Ningxia Hui Autonomous Region Food and Drug Administration Publicly Solicits Opinions on Management Rules of Chinese Medicine Formula Granules

On September 7, the Drug Administration of Ningxia Hui Autonomous Region issued a notice on the public solicitation of "Rules for the Management of Traditional Chinese Medicine Formula Granules in Ningxia Hui Autonomous Region (Trial) (Draft for Solicitation of Comments)"

The original text is as follows:

Notice on Public Solicitation of Opinions on "Ningxia Hui Autonomous Region Traditional Chinese Medicine Formula Granule Management Rules (Trial) (Draft for Solicitation of Comments)"

In order to promote the development of the traditional Chinese medicine formula granule industry in our district and meet the needs of clinical use of Chinese medicine, our bureau took the lead in drafting the "Ningxia Hui Autonomous Region TCM formula granule management rules (for trial implementation) (draft for comment)", which is now open for comments

1.

2.

Zhou Huijuan 0951-5665636

Mail box: 452501241@qq.

The deadline for comments is September 15, 2021

Attachment: Ningxia Traditional Chinese Medicine Formula Granule Management Rules (Draft for Solicitation of Comments).

Ningxia Hui Autonomous Region Drug Administration

September 6, 2021

Appendix

Ningxia Hui Autonomous Region Traditional Chinese Medicine Formula Granule Management Rules (for Trial Implementation)

(Draft for comments)

Chapter One General Provisions

Article 1 [Objective] In order to strengthen the management of TCM formula granules in Ningxia, regulate the production, sales and use of TCM formula granules, guide the healthy development of the industry, and better meet the clinical needs of TCM, in accordance with the "Pharmaceutical Administration Law of the People's Republic of China" and the State Food and Drug Administration, The State Administration of Traditional Chinese Medicine, the National Health Commission, and the National Medical Insurance Administration "Announcement on Ending the Pilot Work of Chinese Medicine Formula Granules" and other relevant regulations formulate these rules

Article 2 [Scope of Application] These rules are applicable to activities such as the production, sales and use, supervision and management of Chinese medicine formula granules within the territory of Ningxia Hui Autonomous Region

Article 3 [Supervisory attributes] Traditional Chinese medicine formula granules are granules made from single Chinese medicine decoction pieces that are extracted with water, separated, concentrated, dried, and granulated.

The quality supervision of TCM formula granules is included in the management of TCM decoction pieces

Chapter 2 Establishment of Quality Standards

Article 4 [Basic compliance with quality standards] The TCM formula granules produced and sold in Ningxia shall meet the national drug standards or the Ningxia drug standards for TCM formula granules (hereinafter referred to as Ningxia drug standards).

Article 5 [Basis for Standardization] The Autonomous Region Food and Drug Administration shall follow the "Notice on Issuing the Technical Requirements for Quality Control and Standardization of Chinese Medicine Formula Granules" issued by the State Food and Drug Administration (National Food and Drug Administration Announcement No.

Article 6 [Technical Requirements] Enterprises producing traditional Chinese medicine formula granules shall have the ability to develop Chinese medicine formula granules

Article 7 [Circumstances not to be prepared] Traditional Chinese medicine formula granules shall have the basic properties of decoctions.

Chapter III Filing Management

Article 8 [Implementation of Record Management] The varieties of Chinese medicine formula granules are subject to record management, and approval document number management is not implemented

Article 9 [Basic Requirements] A manufacturer of traditional Chinese medicine formula granules shall be responsible for the authenticity, completeness and traceability of the materials submitted for the record, and bear legal responsibility for the authenticity of the materials submitted
.
The Autonomous Region Food and Drug Administration publicly releases the registered manufacturers and the varieties of traditional Chinese medicine formula granules, and sends a copy to the Autonomous Region Health Commission (Traditional Chinese Medicine Administration) and the Autonomous Region Medical Insurance Bureau
.

The processing and production process data, internal control quality standards and other data contained in the record content of Chinese medicine formula granules will not be disclosed
.

Article 10 [Management of filing changes] The filing information of traditional Chinese medicine formula granules shall not be changed at will
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For the registered TCM formula granules, if the content in the record information form and the product technical requirements for record change, the manufacturer shall submit a description of the change and relevant supporting documents, research materials, etc.
for record changes, and notify the relevant change information in a timely manner Medical institutions
.

Chapter 4 Production Management

Article 11 [Qualification of Production Enterprise] An enterprise 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 standard
.

Article 12 [Production Capacity] An enterprise producing traditional Chinese medicine formula granules shall have a 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
.

The production enterprise shall self-process the decoction pieces of Chinese medicine used in the production of Chinese medicine formula granules
.

Article 13 [Traceability System] A Chinese medicine formula granule manufacturer shall fulfill the relevant obligations of the drug marketing license holder, implement the whole process management of the produced Chinese medicine formula granule, and have the whole process traceability and risk management capabilities, and establish a traceability system.
Realize the source can be found, whereabouts can be traced, and strengthen risk management
.

Article 14 [Production Management] The production process of traditional Chinese medicine formula granules such as processing, water extraction, separation, concentration, drying, and granulation of Chinese medicine shall comply with the relevant requirements of the Goods Manufacturing Practice (GMP).
The production of Chinese herbal medicine pieces with good shoddy, moldy and deteriorating Chinese medicinal materials
.

If the Chinese medicinal materials required for the production of Chinese medicinal formula granules can be artificially planted and bred, the Chinese medicinal materials derived from the Chinese medicinal materials planting and breeding bases that meet the requirements of the quality management standards for the production of Chinese medicinal materials shall be used first
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Promote the use of authentic medicinal materials
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Article 15 [Production Process] Enterprises producing traditional Chinese medicine formula granules shall respectively establish quality standards for Chinese medicinal materials, Chinese medicinal pieces, intermediate products and finished products, so as to achieve quality control throughout the entire process
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To carry out production process research, various process parameters shall be determined, detailed production processes and standard operating procedures for each species shall be formulated, and production shall be organized in accordance with the recorded production process
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Article 16 [Risk Management] Manufacturers of traditional Chinese medicine formula granules shall take the initiative to conduct research on the registered Chinese medicine formula granules and continuously improve their quality
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Ningxia traditional Chinese medicine formula granule production enterprises submit an annual report to the Autonomous Region Food and Drug Administration every year
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The content of the report should at least include: the operation of the enterprise quality management system; the purchase, inspection, and use of Chinese herbal medicines; the processing, inspection and use of Chinese herbal medicines; the inspection and release of Chinese herbal formula granules; change management; deviation management; production and sales content related to product quality complaints and monitoring of adverse reactions such as; case; risk assessment
.

Article 17 [Packaging Labels] Labels directly contacting the packaging of TCM formula granules shall at least indicate the record number, name, TCM preparation standards, TCM formula granules performance standards, specifications, production date, product batch number, shelf life, storage, manufacturing enterprise, generated content address and contact information
.

Encourage manufacturers of traditional Chinese medicine formula granules to use information technology such as traceability codes to mark the above information
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Chapter 5 Sales and Use Management

Article 18 [Sales Range] 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 Sunshine, the Ningxia centralized drug procurement platform, and traded online
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Article 19 [Distribution Management] Production enterprises shall directly distribute Chinese medicine formula granules to medical institutions, or entrust pharmaceutical business enterprises with storage and transportation conditions to distribute them
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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 20 [Medical Insurance Payment] If the varieties of Chinese medicine decoction pieces have been included in the scope of medical insurance payment, the Autonomous Region Medical Insurance Bureau may comprehensively consider factors such as clinical needs, fund payment ability, and price, and after expert review, will include the Chinese medicine formula particles corresponding to the Chinese medicine decoction pieces into the payment Scope, and refer to Type B management
.

Article 21 [Clinical Use] The dispensing equipment of traditional Chinese medicine formula granules should conform to the clinical practice of traditional Chinese medicine, and should effectively prevent errors, contamination and cross-contamination.
Packaging materials directly contacting traditional Chinese medicine granules should 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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Chapter VI Supervision and Administration

Article 22 [Responsibilities of Drug Supervision Departments] The Autonomous Region Food and Drug Administration is responsible for the production and filing of TCM formula granules in the administrative area of ​​Ningxia; strengthen the supervision and inspection of TCM formula granules manufacturers, carry out random inspections, monitoring and evaluation, and carry out random inspections and monitoring evaluations when necessary.
Implement extended inspections on standardized planting and breeding bases of Chinese medicinal materials; organize investigations into violations of laws and regulations
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Each city and county market supervision department is responsible for conducting daily supervision and inspection of medical institutions using traditional Chinese medicine formula granules in their jurisdiction, investigating and punishing violations of laws and regulations discovered, and conducting random inspections and monitoring of traditional Chinese medicine formula granules when necessary
.

Article 23 [Responsibilities of other departments] Health departments and medical security departments at all levels shall supervise and inspect the use and reimbursement of Chinese medicine formula particles in medical institutions in accordance with their duties, and investigate and deal with violations of laws and regulations discovered in accordance with the law
.

Article 24 [Inspection and Punishment of Violations of Laws and Regulations] If the following circumstances are found in the supervision and inspection, the Autonomous Region Drug Administration shall conduct investigation and punishment in accordance with the "Drug Administration Law of the People's Republic of China" and other laws and regulations:

(1) The filing materials are inconsistent with the actual development and production, and the production is not organized according to the filing production process;

(2) Chinese medicinal materials and Chinese medicinal pieces are not fully inspected in accordance with the standard or the inspection is unqualified, and then they are put into production; the traditional Chinese medicine formula granules are not fully inspected in accordance with the standard or the inspection is unqualified, and then released;

(3) Not using the decoction pieces of traditional Chinese medicine processed by this unit to produce formula granules;

(4) The production of Chinese medicine decoction pieces and Chinese medicine formula granules does not meet the requirements of pharmaceutical GMP;

(5) Failure to take risk control measures due to safety issues;

(6) Other violations of laws and regulations
.

If the "Drug Production License" is revoked, cancelled or revoked in accordance with the law, the registered Chinese medicine formula granule varieties will automatically become invalid
.

Article 25 [Complaints and Reports] All units and individuals have the right to report violations of laws and regulations in the development, production, sales and use, and filing of Chinese medicine formula granules
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The relevant departments of Ningxia Hui Autonomous Region shall investigate and deal with it in a timely manner in accordance with relevant regulations
.

Chapter 7 Supplementary Provisions

Article 26 [Medical Toxic Drugs] The management of traditional Chinese medicine formula granules involving toxic drugs for medical use, in addition to the provisions of these Measures, shall also comply with other relevant national regulations
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Article 27 [Implementation Date and Interpretation] These rules shall come into effect on November 1, 2021, and shall be valid until October 31, 2023
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During the trial implementation of these rules, if laws and regulations or the State Drug Administration and other ministries and commissions have other provisions on Chinese medicine formula granules, such provisions shall prevail
.
These rules are explained by the Ningxia Drug Administration, Ningxia Health Commission, and Ningxia Medical Security Bureau on their respective duties
.