"National Drug Sampling Inspection Annual Report (2020)" released

Medical Network, March 24 News On March 23, the website of China Food and Drug Control Institute released the "National Drug Sampling Inspection Annual Report (2020)" (hereinafter referred to as the "Annual Report").

 

According to the "Annual Report", a total of 136 varieties of preparation products and traditional Chinese medicine decoction pieces will be selected for national drug sampling in 2020, including 77 chemical drugs, 48 ​​Chinese patent medicines, 8 traditional Chinese medicine decoction pieces and 3 biological products, of which 45 are national essential medicines; A total of 18013 batches of samples were sampled, including 4106 batches in the production process, 13143 batches in the business process, and 764 batches in the use process, involving 1053 drug manufacturing companies , 2186 drug trading companies and 347 drug users.

 

Sampling results of various drugs

 

The results of sampling of pharmaceutical preparations showed that a total of 16645 batches of preparation products were sampled, 16568 batches of products were in compliance with regulations, and 77 batches of products were not in compliance with regulations.
Among them, auramine O was detected in 2 batches of samples in accordance with the supplementary inspection method.
Among the 128 varieties sampled, there were 106 preparations with all samples in compliance with the regulations, a total of 13,179 batches.
Among them, there are 8046 batches of 64 varieties of chemical drugs, 5043 batches of 39 varieties of Chinese patent medicines, and 90 batches of 3 varieties of biological products.

 

The results of sampling of proprietary Chinese medicines showed that a total of 6338 batches of 48 varieties were sampled, involving 12 formulations, and 1072, 5197, and 69 batches of samples were taken during production, operation and use.
After inspection, 6304 batches were in compliance with the regulations, 34 batches were not in compliance with the regulations (including 2 batches of products that were not in compliance with the regulations by the supplementary inspection method), and 1 and 33 batches of non-compliant products were detected in the production and operation links respectively.
It accounts for 0.
1% and 0.
6% of all samples in the corresponding link.

 

　　The results of the sampling of biological products showed that there were 90 batches of 3 varieties, including 1 for the treatment type and 2 for the prevention type.
The samples are all drawn from the production process, and the dosage forms are all injections.
After inspection, all inspected items are in compliance with the regulations, and the pass rate is 100%.

 

　　The results of the national essential medicine sampling show that a total of 6167 batches of 37 varieties were sampled, and 1260, 4625 and 282 batches of samples were sampled in the production, operation and use links.
After inspection, 25 batches of non-compliant products were found, and 8 and 17 batches of non-compliant products were detected in the production and operation links, involving 4 dosage forms.

 

　　The results of special sampling of antiviral Chinese patent medicines showed that a total of 932 batches of antiviral Chinese patent medicines were sampled, involving 5 dosage forms.
After inspection, 930 batches were in compliance with the regulations, with a pass rate of 99.
8%.

 

　　The results of special sampling of Chinese herbal medicines showed that a total of 1,368 batches of 8 Chinese herbal medicines were sampled.
After inspection, 1341 batches were in compliance with regulations and 27 batches were not in compliance with regulations.

 

　　Exploratory research found five major problems

 

　　The main problems found in the exploratory study of national drug sampling in 2020 are:

 

　　The first is production in violation of laws and regulations, individual enterprises have low limits, excessive amounts or use substitutes to feed materials, violation of key manufacturing laws, lack of quality assurance systems, and problems such as production line pollution still exist;

 

　　The second is the unreasonable production process settings or lack of control systems, resulting in differences in the quality of the same variety;

 

　　The third is that some varieties of preservatives, heavy metals, and pesticide residues exceed the limit;

 

　　Fourth, the quality control of raw medicinal materials and excipients is not strict, and some companies use adulterated and dyed raw medicinal materials and inferior excipients for the production of prescription preparations;

 

　　Fifth, poor compatibility of packaging materials affects product stability.

 

　　During the interview, the reporter also learned that for the 104 batches of non-compliant products detected, the State Food and Drug Administration has followed the supervision model of "risk control-legal disposal-investigation of reasons and rectification-information disclosure" to ensure risk closure and warning Medication is safe.
On the one hand, quickly organize drug regulatory authorities at all levels to promptly supervise relevant enterprises or units to take effective risk control measures such as recalls and suspension of production and sales, investigate and deal with the enterprises or units involved in accordance with the law, investigate the causes in depth, and completely eliminate hidden dangers; on the other hand; , In the form of notices, the non-compliant product information was released to the public in a timely manner in accordance with the law, and the public's drug safety defense line was established.
A total of 6 drug quality notices were issued throughout the year.
In response to the clues found in the exploratory research, the State Food and Drug Administration comprehensively researched and judged, and timely took control measures according to the risk level, organized targeted inspections on individual companies suspected of illegal production; for other general issues, adopted risk warnings and other measures Supervise and urge relevant enterprises to investigate and rectify.

 

　　2020 National Drug Sampling Inspection Variety Catalog

 

　　National Drug Sampling Inspection Annual Report (2020 )

 

　　Drug sampling is an important means of post-marketing supervision, and it plays an important role in cracking down on violations of laws and regulations, evaluating the quality of drugs, and ensuring the safety of drug use by the public.
In 2020, the State Food and Drug Administration will adhere to the “four strictest” guidelines and organize provincial drug administration departments and related inspection agencies to conduct random inspections on the quality of some drugs nationwide, and deepen the application of results, and continue Strengthen random inspection management and top-level design, improve the institutional system, integrate resources to form a supervisory force, and the effectiveness of service supervision has further emerged.
The results of random inspections in 2020 show that my country's current drug quality is still at a relatively high level, and the overall safety situation is stable and controllable.

 

　　I.
Overview

 

　　In order to implement the "Drug Administration Law of the People's Republic of China" and "The Vaccine Administration Law of the People's Republic of China", in 2020, in accordance with the "Administrative Measures for Drug Quality Random Inspection and Inspection" and other relevant requirements, the State Food and Drug Administration will focus on varieties and adhere to problem-oriented The principle of risk control is closely combined with the needs of supervision, and the annual sampling inspection plan and implementation plan are formulated.
The national drug sampling inspection adopts the work model of "decentralized sampling, centralized inspection, exploratory research, and comprehensive evaluation".
In accordance with the unified deployment of the State Food and Drug Administration, each provincial drug regulatory authority is responsible for organizing the sampling of samples in each administrative region, and the same variety All samples of the drug testing agency shall be centrally inspected by the same drug testing agency; after the testing agency confirms the receipt of the samples, it will use the method of "off-site settlement" to uniformly pay for the purchase of samples, and transmit the test results online in the form of an "electronic test report" to the relevant Provincial drug regulatory authority.
On the basis of statutory standard inspections, each inspection agency pays close attention to outstanding issues and conducts targeted exploratory research in combination with regulatory requirements, conducts "comprehensive physical examination" on randomized varieties, promptly discovers, prevents and controls hidden risks, and urges enterprises to implement quality and safety Subject responsibility.

 

　　In 2020, the national drug sampling inspection will complete 18013 batches of preparations and traditional Chinese medicine decoctions for 136 varieties.
The sample sources involve 3586 drug production and operation enterprises and users, covering 31 provinces, autonomous regions and municipalities in the country and the Xinjiang Production and Construction Corps.
47 drug inspection institutions undertake inspection and exploratory research tasks.
For the 104 batches of non-compliant products detected, the State Food and Drug Administration has followed the regulatory model of "risk control-legal disposal-investigation of causes and rectification-information disclosure" to ensure risk closure and warning of drug safety.
On the one hand, quickly organize drug regulatory authorities at all levels to promptly supervise relevant enterprises or units to take effective risk control measures such as recalls and suspension of production and sales, investigate and deal with the enterprises or units involved in accordance with the law, investigate the causes in depth, and completely eliminate hidden dangers; on the other hand; , In the form of notices, the non-compliant product information was released to the public in a timely manner in accordance with the law, and the public's drug safety defense line was established.
A total of 6 drug quality notices were issued throughout the year.
In response to the clues found in the exploratory research, the State Food and Drug Administration comprehensively researched and judged, and timely took control measures according to the risk level, organized targeted inspections on individual companies suspected of illegal production; for other general issues, adopted risk warnings and other measures Supervise and urge relevant enterprises to investigate and rectify.

 

　　2.
Sampling data analysis

 

　　(1) Sampling situation

 

　　2020136，77、48、83，45；18013，4106、13143764（1），1053、2186347，（、），23。

 

　

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　　Sampling data shows that the batches of pills and powders that do not meet the requirements account for a relatively high proportion.
The items that do not meet the requirements include identification and inspection.
The reasons for the non-compliance are mainly related to the adulteration of medicinal materials and the lack of strict preparation process control.
It reminds relevant companies that they should strengthen personnel Training, standardizing production management, strict process regulations and quality control of purchased medicinal materials.

 

　

　　Figure 7.
Schematic diagram of inspection information of each sampling link of Chinese patent medicine

 

　

　　Figure 8.
Distribution map of non-compliant items of Chinese patent medicines

 

　　(Note: Some non-compliant products involve multiple non-compliant items)

 

　　

　　Figure 9.
Schematic diagram of inspection information of each dosage form of Chinese patent medicine

 

　　3.
Biological products

 

　　In 2020, the National Drug Sampling Inspection will take a total of 90 batches of 3 varieties of biological products, including 1 therapeutic variety and 2 preventive varieties (see Figure 10).
The samples are all drawn from the production process, and the dosage forms are all injections.
After inspection, all inspected items are in compliance with the regulations, and the pass rate is 100%.

 

　

　　Figure 10.
Schematic diagram of biological product sampling information

 

　　4.
National Essential Medicines

 

　　In 2020, the National Drug Sampling Inspection will take a total of 6167 batches of 37 varieties of essential medicines (excluding Chinese herbal medicines), and 1260, 4625 and 282 batches of samples will be sampled in the production, operation and use links.
After inspection, 25 batches of non-compliant products were found, and 8 and 17 batches of non-compliant products were detected in the production and operation links, involving 4 dosage forms.

 

　

　　Figure 11.
Schematic diagram of inspection information for each sampling link of national essential medicines

 

　　

　　Figure 12.
Schematic diagram of inspection information of each dosage form of national essential medicines

 

　　5.
Special anti-viral Chinese patent medicine

 

　　In 2020, the national drug sampling inspection has set up a special antiviral Chinese patent medicine to effectively identify risks and ensure the quality of key antiviral Chinese patent medicines commonly used in clinical practice.

 

　　In 2020, a total of 932 batches of antiviral proprietary Chinese medicines were sampled, involving 5 dosage forms (Figure 13).
After inspection, 930 batches were in compliance with the regulations, with a pass rate of 99.
8%.
137, 790 and 5 batches of samples were taken in the production, operation and use stages, and 1 batch of non-compliant products was detected in the production and operation stages (Figure 14).

 

　　

　　Figure 13.
Schematic diagram of inspection information of each dosage form of antiviral Chinese patent medicine

 

　

　　Figure 14.
Schematic diagram of inspection information in each sampling link of the anti-viral Chinese patent medicine special project

 

　　(3) Special sampling inspection of Chinese herbal medicine

 

　　In 2020, the State Food and Drug Administration organized a special random inspection of Chinese herbal medicines.
The inspection and exploratory research are mainly aimed at the prominent problems of adulteration and adulteration in the traditional Chinese medicine decoction pieces whose sales have increased in recent years, as well as the quality problems caused by irregularities in planting/breeding, processing and processing.

 

　　In 2020, 1368 batches of 8 traditional Chinese medicine decoction pieces were sampled in the national drug sampling inspection.
After inspection, 1341 batches were in compliance with the regulations and 27 batches were not in compliance with the regulations (see Figure 15).
Non-compliance items mainly involve total ash content (2 batches), properties (23 batches), impurities (2 batches), identification (4 batches) and content determination (1 batch), etc.
, respectively accounting for all non-conformances 6.
3%, 71.
9%, 6.
3%, 12.
5% ​​and 3.
0% of the specified items (see Figure 16).

 

　　The main problems found in the national drug sampling inspections in 2020 are: first, the problem of adulteration and mixed use of genuine and counterfeit products, such as the mixing of some aconites in the production of Sichuan aconite; the second is the problem of excessive harmful residues, such as excessive pesticide residues in some batches of Peucedanum.
; Third, the harvesting and processing are not standardized.
For example, patchouli is not harvested according to the standard method, and some batches of yellow finishing processing are not standardized, causing the total ash content to exceed the standard.
Sampling inspection results suggest that relevant companies should standardize harvesting, processing and processing technology, strengthen inspections before entering the factory or feeding materials, strictly control storage and transportation conditions, control environmental humidity, and improve quality awareness.

 

　

　　Figure 15.
Schematic diagram of the results of special sampling of Chinese herbal medicine in 2020

 

　

　　Figure 16.
Distribution map of non-compliance items of special Chinese medicine decoction pieces in 2020

 

　　(Note: Some non-compliant products involve multiple non-compliant items)

 

　　 (4) Exploratory research

 

　　The main problems found in the exploratory study of national drug sampling inspections in 2020 are: first, illegal production, individual enterprises have low limits, excessive amounts or use alternative materials, violations of key manufacturing laws, lack of quality assurance systems, and problems such as production line pollution still exist; Unreasonable production process settings or lack of control systems have led to differences in the quality of the same variety; third, some varieties of preservatives, heavy metals, and pesticide residues exceed the limit; fourth, the quality control of raw medicinal materials and excipients is not strict, and some companies use adulteration and dyeing The original medicinal materials and inferior excipients are used in the production of prescription preparations; fifth, the poor compatibility of packaging materials affects product stability.

 

　　3.
Application of sampling results

 

　　Drug sampling inspection is a random inspection conducted by the drug supervision and administration department in accordance with the law on the production, operation, and use of drugs and their responsible entities in accordance with the needs of supervision.
Its fundamental purpose is to identify prevention and control risks and eliminate potential safety hazards.
In 2020, the drug regulatory authorities will make full use of the national drug sampling inspection results to severely crack down on the manufacture and sale of counterfeit and inferior drugs, continue to promote the innovation of regulatory mechanisms and the in-depth use of sampling data, improve the drug sampling management system, and improve risk prevention and control capabilities.

 

　　One is to strictly verify and dispose of.
In 2020, the targeted nature of national drug sampling will be further improved.
Based on the sampling data of previous years, we will increase the intensity of sampling in circulation to ensure the quality of the drugs in the business and use units; at the same time, select antiviral Chinese patent medicines with a large clinical use and a wide range of applications.
Special sampling inspections were set up.
A total of 932 batches of antiviral Chinese patent medicines were selected throughout the year to investigate potential hidden dangers and effectively reduce regional and systemic risks.
Regarding 104 batches of non-compliant products, the State Food and Drug Administration has firmly established risk awareness, immediately adopted control measures such as seizures, suspension of sales, and organized various provincial drug administration departments to investigate and deal with the enterprises or units involved.
, To effectively deter illegal companies and purify the market environment.

 

　　The second is to form a regulatory force.
In order to improve the effectiveness of service supervision of drug sampling inspections, in 2020, the State Food and Drug Administration will continue to promote the in-depth use of sampling data, and organically link the results of sampling inspections with inspections, inspections and law enforcement, and form a combined force of supervision.
For example, an exploratory study found that some batches of compound ammonium glycyrrhizinate injections exceeded the limit, and individual companies were found to be suspected of overdosing in violation of regulations after inspection; during the inspection, it was found that some batches of Yuanhu Pain Relief Tablets contained auramine O.
It was found that individual companies did not have strict quality control and used poor-quality medicinal materials.
The continuously improved inspection and research level and the efficient and coordinated quality supervision system have effectively curbed the fluke psychology of individual enterprises and improved their awareness of quality and safety.

 

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　　The results of sampling of pharmaceutical preparations showed that a total of 16645 batches of preparation products were sampled, 16568 batches of products were in compliance with regulations, and 77 batches of products were not in compliance with regulations.
Among them, auramine O was detected in 2 batches of samples in accordance with the supplementary inspection method.
Among the 128 varieties sampled, there were 106 preparations with all samples in compliance with the regulations, a total of 13,179 batches.
Among them, there are 8046 batches of 64 varieties of chemical drugs, 5043 batches of 39 varieties of Chinese patent medicines, and 90 batches of 3 varieties of biological products.

 

　　The results of sampling of proprietary Chinese medicines showed that a total of 6338 batches of 48 varieties were sampled, involving 12 formulations, and 1072, 5197, and 69 batches of samples were taken during production, operation and use.
After inspection, 6304 batches were in compliance with the regulations, 34 batches were not in compliance with the regulations (including 2 batches of products that were not in compliance with the regulations by the supplementary inspection method), and 1 and 33 batches of non-compliant products were detected in the production and operation links respectively.
It accounts for 0.
1% and 0.
6% of all samples in the corresponding link.

 

　　The results of the sampling of biological products showed that there were 90 batches of 3 varieties, including 1 for the treatment type and 2 for the prevention type.
The samples are all drawn from the production process, and the dosage forms are all injections.
After inspection, all inspected items are in compliance with the regulations, and the pass rate is 100%.

 

　　The results of the national essential medicine sampling show that a total of 6167 batches of 37 varieties were sampled, and 1260, 4625 and 282 batches of samples were sampled in the production, operation and use links.
After inspection, 25 batches of non-compliant products were found, and 8 and 17 batches of non-compliant products were detected in the production and operation links, involving 4 dosage forms.

 

　　The results of special sampling of antiviral Chinese patent medicines showed that a total of 932 batches of antiviral Chinese patent medicines were sampled, involving 5 dosage forms.
After inspection, 930 batches were in compliance with the regulations, with a pass rate of 99.
8%.

 

　　The results of special sampling of Chinese herbal medicines showed that a total of 1,368 batches of 8 Chinese herbal medicines were sampled.
After inspection, 1341 batches were in compliance with regulations and 27 batches were not in compliance with regulations.

 

　　Exploratory research found five major problems

 

　　The main problems found in the exploratory study of national drug sampling in 2020 are:

 

　　The first is production in violation of laws and regulations, individual enterprises have low limits, excessive amounts or use substitutes to feed materials, violation of key manufacturing laws, lack of quality assurance systems, and problems such as production line pollution still exist;

 

　　The second is the unreasonable production process settings or lack of control systems, resulting in differences in the quality of the same variety;

 

　　The third is that some varieties of preservatives, heavy metals, and pesticide residues exceed the limit;

 

　　Fourth, the quality control of raw medicinal materials and excipients is not strict, and some companies use adulterated and dyed raw medicinal materials and inferior excipients for the production of prescription preparations;

 

　　Fifth, poor compatibility of packaging materials affects product stability.

 

　　During the interview, the reporter also learned that for the 104 batches of non-compliant products detected, the State Food and Drug Administration has followed the supervision model of "risk control-legal disposal-investigation of reasons and rectification-information disclosure" to ensure risk closure and warning Medication is safe.
On the one hand, quickly organize drug regulatory authorities at all levels to promptly supervise relevant enterprises or units to take effective risk control measures such as recalls and suspension of production and sales, investigate and deal with the enterprises or units involved in accordance with the law, investigate the causes in depth, and completely eliminate hidden dangers; on the other hand; , In the form of notices, the non-compliant product information was released to the public in a timely manner in accordance with the law, and the public's drug safety defense line was established.
A total of 6 drug quality notices were issued throughout the year.
In response to the clues found in the exploratory research, the State Food and Drug Administration comprehensively researched and judged, and timely took control measures according to the risk level, organized targeted inspections on individual companies suspected of illegal production; for other general issues, adopted risk warnings and other measures Supervise and urge relevant enterprises to investigate and rectify.

 

　　2020 National Drug Sampling Inspection Variety Catalog

 

　　National Drug Sampling Inspection Annual Report (2020 )

 

　　Drug sampling is an important means of post-marketing supervision, and it plays an important role in cracking down on violations of laws and regulations, evaluating the quality of drugs, and ensuring the safety of drug use by the public.
In 2020, the State Food and Drug Administration will adhere to the “four strictest” guidelines and organize provincial drug administration departments and related inspection agencies to conduct random inspections on the quality of some drugs nationwide, and deepen the application of results, and continue Strengthen random inspection management and top-level design, improve the institutional system, integrate resources to form a supervisory force, and the effectiveness of service supervision has further emerged.
The results of random inspections in 2020 show that my country's current drug quality is still at a relatively high level, and the overall safety situation is stable and controllable.

 

　　I.
Overview

 

　　In order to implement the "Drug Administration Law of the People's Republic of China" and "The Vaccine Administration Law of the People's Republic of China", in 2020, in accordance with the "Administrative Measures for Drug Quality Random Inspection and Inspection" and other relevant requirements, the State Food and Drug Administration will focus on varieties and adhere to problem-oriented The principle of risk control is closely combined with the needs of supervision, and the annual sampling inspection plan and implementation plan are formulated.
The national drug sampling inspection adopts the work model of "decentralized sampling, centralized inspection, exploratory research, and comprehensive evaluation".
In accordance with the unified deployment of the State Food and Drug Administration, each provincial drug regulatory authority is responsible for organizing the sampling of samples in each administrative region, and the same variety All samples of the drug testing agency shall be centrally inspected by the same drug testing agency; after the testing agency confirms the receipt of the samples, it will use the method of "off-site settlement" to uniformly pay for the purchase of samples, and transmit the test results online in the form of an "electronic test report" to the relevant Provincial drug regulatory authority.
On the basis of statutory standard inspections, each inspection agency pays close attention to outstanding issues and conducts targeted exploratory research in combination with regulatory requirements, conducts "comprehensive physical examination" on randomized varieties, promptly discovers, prevents and controls hidden risks, and urges enterprises to implement quality and safety Subject responsibility.

 

　　In 2020, the national drug sampling inspection will complete 18013 batches of preparations and traditional Chinese medicine decoctions for 136 varieties.
The sample sources involve 3586 drug production and operation enterprises and users, covering 31 provinces, autonomous regions and municipalities in the country and the Xinjiang Production and Construction Corps.
47 drug inspection institutions undertake inspection and exploratory research tasks.
For the 104 batches of non-compliant products detected, the State Food and Drug Administration has followed the regulatory model of "risk control-legal disposal-investigation of causes and rectification-information disclosure" to ensure risk closure and warning of drug safety.
On the one hand, quickly organize drug regulatory authorities at all levels to promptly supervise relevant enterprises or units to take effective risk control measures such as recalls and suspension of production and sales, investigate and deal with the enterprises or units involved in accordance with the law, investigate the causes in depth, and completely eliminate hidden dangers; on the other hand; , In the form of notices, the non-compliant product information was released to the public in a timely manner in accordance with the law, and the public's drug safety defense line was established.
A total of 6 drug quality notices were issued throughout the year.
In response to the clues found in the exploratory research, the State Food and Drug Administration comprehensively researched and judged, and timely took control measures according to the risk level, organized targeted inspections on individual companies suspected of illegal production; for other general issues, adopted risk warnings and other measures Supervise and urge relevant enterprises to investigate and rectify.

 

　　2.
Sampling data analysis

 

　　(1) Sampling situation

 

　　In 2020, the national drug sampling inspection will take a total of 136 varieties of preparation products and traditional Chinese medicine pieces, including 77 chemical drugs, 48 ​​Chinese patent medicines, 8 traditional Chinese medicine pieces and 3 biological products, including 45 national essential medicines; a total of 18013 batches of samples will be sampled Times, including 4106 batches in the production process, 13143 batches in the business process, and 764 batches in the use process (see Figure 1), involving 1053 drug manufacturing companies, 2186 drug trading companies, and 347 drug users.
All provinces (regions, cities) ) The sampling situation of the samples and the sampling distribution of the label production companies in the area where the samples are taken are shown in Figure 2 and Figure 3, respectively.

 

　

　　Figure 1.
Sampling situation of production, operation and use

 

　

　　Figure 2.
Distribution of sample sources for sampling

 

　　(Note: The numbers in the figure refer to the number of sampled batches in each province, and the colors from light to dark indicate the number of sampled batches from low to high)

 

　

　　Figure 3.
Distribution map of sampling sample origin

 

　　(2) Data analysis of random inspection of pharmaceutical preparations

 

　　A total of 16,645 batches of preparation products will be sampled for national drug inspections in 2020.
After inspection, 16568 batches of products meet the requirements, 77 batches of products do not meet the requirements, of which 2 batches of samples were tested and found auramine O in accordance with the supplementary inspection method.
Among the 128 varieties sampled, there were 106 preparations with all samples in compliance with the regulations, a total of 13,179 batches.
Among them, there are 8046 batches of 64 varieties of chemical drugs, 5043 batches of 39 varieties of Chinese patent medicines, and 90 batches of 3 varieties of biological products.

 

　　1.
Chemicals

 

　　In 2020, the National Drug Sampling Inspection will take a total of 10,217 batches of 77 varieties of chemical drugs, involving 2370 batches in the production process, 7322 batches in the business process and 525 batches in the use process.
After inspection, 43 batches of non-compliant products were found to be non-compliant, and 15, 27 and 1 batches of non-compliant products were detected in the production, operation and use links, accounting for 0.
6%, 0.
4% and 0.
2% of all samples in the corresponding links (see Figure 4).
).

 

　　In 2020, the national drug sampling inspection involved a total of 18 dosage forms, and a total of 8 dosage forms had non-compliant products.
Among them, sterile powder for injection (28 batches), tablets (7 batches), capsules (2 batches), enteric-coated tablets (2 batches), granules (1 batch), injections (1 batch) Batch), oral solution (1 batch), and sustained-release tablets (1 batch), respectively accounting for 1.
5%, 0.
3%, 0.
2%, 0.
9%, 0.
2%, 0.
1%, 0.
4% of all products in the corresponding dosage form And 1.
6% (see Figure 5).

 

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3%、95.
4%2.
3%（6）。

 

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6%（7）。

 

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0%、5.
7%、42.
9%5.
7%（8）。

 

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0%、0.
5%、0.
4%、2.
7%、0.
1%（9）。

 

　　Sampling data shows that the batches of pills and powders that do not meet the requirements account for a relatively high proportion.
The items that do not meet the requirements include identification and inspection.
The reasons for the non-compliance are mainly related to the adulteration of medicinal materials and the lack of strict preparation process control.
It reminds relevant companies that they should strengthen personnel Training, standardizing production management, strict process regulations and quality control of purchased medicinal materials.

 

　

　　Figure 7.
Schematic diagram of inspection information of each sampling link of Chinese patent medicine

 

　

　　Figure 8.
Distribution map of non-compliant items of Chinese patent medicines

 

　　(Note: Some non-compliant products involve multiple non-compliant items)

 

　　

　　Figure 9.
Schematic diagram of inspection information of each dosage form of Chinese patent medicine

 

　　3.
Biological products

 

　　In 2020, the National Drug Sampling Inspection will take a total of 90 batches of 3 varieties of biological products, including 1 therapeutic variety and 2 preventive varieties (see Figure 10).
The samples are all drawn from the production process, and the dosage forms are all injections.
After inspection, all inspected items are in compliance with the regulations, and the pass rate is 100%.

 

　

　　Figure 10.
Schematic diagram of biological product sampling information

 

　　4.
National Essential Medicines

 

　　In 2020, the National Drug Sampling Inspection will take a total of 6167 batches of 37 varieties of essential medicines (excluding Chinese herbal medicines), and 1260, 4625 and 282 batches of samples will be sampled in the production, operation and use links.
After inspection, 25 batches of non-compliant products were found, and 8 and 17 batches of non-compliant products were detected in the production and operation links, involving 4 dosage forms.

 

　

　　Figure 11.
Schematic diagram of inspection information for each sampling link of national essential medicines

 

　　

　　Figure 12.
Schematic diagram of inspection information of each dosage form of national essential medicines

 

　　5.
Special anti-viral Chinese patent medicine

 

　　In 2020, the national drug sampling inspection has set up a special antiviral Chinese patent medicine to effectively identify risks and ensure the quality of key antiviral Chinese patent medicines commonly used in clinical practice.

 

　　In 2020, a total of 932 batches of antiviral proprietary Chinese medicines were sampled, involving 5 dosage forms (Figure 13).
After inspection, 930 batches were in compliance with the regulations, with a pass rate of 99.
8%.
137, 790 and 5 batches of samples were taken in the production, operation and use stages, and 1 batch of non-compliant products was detected in the production and operation stages (Figure 14).

 

　　

　　Figure 13.
Schematic diagram of inspection information of each dosage form of antiviral Chinese patent medicine

 

　

　　Figure 14.
Schematic diagram of inspection information in each sampling link of the anti-viral Chinese patent medicine special project

 

　　(3) Special sampling inspection of Chinese herbal medicine

 

　　In 2020, the State Food and Drug Administration organized a special random inspection of Chinese herbal medicines.
The inspection and exploratory research are mainly aimed at the prominent problems of adulteration and adulteration in the traditional Chinese medicine decoction pieces whose sales have increased in recent years, as well as the quality problems caused by irregularities in planting/breeding, processing and processing.

 

　　In 2020, 1368 batches of 8 traditional Chinese medicine decoction pieces were sampled in the national drug sampling inspection.
After inspection, 1341 batches were in compliance with the regulations and 27 batches were not in compliance with the regulations (see Figure 15).
Non-compliance items mainly involve total ash content (2 batches), properties (23 batches), impurities (2 batches), identification (4 batches) and content determination (1 batch), etc.
, respectively accounting for all non-conformances 6.
3%, 71.
9%, 6.
3%, 12.
5% ​​and 3.
0% of the specified items (see Figure 16).

 

　　The main problems found in the national drug sampling inspections in 2020 are: first, the problem of adulteration and mixed use of genuine and counterfeit products, such as the mixing of some aconites in the production of Sichuan aconite; the second is the problem of excessive harmful residues, such as excessive pesticide residues in some batches of Peucedanum.
; Third, the harvesting and processing are not standardized.
For example, patchouli is not harvested according to the standard method, and some batches of yellow finishing processing are not standardized, causing the total ash content to exceed the standard.
Sampling inspection results suggest that relevant companies should standardize harvesting, processing and processing technology, strengthen inspections before entering the factory or feeding materials, strictly control storage and transportation conditions, control environmental humidity, and improve quality awareness.

 

　

　　Figure 15.
Schematic diagram of the results of special sampling of Chinese herbal medicine in 2020

 

　

　　Figure 16.
Distribution map of non-compliance items of special Chinese medicine decoction pieces in 2020

 

　　(Note: Some non-compliant products involve multiple non-compliant items)

 

　　 (4) Exploratory research

 

　　The main problems found in the exploratory study of national drug sampling inspections in 2020 are: first, illegal production, individual enterprises have low limits, excessive amounts or use alternative materials, violations of key manufacturing laws, lack of quality assurance systems, and problems such as production line pollution still exist; Unreasonable production process settings or lack of control systems have led to differences in the quality of the same variety; third, some varieties of preservatives, heavy metals, and pesticide residues exceed the limit; fourth, the quality control of raw medicinal materials and excipients is not strict, and some companies use adulteration and dyeing The original medicinal materials and inferior excipients are used in the production of prescription preparations; fifth, the poor compatibility of packaging materials affects product stability.

 

　　3.
Application of sampling results

 

　　Drug sampling inspection is a random inspection conducted by the drug supervision and administration department in accordance with the law on the production, operation, and use of drugs and their responsible entities in accordance with the needs of supervision.
Its fundamental purpose is to identify prevention and control risks and eliminate potential safety hazards.
In 2020, the drug regulatory authorities will make full use of the national drug sampling inspection results to severely crack down on the manufacture and sale of counterfeit and inferior drugs, continue to promote the innovation of regulatory mechanisms and the in-depth use of sampling data, improve the drug sampling management system, and improve risk prevention and control capabilities.

 

　　One is to strictly verify and dispose of.
In 2020, the targeted nature of national drug sampling will be further improved.
Based on the sampling data of previous years, we will increase the intensity of sampling in circulation to ensure the quality of the drugs in the business and use units; at the same time, select antiviral Chinese patent medicines with a large clinical use and a wide range of applications.
Special sampling inspections were set up.
A total of 932 batches of antiviral Chinese patent medicines were selected throughout the year to investigate potential hidden dangers and effectively reduce regional and systemic risks.
Regarding 104 batches of non-compliant products, the State Food and Drug Administration has firmly established risk awareness, immediately adopted control measures such as seizures, suspension of sales, and organized various provincial drug administration departments to investigate and deal with the enterprises or units involved.
, To effectively deter illegal companies and purify the market environment.

 

　　The second is to form a regulatory force.
In order to improve the effectiveness of service supervision of drug sampling inspections, in 2020, the State Food and Drug Administration will continue to promote the in-depth use of sampling data, and organically link the results of sampling inspections with inspections, inspections and law enforcement, and form a combined force of supervision.
For example, an exploratory study found that some batches of compound ammonium glycyrrhizinate injections exceeded the limit, and individual companies were found to be suspected of overdosing in violation of regulations after inspection; during the inspection, it was found that some batches of Yuanhu Pain Relief Tablets contained auramine O.
It was found that individual companies did not have strict quality control and used poor-quality medicinal materials.
The continuously improved inspection and research level and the efficient and coordinated quality supervision system have effectively curbed the fluke psychology of individual enterprises and improved their awareness of quality and safety.

 

　　The third is to improve the institutional system.
The newly revised "Drug Administration Law of the People's Republic of China", "Administrative Measures for Drug Quality Sampling Inspection" and "Drug Sampling Principles and Procedures" put forward higher requirements for drug sampling.
In 2020, the State Food and Drug Administration will organize relevant units to improve the system management system and innovate regulatory methods and methods.
On the one hand, the original notice documents will be optimized and integrated, and the “Notice of the State Food and Drug Administration on Further Strengthening the Administration of National Drug Sampling Inspections” will be issued.
Several working procedures have been formulated, and a new management document system that is connected and linked up and down has been established to smooth the internal circulation of the management system; on the other hand, an expert analysis and judgment mechanism has been established to select varieties, objections, appeals, and quality evaluations involved in the full cycle of drug sampling We will conduct comprehensive research and judgment to ensure the scientific nature of various measures.
At present, there are more than 500 experts from various fields such as supervision, inspection, review and inspection, adverse reaction monitoring, and standard setting in the drug sampling expert database .

 

　　The fourth is to strengthen informatization construction.
In order to improve the level of smart supervision, under the leadership of the State Food and Drug Administration, the China Inspection Institute further improved the construction of the national drug sampling information platform, fully integrated the latest information technology, and realized the online transmission of inspection reports and other related documents to ensure data release and information transmission Uniformity and standardization; build instant push and risk warning modules to track work tasks at any time and automatically analyze sampling data.
Up to now, the national drug sampling inspection work has realized the full life cycle, real-time online management from product selection to verification and disposal.
In addition, in order to promote data transformation and empowerment, the platform has opened up and shared the accumulated massive data and in-depth research reports to relevant units.
It has now included more than 1.
54 million pieces of random inspection information, quality analysis reports, annual quality status reports, special research reports, etc.
Thousands of books provide an important reference for review and inspection, standard improvement and other regulatory decisions.
The continuous improvement of the level of informatization construction has greatly improved the efficiency of sampling inspection work, and at the same time provides strong technical support for the smooth implementation of new policies and new requirements such as sample purchase.

 

　　The fifth is to promote high-quality development.
Regarding the general issues found in the exploratory research, the drug regulatory authority will provide feedback to the relevant companies in the form of "drug quality reminders" to continuously promote the implementation of the main responsibilities of the companies and urge the companies to improve the quality assurance system.
For example, the exploratory study of Xiaoshuan Zaizao Pills suggests that the decrease in the content of volatile components in some batches of products may be related to the excessively long storage time after powdering the original medicinal materials; the exploratory study of furosemide injection found that the packaging selected by some companies Materials can affect drug stability.
On this basis, the China National Inspection and Quarantine Institute continues to disclose the exploratory research status of national drug sampling inspections on its official website.
In 2020, a total of 63 varieties of new inspection methods, contact information, etc.
will be released to facilitate the sharing and utilization of related units and focus on the quality of the discovered drugs.
Issues and new technologies for inspection and testing are exchanged to promote the high-quality development of the industry.

 

　　The sixth is to build a platform for co-governance.
In order to deepen information disclosure and promote social governance, in 2020, the State Food and Drug Administration will continue to publish information on non-compliant products to the whole society in the form of circulars; at the same time, the State Food and Drug Administration website will open a sampling information query platform to disclose the country The results of drug sampling and related data inquiries have been provided.
At present, more than 15,000 non-compliant drug data have been collected.
In December 2020, the annual "Drug Quality and Safety Annual Conference" will be held online.
Based on the results of national drug sampling, the annual conference will analyze the quality of drugs, share the latest inspection and testing technologies, and help companies improve their quality management.
Inspection institutions and related enterprises have established communication platforms to further consolidate the main responsibility of enterprises and enhance the effectiveness of supervision.

 

　　Fourth, the conclusion

 

　　In 2020, the national drug regulatory authorities will earnestly implement the decisions and deployments of the Party Central Committee, the State Council and the relevant work requirements of the State Drug Administration, adhere to the people's supremacy, ensure the safety and effectiveness of drug use, help epidemic prevention and control, and successfully complete national drug sampling inspections.
Inspection and research results show that the quality of medicines in my country is still at a relatively high level, and the overall safety situation is stable and controllable.

 

　　2021 is the first year of the "14th Five-Year Plan" and a crucial year for ushering in the dawn of the post-epidemic era.
The State Food and Drug Administration will continue to do a good job of prevention and control of the epidemic, solidly make decisions and deployments such as the “six stability” and “six guarantees”, adhere to the improvement of the drug sampling management system, and continue to innovate the regulatory systems, mechanisms, methods and methods.
Implement the "Pharmaceutical Administration Law of the People's Republic of China" and the "Vaccine Administration Law of the People's Republic of China", coordinate and efficiently carry out drug sampling under the new situation, and strive to ensure the stability of drug safety.

 

　　Tips

 

　　1.
Historical evolution of drug sampling

 

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