of medical institutions in accordance with the law
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Article 28 In any of the following circumstances, the Provincial Drug Administration shall cancel the production or sales record of the corresponding enterprise's traditional Chinese medicine formula granules: (1) The record materials are not true; (2) The record materials are inconsistent with the actual production situation (3) Failing to record the change of information or perform the annual report as required; (4) The production license of the production enterprise is revoked or cancelled according to law; (5) The filing person applies for cancellation of the filing; (6) The filing should be cancelled according to law Other Circumstances Article 29 The management of traditional Chinese medicine formula granules involving toxic drugs for medical use shall, in addition to being handled in accordance with the provisions of these Measures, also comply with other relevant national regulations
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Article 30 If the state has other regulations on the management of traditional Chinese medicine formula granules, it shall be implemented in accordance with the relevant regulations of the state
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These rules are interpreted by the Provincial Drug Administration, the Provincial Health Commission, and the Provincial Medical Insurance Bureau according to the division of responsibilities
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Article 31 [Implementation Date] These rules shall come into force on November 1, 2021
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