Hebei Provincial Food and Drug Administration Publicly Solicits Opinions on the Implementation Rules for the Management of Chinese Medicine Formula Granules

Article 4 The Provincial Drug Administration is responsible for the supervision and management of Hebei Province’s standard formulation, filing management, production and entrusted distribution of traditional Chinese medicine formula granules
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The Provincial Health Commission and the Provincial Administration of Traditional Chinese Medicine are responsible for researching and formulating relevant policies for the clinical use of traditional Chinese medicine formula granules in Hebei Province and conducting supervision and management
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The Provincial Medical Security Bureau is responsible for the bidding and procurement of traditional Chinese medicine formula granules in Hebei Province, and medical insurance payment and other related work, as well as supervision and inspection
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Each city and county market supervision bureau is responsible for the quality supervision and management of the use of traditional Chinese medicine granules in medical institutions within its jurisdiction
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Chapter 2 Production Management

Article 5 A Chinese medicine manufacturer that produces Chinese medicine formula granules shall meet the following conditions:

(1) Established in accordance with the law in China and able to independently assume responsibility (including the ability to assume responsibility for drug quality and safety)
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(2) Obtain the "Drug Production License", and also have the scope of production of Chinese medicine decoction pieces and granules, and comply with the relevant requirements of the "Pharmaceutical Manufacturing Practices" (GMP)
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(3) It has the complete production capacity of processing, extraction, separation, concentration, drying, and granulation of Chinese herbal medicine pieces, and has a production scale corresponding to the number of varieties produced and sold
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(4) It has supporting quality management rules and regulations, a complete drug quality assurance system, and quality management capabilities such as product release and recall
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(5) Establish a special drug monitoring and evaluation agency and full-time personnel, establish a drug monitoring and evaluation system, have the ability to implement risk management on drugs, undertake the obligations of drug adverse drug reaction monitoring, risk benefit evaluation, and risk control in accordance with the law, and be responsible for the establishment and maintenance of drugs Adverse reaction monitoring system manages drug monitoring and evaluation
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(6) The number of varieties developed by the production enterprise should exceed 400
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Article 6 The production enterprise of Chinese medicine formula granules shall fulfill the main responsibility and related obligations of the whole life cycle of the medicine, establish a traceability system, realize the source can be checked, whereabouts can be traced, and strengthen risk management
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Article 7 The manufacturing enterprise shall cooperate with the supervision work of the drug supervision and administration department, and 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 8 Traditional Chinese medicine formula granules shall be produced in accordance with the recorded production process and meet the national drug standards
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If there is no provision in the national drug standards, it shall comply with the standards established by the provincial drug regulatory authority
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Article 9 The base of Chinese medicinal materials, the processing method of the place of origin, and the storage and logistics enterprises shall be fixed
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If the Chinese medicinal materials required for the production of Chinese medicinal formula granules can be artificially planted and bred, the Chinese medicinal materials from the planting and breeding bases of Chinese medicinal materials that meet the requirements of the Chinese medicinal material production quality management regulations in the local area shall be preferentially used
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The traditional Chinese medicine formula granules are fed with Chinese medicine decoction pieces, and the decoction pieces of Chinese medicine used in the production of Chinese medicine formula granules shall be processed by themselves
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Article 10 The production enterprise shall verify the extraction, separation, concentration, and drying processes to clarify the methods, parameters and conditions of the extraction, filtration, or centrifugation, such as solid-liquid separation, concentration, drying, and molding steps
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The manufacturer should determine the reasonable composition of the preparation through research and clarify the type and dosage range of excipients
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The excipients used in the production shall meet the requirements for medicinal use and the requirements of the corresponding production quality management regulations
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The production process regulations and standard operating procedures for controlling product quality shall be formulated according to the recorded production process, and complete batch production and inspection records shall be established
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Article 11 The label of direct contact with the packaging of traditional Chinese medicine formula granules shall at least indicate the record number, name, execution standards of traditional Chinese medicine preparations, execution standards of traditional Chinese medicine formula granules, specifications, production date, product batch number, shelf life, storage, manufacturer, production address, and contact.
Ways and other content
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Materials that directly contact the granules of traditional Chinese medicine formulations should meet the requirements for medicinal use
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Article 12 A manufacturing enterprise may set up a pre-processing or extraction workshop in a different place, or share a pre-processing and extraction workshop with a pharmaceutical manufacturer within the group that has a controlling relationship.
The details are in accordance with the original State Food and Drug Administration’s proposal on strengthening the extraction and extraction of traditional Chinese medicine production.
The relevant regulations on the supervision and management of extracts shall be implemented
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Article 13 Production enterprises shall have management measures to properly dispose of production waste residues, and strictly prevent the decoction pieces of traditional Chinese medicine extracted by water from entering the market again
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Chapter III Use Management

Article 14 Chinese medicine formula granules shall not be sold outside medical institutions
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Medical institutions shall not purchase undocumented Chinese medicine formula granules
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The Chinese medicine formula granules used should be purchased through the provincial centralized drug procurement platform Sunshine procurement and online transactions
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Directly distributed by the manufacturer, or by the manufacturer's entrusted configuration with a warehouse management system (WMS), and distribution by a pharmaceutical business enterprise that has storage and transportation conditions
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Enterprises that accept the distribution of Chinese medicine formula granules shall not entrust the distribution
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The medical institution shall sign a quality assurance agreement with the manufacturing enterprise
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Article 15 Medical institutions shall check and accept the purchased Chinese medicine formula granules in accordance with the standards, and those that fail to pass the check and acceptance shall not be used
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The manufacturer should provide the medical institution with a self-inspection report of the traditional Chinese medicine formula granules
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Article 16 The training of medical personnel in the rational use of Chinese medicine formula granules shall be strengthened to avoid unreasonable use of Chinese medicine formula granules
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Medical institutions should take effective measures in the monitoring of adverse reactions and safety risk control of TCM granules to ensure the safety of clinical use of TCM granules
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Article 17 The dispensing equipment of traditional Chinese medicine formula granules should conform to the clinical practice of traditional Chinese medicine, and 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 18 Adhere to the dominant position of Chinese herbal medicine pieces
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If the types of Chinese herbal medicines have been included in the scope of medical insurance payment, the provincial medical insurance department can comprehensively consider factors such as clinical needs, fund payment ability and price, and after expert review, the Chinese herbal medicine formula particles corresponding to the Chinese herbal medicines shall be included in the payment scope, and refer to the category B management
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Chapter IV Drug Standards

Article 19 The quality standards of traditional Chinese medicine formula granules are divided into national standards and Hebei province standards
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Hebei Provincial Drug Administration in accordance with the "Technical Requirements for Quality Control and Standard Establishment of Traditional Chinese Medicine Granules in Hebei Province" (for trial implementation) and "Working Procedures for Supplementing the Quality Standards for Traditional Chinese Medicine Formula Granules in Hebei Province and Requirements for Application Documents" (for trial implementation) The formulation and revision of standards
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After the national drug standards for Chinese medicine formula granules are promulgated and implemented, the corresponding standards formulated by the provincial drug supervision and management departments shall be abolished
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If Chinese medicine formula granules without national drug standards are used in Hebei Province, they shall meet the quality standards of Hebei Province Chinese medicine formula granules
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Research institutions and manufacturers that carry out scientific research on the standards of traditional Chinese medicine formula granules can provide research data and quality standards to the Hebei Provincial Drug Administration as required
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Article 20 The formulation of the quality standard of traditional Chinese medicine formula granules should be compared with standard decoctions, fully considering the consistency with the basic properties of traditional Chinese medicine decoction pieces and the particularity of the lack of traits, and fully considering the source of medicinal materials, the preparation of decoction pieces, and the specificity of traditional Chinese medicine formula granules.
Factors that affect quality in various links such as production and use, strengthen specific identification and multi-component, overall quality control, and fully reflect the advanced level of drug quality control at this stage
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The format and terminology of the quality standard of Chinese medicine formula granules should refer to the "Pharmaceuticals of the People's Republic of China", and its contents mainly include: name, source, preparation method, properties, identification, characteristic map or fingerprint map, inspection, extract, content determination, specification ( particles per gram of the formulation of an amount equivalent to Pieces), storage and the like
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The description of the preparation process should include the entire process, the main process parameters, the range of the paste rate, the auxiliary materials and their dosages, and the production volume
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The limits or content of pesticide residues, heavy metals and harmful elements, mycotoxins and endogenous toxic and harmful ingredients should be studied
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Chapter V Filing and Supervision and Administration

Article 21 The registration management of Chinese medicine formula granules shall be carried out, and the production enterprises in Hebei Province shall register before the listing
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Production enterprises that have obtained production licenses in Hebei Province and those that sell cross-border in Hebei Province shall log in to the "Registration Management Module of Traditional Chinese Medicine Formula Granules of the Pharmaceutical Business Application System of the State Drug Administration" in accordance with the requirements of the State Drug Administration (hereinafter referred to as (Referred to as the filing platform of Chinese medicine formula granules) for filing
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The manufacturer shall be responsible for the authenticity, completeness and traceability of the materials submitted for record, and shall bear corresponding legal responsibilities
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Where there are changes to the registered TCM formula granules, the content in the record information sheet and the product technical requirements for the record, the record manufacturer shall make record changes to the original record department in accordance with the procedures and requirements stipulated by the State Drug Administration
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Production enterprises that have been put on record shall submit annual reports in accordance with the requirements
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If the record is not carried out in accordance with the requirements, the Provincial Drug Administration shall deal with it in accordance with the law
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Article 22 The drug supervision and administration department shall strengthen the supervision during and after the event, strengthen inspection, random inspection and monitoring, and may carry out extended inspections on the sources of Chinese medicinal materials and inter-provincial (regional, municipal) workshops or shared workshops in different places.
Production and medical institutions use traditional Chinese medicine formula granules to conduct supervision and random inspections, and make the inspection and inspection results public to the public
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Article 23 Channels for reporting and complaints should be unblocked
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Any unit or individual has the right to report violations of laws and regulations discovered in the development, production, filing, sales, use, and medical insurance payment of Chinese medicine formula granules to relevant functional departments, and relevant functional departments shall verify and deal with them in a timely manner
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Article 24 If there are other regulations in the state for the administration of granules of traditional Chinese medicine prescriptions, those regulations shall prevail
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Each department may formulate relevant supplementary requirements in accordance with their responsibilities and relevant laws, regulations, and regulatory documents
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