Guiding Opinions on the Application of Principles in Paragraph 2 of Article 117 of the Drug Administration Law issued

On February 24, the General Department of the State Food and Drug Administration issued an announcement stating that in order to further standardize the handling of administrative punishment cases for Chinese herbal decoction pieces, unify the benchmark for administrative punishment, carry out the investigation and punishment of Chinese medicine decoction pieces cases in accordance with the law, and protect the legitimate rights and interests of citizens, legal persons and other organizations.
According to the "Administrative Punishment Law of the People's Republic of China", "The Drug Administration Law of the People's Republic of China", "Regulations on the Implementation of the Drug Administration Law of the People's Republic of China" and other relevant laws and regulations, the State Food and Drug Administration organized the formulation of the "Regulations on the "Pharmaceutical Administration Law of the People's Republic of China".
Guiding Opinions on the Application of Principles in Paragraph 2 of Article 117
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Attachments: 1.
"Guiding Opinions on the Principles of Application of Paragraph 2 of Article 117 of the Drug Administration Law of the People's Republic of China" The Drug Administration Law of the People's Republic of China (hereinafter referred to as the "Drug Administration Law") fully considers traditional Chinese medicine The characteristics of the decoction pieces, in the second paragraph of Article 117 (hereinafter referred to as this article), special provisions are made on how to punish the production and sale of traditional Chinese medicine pieces that do not meet the drug standards and do not affect the safety and effectiveness
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In order to further standardize the handling of administrative punishment cases for Chinese herbal decoction pieces, unify the benchmark for administrative punishment, carry out the investigation and punishment of Chinese herbal medicine decoction pieces cases in accordance with the law, and protect the legitimate rights and interests of citizens, legal persons and other organizations, in accordance with the "Administrative Penalty Law of the People's Republic of China" (hereinafter referred to as the "Administrative Penalty Law").
Law), the Drug Administration Law, the Implementation Regulations of the Drug Administration Law of the People's Republic of China (hereinafter referred to as the "Implementation Regulations of the Drug Administration Law") and other relevant laws and regulations, the following guidelines are provided for the application of this clause
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1.
In the process of law enforcement of TCM decoction pieces, the drug supervision and administration department should implement the "four strictest" requirements, strengthen the supervision of production, sales and use, adhere to the principles of "legality, rationality, prudence and justice", and adhere to the safety of drugs Bottom line
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2.
When applying this clause, the penalty measures shall be comprehensively implemented in strict accordance with the relevant provisions of the Administrative Penalty Law and the Implementation Regulations of the Drug Administration Law on the application of lighter, mitigated, and non-administrative penalties, taking into account the specific circumstances of the case, quality risks, etc.
Discretion, reflecting the principle of equal punishment
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3.
Pharmaceutical production and operation enterprises shall strengthen quality management in the process of production and operation, and take effective quality control measures to ensure the quality of Chinese herbal decoction pieces
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4.
The decoction pieces of traditional Chinese medicine to which this article applies are processed from natural sources of plants, animals, and minerals
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This article does not apply to the traditional Chinese medicine formula granules and the relevant toxic Chinese herbal medicine pieces in the "Administrative Measures for Toxic Drugs for Medical Use"
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V.
The premise of the application of this clause is that the source of Chinese herbal medicines used in the production of Chinese herbal medicine pieces (including the base, medicinal parts, processing at the place of origin, etc.
) Item 7 of Paragraph 3 "Other Drugs Not Complying with Drug Standards": (1) The properties such as size, surface color, etc.
do not meet the drug standards; (2) The inspection items such as moisture, ash, and drug dust impurities etc.
do not meet the drug standards
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Among them, when the inspection items do not meet the standards, other indicators that do not meet the standards shall be excluded
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6.
The application of this clause does not change the nature of Chinese herbal decoction pieces not meeting the drug standards
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Production and operation enterprises shall recall non-standard decoction pieces in accordance with relevant regulations, find and analyze the reasons, conduct safety risk assessment on them, and deal with them according to the assessment results
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7.
The drug regulatory department shall conduct an objective and impartial investigation to confirm whether this clause applies, and the parties concerned shall actively cooperate
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If it is difficult to determine whether or not this clause applies, the drug regulatory department shall conduct risk research and judgment based on the specific circumstances of the TCM decoction pieces that do not meet the drug standards and the relevant facts identified, and, if necessary, through mechanisms such as expert demonstration or collective research to conduct risk assessments for "not yet available".
Affect safety and effectiveness", and decide whether to apply this clause
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8.
In the process of law enforcement, drug supervision and administration departments should pay attention to collecting and sorting out relevant typical cases, strengthen case guidance, and ensure the correct implementation of this article and the unification of law enforcement standards. .
2.
In order to implement the "Drug Administration Law of the People's Republic of China" (hereinafter referred to as the "Drug Administration Law") and standardize the determination principle of Paragraph 2 of Article 117 of the "Drug Administration Law", according to the relevant work arrangements, the State The Food and Drug Administration organized the drafting of the "Guiding Opinions on the Principles for the Application of Paragraph 2 of Article 117 of the Drug Administration Law of the People's Republic of China" (hereinafter referred to as the "Guiding Opinions")
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I.
Drafting Background The Drug Administration Law fully takes into account the particularity of Chinese herbal medicines, and makes special provisions on its relevant legal responsibilities
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Paragraph 2 of Article 117 stipulates: "If the production or sale of Chinese herbal decoction pieces does not meet the drug standards and does not affect the safety and effectiveness, it shall be ordered to make corrections within a time limit and given a warning; a fine of not less than 100,000 yuan and 500,000 yuan may be imposed.
A fine of not more than $100
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” At present, some provincial drug supervision and administration departments have successively issued guidelines for the determination of "Chinese herbal decoction pieces do not meet drug standards and do not affect safety and effectiveness" in response to the specific practice of this article, and handle cases where Chinese herbal decoction pieces do not meet drug standards.
played a positive role
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In order to implement the spirit of a series of important instructions and instructions issued by General Secretary Xi Jinping on drug safety, further standardize the handling of administrative punishment cases for Chinese herbal decoction pieces, unify the benchmark for administrative punishment, carry out the investigation and punishment of Chinese herbal medicine decoction pieces cases in accordance with the law, and ensure the legality of citizens, legal persons and other organizations.
Rights and interests, keep the bottom line of drug safety, in accordance with the "Administrative Punishment Law of the People's Republic of China" (hereinafter referred to as the "Administrative Punishment Law"), "Drug Administration Law", "The Implementation Regulations of the Drug Administration Law of the People's Republic of China" and other relevant laws, regulations, rules and norms stipulations, and provide guidance
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2.
In the drafting process, in combination with the "Drug Administration Law", "Administrative Punishment Law" and other regulations, extensive research has been conducted on the judgment guidance issued by the provincial drug supervision and administration departments across the country for "Chinese herbal decoction pieces do not meet the drug standards and do not affect the safety and effectiveness".
Opinions, in June 2021, the State Food and Drug Administration organized the drafting of the "Guiding Opinions (Draft for Comment)", and solicited the opinions of the provincial drug regulatory departments
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After sorting and researching the collected opinions, some opinions are adopted. .
In July 2021, a special survey will be organized to listen to the opinions of some provincial bureaus, industry associations, and Chinese herbal medicine manufacturers
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In August, relevant units were again organized to discuss the "Guiding Opinions (Draft for Comments)", and revised and improved the "Guiding Opinions (Draft for Comments)"
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In October 2021, the State Food and Drug Administration solicited public opinions on the "Guiding Opinions (Draft for Comment)", and after studying the collected opinions, adopted relevant opinions and suggestions
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In November 2021, the State Food and Drug Administration will organize some departments and bureaus and directly affiliated institutions to discuss and finalize the "Guiding Opinions" with relevant legal advisors
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Main Contents The Guiding Opinions mainly include the principles of punishment for applicable clauses, product characterization, scope of decoction pieces, applicable circumstances, burden of proof, determination mechanism, and strengthened case guidance
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IV.
Explanation of Relevant Issues (1) Regarding the Principle of Punishment, the drug supervision and administration department should implement the "four strictest" requirements in the process of law enforcement of Chinese herbal medicines, adhere to the principles of "legality, rationality, prudence and justice", and strengthen production, sales and use.
The supervision of each link, keeping the bottom line of drug safety, and at the same time fully considering the characteristics of traditional Chinese medicine and the particularity of Chinese herbal decoction pieces
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Articles 32 and 33 of the “Administrative Punishment Law” revised in January 2021 clarified the circumstances of lesser, less severe, and no administrative punishment, and Article 117 of the “Drug Administration Law” shall apply.
In the case of Paragraph 2, the penalty measures shall be comprehensively determined in strict accordance with the relevant provisions of the Administrative Punishment Law on the application of lighter, reduced, and no administrative penalties, and in light of the specific circumstances of the case, quality risks, etc.
, to reflect the principle of excessive punishment
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First, it is necessary to consider such situations that still belong to the production and sale of inferior drugs; second, the harmful consequences and severity of illegal acts should be considered; third, whether the perpetrator has subjective intentions, etc.
; The second paragraph of Article 117 of the Drug Administration Law shall reflect the principle of equal punishment, and shall be punished according to the specific circumstances of the case. .
(2) Product characterization of applicable clauses Paragraph 2 of Article 117 of the Drug Administration Law fully considers the complex factors that affect the quality of Chinese herbal decoction pieces, and has certain particularities.
"Not yet affecting the safety and effectiveness" mainly refers to "other drugs that do not meet the drug standards" in item 7 of the third paragraph of Article 98 of the Drug Administration Law, which is still a substandard drug
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The drug standards in this article include the Chinese Pharmacopoeia and other national drug standards, provincial standards for Chinese herbal medicines, and processing specifications for Chinese herbal decoction pieces
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In the process of producing and selling Chinese herbal decoction pieces, if other provisions of Article 98 are involved, this clause shall not apply
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Pharmaceutical production and operation enterprises shall strengthen quality management in the process of production and operation, and take effective quality control measures to ensure the quality of Chinese herbal decoction pieces
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For Chinese herbal decoction pieces that do not meet the drug standards, the production and operation enterprises shall recall them in accordance with relevant regulations, find and analyze the reasons, conduct safety risk assessments for them, and deal with them according to the assessment results
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(3) About the scope of decoction pieces to which the clauses apply In "Chinese Pharmacopoeia", decoction pieces refer to the medicinal materials that can be directly used in the clinical or preparation production of traditional Chinese medicine after processing
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Most of Chinese herbal decoction pieces are derived from naturally grown Chinese herbal medicines, which are greatly affected by their growth environment, and may not meet the size, surface color and other items specified in the drug standards, but do not affect the safety and effectiveness
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Toxic decoction pieces should be strictly managed, and this clause does not apply
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TCM formula granules are industrial products of uniform quality produced in accordance with the prescribed standards and processes, and should comply with the provisions of the drug standards
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Therefore, the Chinese herbal decoction pieces mentioned in the "Guiding Opinions" do not include the relevant toxic Chinese herbal medicine decoction pieces and Chinese herbal formula granules in the "Administrative Measures for Toxic Drugs for Medical Use"
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(4) Situations regarding the application of the clauses The sources of TCM decoction pieces are complex, there are many processing methods, and there are many influencing factors.
The setting of each index in the drug standard can only be as close to the true value as possible, and it is impossible to fully reflect its safety and effectiveness. .
Therefore, there is a possibility that the Chinese herbal decoction pieces do not meet the individual items of the drug standard without affecting the safety and effectiveness
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Among them, the source is an important item to identify the authenticity of Chinese herbal medicine pieces.
Items such as traits, identification, inspection, extracts, characteristic maps, and content determination are the main items that affect the effectiveness of Chinese medicine pieces.
Microbial limit, sulfur dioxide residues, pesticide residues, heavy metals and Harmful elements and mycotoxins are the main items that affect the safety of Chinese herbal decoction pieces
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Considering that China's latitude and latitude spans a lot, and the temperature and humidity between the north and south are significantly different, the moisture and ash content of TCM decoction pieces may not meet the drug standards due to environmental influences, which does not affect their safety and effectiveness.
However, moisture and ash content should be excluded.
Excessive ash content causes other indicators to fail to meet the standard
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Therefore, the premise of applying the second paragraph of Article 117 of the "Drug Administration Law" is that the source of the Chinese herbal medicines used in the production of Chinese herbal medicine pieces (including the base, medicinal parts, processing at the place of origin, etc.
), and the processing technology of the pieces should meet the corresponding requirements.
It is stipulated that enterprises in the production and operation of Chinese herbal decoction pieces should strengthen quality supervision, and try their best to extend the cultivation and processing of Chinese herbal medicines to ensure that they meet the drug standards
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Applicable situations are limited to: the situation that the properties items such as size, surface color and luster do not meet the drug standards; the inspection items such as moisture, ash, drug dust impurities, etc.
do not meet the drug standards, but other indicators that do not meet the standards should be excluded.
safety and efficacy
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(5) Regarding the subject of the burden of proof and the determination mechanism The determination of whether the second paragraph of Article 117 of the Drug Administration Law applies shall be subject to an objective and impartial investigation by the drug regulatory department, and the parties shall actively cooperate
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If it is difficult to determine whether or not the second paragraph of Article 117 of the "Drug Administration Law" applies, the drug supervision and administration department shall conduct risk research and judgment based on the specific circumstances of the non-compliance of Chinese herbal decoction pieces with drug standards and the relevant facts identified, if necessary.
At the same time, through expert demonstration or collective research, it is determined that "the safety and efficacy have not been affected", and it is decided whether to apply the second paragraph of Article 117 of the "Drug Administration Law". .
(VI) Regarding strengthening case guidance and promoting the correct implementation of this clause In the process of law enforcement, drug regulatory authorities should pay attention to collecting and sorting out relevant typical cases, strengthen case guidance, and ensure the correct implementation of this clause and the unification of law enforcement standards
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