Jilin Province Solicits Opinions on the Implementation Rules for the Management of Traditional Chinese Medicine Formula Granules

Medical Network News on September 2
All relevant units: In order to implement the document requirements of the "Announcement on Ending the Pilot Work of Chinese Medicine Formula Granules" (No.
22 of 2021) by the Fourth Committee and Bureau of the State Food and Drug Administration, based on the actual situation of our province, our bureau drafted The "Implementation Rules for the Management of Chinese Medicine Formula Granules in Jilin Province (Draft for Solicitation of Comments)" (see attachment) is now open for revision
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If you have any suggestions, please give written feedback to the Drug Registration and Administration Office of our bureau before September 15
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Attachment: Implementation Rules for the Management of Traditional Chinese Medicine Formula Granules in Jilin Province (Draft for Solicitation of Comments) Contact person and contact information: Yu Tao 0431-81763121 Du Yujia 0431-81763185 Contact address: Jilin Province Drug Administration, No.
657 Zhanjiang Road, Economic and Technological Development Zone, Changchun City, Jilin Province The Administration Bureau August 30, 2021
Implementation Rules for the Management of TCM Formula Granules in Jilin Province
(Draft for Solicitation of Comments)
Article 1 is to strengthen the management of TCM formula granules in Jilin Province, standardize the production and use of TCM formula granules, guide the healthy development of the industry, and better meet the needs of TCM For clinical needs, these rules are formulated in accordance with the "Pharmaceutical Administration Law of the People's Republic of China", "Announcement on Ending the Pilot Work of TCM Formula Granules", and "Technical Requirements for Quality Control and Standard Establishment of TCM Formula Granules" and other legal and regulatory documents
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Article 2 These rules are based on the relevant requirements of the "Announcement on Ending the Pilot Work of TCM Formula Granules" jointly issued by the State Food and Drug Administration, the State Administration of Traditional Chinese Medicine , the National Health Commission, and the National Medical Insurance Administration.
The pharmaceutical production enterprises and users of the production conditions shall implement management work
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Article 3 These rules apply to activities such as production, distribution, use, supervision and management of Chinese medicine formula granules in Jilin Province
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Article 4 The traditional Chinese medicine formula granules stipulated in these rules refer to the granules made from single Chinese medicine decoction pieces through water extraction, separation, concentration, drying, and granulation.
The patient takes it for use
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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 5 A Chinese medicine manufacturer that produces Chinese medicine formula granules shall obtain a "Drug Production License" and have the scope of production of Chinese medicine decoction pieces and granules at the same time
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Article 6 An enterprise producing traditional Chinese medicine formula granules shall have the complete production capacity of traditional Chinese medicine processing, extraction, separation, concentration, drying, and granulation, and a production scale corresponding to the number of varieties it produces and sells
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The production enterprise shall concoct the decoction pieces of Chinese medicine used in the production of Chinese medicine formula granules by itself
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Article 7 The production enterprise of Chinese medicine formula granule shall fulfill the main responsibility and related obligations of the whole life cycle of the medicine, implement the whole production process management, establish a traceability system, gradually realize the source and destination can be traced, and strengthen risk management
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The production process of traditional Chinese medicine formula granules such as processing, water extraction, separation, concentration, drying, and granulation of traditional Chinese medicine should meet the relevant requirements of the Good Manufacturing Practice (GMP)
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The Chinese medicinal materials required for the production of Chinese medicinal 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 the quality management standards for the production of Chinese medicinal materials
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Promote the use of authentic medicinal materials
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Article 8 The production enterprise of traditional Chinese medicine formula granules shall set up special drug monitoring and evaluation institutions and full-time personnel, establish a drug monitoring and evaluation system, have the ability to implement risk management for Chinese medicine formula granules, and be responsible for establishing and maintaining a drug adverse reaction monitoring system.
Monitoring and evaluation for management
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Article 9 The registration management of Chinese medicine formula granule varieties is implemented, and the approval number management is not implemented
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The manufacturer shall report to the Jilin Provincial Drug Administration for the record before listing .
Article 10 The manufacturer of Chinese medicine formula granules shall submit complete information to the Provincial Drug Administration through the information platform for the record of Chinese medicine formula granules, and shall be responsible for the authenticity of the information.

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The record information platform of Chinese medicine formula granules automatically generates the record number of Chinese medicine formula granules
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Article 11 The standards implemented for the varieties of traditional Chinese medicine formula granules shall comply with the national drug standards.
If the national drug standards are not specified, they shall comply with the standards promulgated by the Jilin Provincial Food and Drug Administration
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TCM formula granules that do not have national drug standards or standards issued by the Jilin Provincial Food and Drug Administration shall not enter Jilin Province for clinical use
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Direct contact with the label of the TCM formula granule packaging should at least indicate the record number, name, TCM decoction piece implementation standard, TCM formula granule implementation standard, specifications, production date, product batch number, shelf life, storage conditions, manufacturer, production address, contact information, etc.
Content
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Article 12 If the Chinese medicine formula granules produced by other province's Chinese medicine formula granule production enterprises enter the medical institutions of Jilin Province for use, they shall be reported to the Provincial Drug Administration for the record, and the production enterprises and their varieties that have not been recorded shall not be sold and used in Jilin Province
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Article 13 The Provincial Food and Drug Administration publishes the list of registered Chinese medicine formula granules by manufacturers and users on the website of Jilin Provincial Food and Drug Administration
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Article 14 Chinese medicine formula granules shall not be sold outside medical institutions
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The traditional Chinese medicine formula granules used by medical institutions shall be purchased through the provincial centralized drug procurement platform Sunshine
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Article 15 Enterprises producing traditional Chinese medicine formula granules directly deliver traditional Chinese medicine formula granules to medical institutions, or they may entrust the distribution of medicine business enterprises with storage and transportation conditions.
Enterprises that accept the distribution of traditional 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 16 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, contamination and cross-contamination.
The materials directly contacting Chinese medicine formula granules shall meet the requirements for medicinal use
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The adjustment software used shall be traceable to the adjustment process
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The specific clinical use methods are implemented in accordance with the relevant regulations of the Provincial Administration of Traditional Chinese Medicine
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Article 17 The drug supervision and management department is responsible for the supervision and management of the province's traditional Chinese medicine formula granule production enterprises and medical institutions using Chinese medicine formula granules, including them in the routine inspection plan, and implementing extended inspections of the enterprise's standardized planting and breeding bases of traditional Chinese medicine when necessary.

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The Provincial Food and Drug Administration included the traditional Chinese medicine formula granules produced and used in the province into the scope of provincial annual supervision and sampling
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Article 18 The registered Chinese medicine formula granules shall be subject to the record modification according to the above procedures and requirements
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After the completion of the change filing, the Chinese medicine formula granules will receive a new filing number
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Article 19 The registered Chinese medicine formula granule production enterprises shall submit their annual reports to the filing department in accordance with the above procedures and requirements
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The content of the annual report should include: resource evaluation, the matching of the source of raw materials and the production and sales, the analysis of the operation and full inspection of the enterprise quality inspection department, the analysis of the operation of the enterprise quality management department, the completion of quality traceability, the status of changes, and the use of hospital lists, circulation traceability, hospital inspection, product quality-related consumer complaints, monitoring of adverse reactions annual summary results and related instructions
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Article XX Chinese medicine formulations particles public record information platform will automatically record basic information, including: Chinese medicine formulations particles name, manufacturer, performance standards, record time, record number, name, etc.
using the hospital
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Article 21 The basic information on the record of Chinese medicine formula granules shall be used for supervision and inspection and extended inspection by the drug supervision and administration department, as well as for the supervision of the society and the public
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Undisclosed filing materials are only used for supervision and inspection and extended inspection by the drug regulatory authority
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Article 22 The Provincial Health Commission and the Provincial Administration of Traditional Chinese Medicine shall instruct medical institutions to use traditional Chinese medicine formula granules according to actual clinical needs.
Principal status, and included in the relevant evaluation indicators of public hospitals of traditional Chinese medicine
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Article 23 The Provincial Medical Security Bureau may comprehensively consider factors such as clinical needs, fund payment capacity, and price, and according to procedures, include the traditional Chinese medicine formula particles corresponding to the medical insurance payment scope into the medical insurance payment scope, and refer to the category B management
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Article 24 The drug supervision and administration department shall strengthen the responsibility of territorial supervision, strengthen the management during and after the incident, strengthen inspection, random inspection and monitoring, implement extended inspections on standardized planting and breeding bases of Chinese medicinal materials, and deal with violations of laws and regulations
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Article 25 The production enterprises and clinical users of traditional Chinese medicine formula granules shall cooperate with the supervision and inspection of the drug supervision and administration department, and shall cooperate with the inspection, and shall not refuse or conceal
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Article 26: If the drug supervision and administration department finds the following situations during the supervision and inspection, it shall investigate and deal with it in accordance with relevant laws and regulations , cancel the record of the Chinese medicine formula granule production enterprises and the types of Chinese medicine formula granules, and report relevant information to the Provincial Health Commission, Provincial Medical Security Bureau and Provincial Traditional Chinese Medicine Administration
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(1) The production process of traditional Chinese medicine formula granules does not meet the requirements of pharmaceutical GMP; (2) Without the record of Jilin Province Drug Administration, the drug manufacturer produces and sells without authorization, and the clinical user uses it without authorization; (3) The content of the record data and The actual production is inconsistent, and the production is not organized according to the recorded production process; (4) There are safety problems and no risk control measures are taken; (5) There are other violations of laws and regulations
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Article 27: If the drug supervision and administration department discovers hidden safety hazards in the production and use of Chinese medicine formula granules during the supervision and inspection, it shall take measures such as warning, interviews, rectification within a time limit, and suspension of production and sales
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Any violations of laws and regulations found in supervision and management and random inspections shall be investigated and dealt with in accordance with the law
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Article 28 The implementation rules will be implemented on November 1, 2021.
The Jilin Provincial Drug Administration, Jilin Provincial Traditional Chinese Medicine Administration, Jilin Provincial Health Commission, and Jilin Provincial Medical Security Bureau shall carry out the work they are responsible for.
Explain
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