The State Food and Drug Administration announced the third batch of typical cases of special rectification of drug safety

Since the beginning of this year, in order to implement the decision-making and deployment of the Party Central Committee and the State Council on strengthening drug safety, the State Food and Drug Administration has organized and carried out special rectification actions
for drug safety nationwide with strict investigation of violations and strict control of risks as the main line.
Local drug regulatory departments have continued to strengthen supervision and law enforcement, severely cracked down on illegal acts endangering drug safety, investigated and dealt with a number of cases of violations of laws and regulations, and effectively protected the health of the people and drug safety
.
The third batch of typical cases
of special rectification of drug safety is hereby announced.

 

1.
Ningbo High-tech Zone Jushan Fushi Health Information Consultation Center operated drugs without permission and did not obtain approval documents

 

Brief Facts of the Case

 

In 2021, the National High-tech District Bureau of the Ningbo Municipal Administration for Market Supervision in Zhejiang Province, based on clues reported by the masses, inspected the Jushan Fushi Health Information Consultation Center in Ningbo High-tech Zone and found that the institution sold cold Jingfang pills and other drugs through WeChat groups without obtaining drug approval documents without obtaining a Drug Business License without obtaining a Drug Business License, with a value of 42,000 yuan
.
The above acts violate the provisions
of the first paragraph of Article 51 and the fourth paragraph of Article 98 of the Drug Administration Law.
In April 2022, in accordance with Articles 115 and 124, paragraphs 1 and 2 of the Drug Administration Law, the High-tech District Bureau imposed administrative penalties
of confiscating the drugs involved in the case, confiscating 6,730 yuan of illegal gains, and fining 1.
5 million yuan.

 

Typical significance

 

The Drug Administration Law implements a strict market access system for drugs and a strict licensing system for the production and trading activities
of drugs.
In this case, the parties took advantage of the misunderstanding of the middle-aged and elderly groups that traditional Chinese medicines had no side effects, and shared the so-called "cure cases" through the online new media "WeChat group", publicizing unapproved proprietary Chinese medicines as "miracle medicines" for curing diseases, which delayed the disease at worst and endangered life
in the worst.
At the same time, illegal sales through WeChat are highly concealed and not easy to detect, bringing serious hidden dangers
to medication safety.
In this case, the drug regulatory authorities severely punished the parties for their illegal acts, effectively deterred the illegal acts of using "WeChat groups" and other networks to sell fake and inferior drugs, and demonstrated the determination
of the drug regulatory authorities to implement the "four strictest".

 

2.
Guangzhou Grand Hyatt Pharmacy Chain Co.
, Ltd.
illegally sold drugs

 

Brief Facts of the Case

 

In October 2021, when the Market Supervision Administration of Huadu District of Guangzhou City, Guangdong Province, based on the clues of the report, inspected Guangzhou Grand Hyatt Pharmacy Chain Co.
, Ltd.
, it was found that the company had manually queued up to obtain preparations from medical institutions such as "dimethicone cream" and "skin cream" from regular medical institutions with prescriptions, and sold them through the "Grand Hyatt Pharmacy Flagship Store" of Jingdong Mall, with the value of the drugs involved in the case being 148,700 yuan
.
The above acts violate the provisions
of Article 55 and Article 76, paragraph 3 of the Drug Administration Law.
In March 2022, in accordance with Article 129 of the Drug Administration Law, the Huadu District Market Supervision Administration imposed an administrative penalty
of confiscating 148,700 yuan of illegal gains and fining 446,300 yuan on the company.

 

Typical significance

 

Medical institution preparations refer to fixed prescription preparations prepared by medical institutions for their own use according to the approval of this clinical need, which play an important role in ensuring clinical medical needs, making up for the shortage of clinical drugs, promoting public health, and helping the development of new drugs, and are an important part and necessary supplement
to the national pharmaceutical industry.
Article 76 of the Drug Administration Law stipulates that "preparations prepared by medical institutions shall not be sold on the market"
.
In this case, the parties publicly sold preparations prepared by medical institutions nationwide through online platforms, resulting in the flow of in-hospital preparations to the market, which in turn caused the public to use drugs without the guidance of physicians, which brought great hidden dangers
to the safety of public medication.
The drug regulatory authorities have strictly investigated and dealt with them in accordance with the law through various methods such as network monitoring, effectively ensuring the safety and effectiveness
of public drug use.

 

3.
The case of Pingluo County Hospital of Traditional Chinese Medicine in Shizuishan City, Ningxia Hui Autonomous Region, failing to purchase drugs from drug marketing authorization holders or enterprises with pharmaceutical production and trading qualifications

 

Brief Facts of the Case

 

In November 2021, the Market Supervision Administration of Pingluo County, Shizuishan City, Ningxia Hui Autonomous Region, found that Pingluo County Traditional Chinese Medicine Hospital had illegally purchased agarwood and other traditional Chinese medicine pieces from drug marketing authorization holders or enterprises with pharmaceutical production and business qualifications, and the value of the goods involved was 483,600 yuan
.
The above behavior violates Article 55 of
the Drug Administration Law.
In April 2022, in accordance with Article 129 of the Drug Administration Law, Article 32 of the Administrative Punishment Law of the People's Republic of China and Article 10 of the Rules for the Application of Discretionary Administrative Penalties for Drugs, Medical Devices and Cosmetics in Ningxia Hui Autonomous Region (for Trial Implementation), the Pingluo County Market Supervision Administration ordered the hospital to correct the above-mentioned illegal acts, and imposed the confiscation of 50.
84 kg of Chinese medicine pieces involved in the case, confiscation of 472,300 yuan of illegal gains, An administrative penalty
of 967,300 yuan.

 

Typical significance

 

Criminals purchase Chinese medicine pieces through illegal channels, and by printing out the warehouse slip by themselves, they are affiliated with regular enterprises to carry out illegal business of Chinese medicine pieces
.
In this case, the party Pingluo County Traditional Chinese Medicine Hospital did not fully perform its obligation of purchase inspection and acceptance, failed to check the consistency of the tax invoice sales list and the consistency of the template style of the outbound bill with the goods, and did not purchase and use Chinese medicine pieces from the drug marketing authorization holder or enterprises with pharmaceutical production and business qualifications, resulting in the inability to trace the origin of the relevant drugs, which brought major hidden dangers
to the safety of the public's medication 。 The drug regulatory department analyzed and sorted out the hospital's accompanying bills and tax stamp information, and used methods such as assistance in investigation to verify the illegal acts of the parties, which effectively cracked down on and deterred illegal acts in the pharmaceutical field, and was conducive to further standardizing and promoting the healthy development of
the pharmaceutical industry.

 

4.
Zaoqiang County Yanmei Beauty Studio operated drugs without a license

 

Brief Facts of the Case

 

In February 2022, when the Market Supervision Administration of Zaoqiang County, Hengshui City, Hebei Province conducted a daily supervision and inspection of the Zaoqiang County Yanmei Beauty Studio, it was found that the studio had not obtained the "Drug Business License" to sell drugs such as Removing Speckle Capsules, and the value of the drugs involved was 55,600 yuan
.
The above acts violate the provisions
of the first paragraph of Article 51 of the Drug Administration Law.
In June 2022, in accordance with Article 115 of the Drug Administration Law and Article 14 of the Rules for the Application of Discretionary Administrative Penalties for Market Supervision and Administration of Hebei Province, the Zaoqiang County Market Supervision Administration imposed administrative penalties
of ordering the parties to close, confiscate the drugs involved in the case, confiscate 32,153.
5 yuan of illegal gains, and fine 300,000 yuan.

 

Typical significance

 

China's laws implement a strict licensing management system for pharmaceutical business activities, and it is forbidden to engage in pharmaceutical business activities
without obtaining a drug business license.
In this case, the original site of the studio was a beauty clinic, and after the clinic was relocated, the beauty studio still operated drugs without the "Drug Business License" and took advantage of the trust of consumers, which not only seriously hindered the healthy development of the pharmaceutical retail industry, but also posed a threat
to the safety of people's medication.
The punishment of drug regulatory departments in accordance with law has a positive exemplary effect on effectively curbing relevant illegal activities, is conducive to standardizing the order of drug circulation, and effectively ensuring the safety
of people's drug use.

 

5.
The case of Hua Wei Hospital of Chongqing Wansheng Economic and Technological Development Zone using medical devices that are not registered according to law

 

Brief Facts of the Case

 

On December 14, 2021, the Market Supervision and Administration Bureau of Chongqing Wansheng Economic and Technological Development Zone conducted an investigation
into the use of smuggled and renovated old color ultrasound in Hua Wei Hospital of Chongqing Wansheng Economic and Technological Development Zone based on the clues reported by the anti-smuggling department of the customs.
After investigation, the color ultrasound diagnostic instrument system used by the parties to identify a certain brand was the purchase of refurbished foreign used medical devices, with a value of 680,000 yuan and a total of 187,330,750 yuan
of illegal gains.
The use of medical devices that have not been registered in accordance with the law violates Article 55 of the Regulations on the Supervision and Administration of
Medical Devices (State Council Order No.
739).
。 On January 29, 2022, the Market Supervision and Administration Bureau of Wansheng Economic and Technological Development Zone decided to give the parties a mitigated penalty and imposed an administrative penalty of confiscating the products involved in the case and illegal gains of 187,330,075 yuan and a fine of 1.
02 million yuan, in accordance with the provisions of Item 3 of the first paragraph of Article 86 of the Regulations on the Supervision and Administration of Medical Devices (State Council Order No.
739) and the Guiding Opinions on Regulating the Discretionary Power of Administrative Penalties for Market Supervision and Administration (Guo Municipal Supervision Law [2019] No.
244).

。

 

Typical significance

 

This case is a typical case in which the anti-smuggling department of customs handed over the illegal clues found during the crackdown on criminal offenses to the administrative organs, and the administrative organs investigated and dealt with them ex officio, reflecting the importance of the linkage and complementary mechanisms of
execution and punishment in combating illegal and criminal acts.
Article 55 of the Regulations on the Supervision and Administration of Medical Devices stipulates that medical device trading enterprises and users shall not operate or use medical devices
that have not been registered or filed in accordance with the law, have no certificate of conformity, and have expired, expired, invalid, or eliminated.
The purchase and use of refurbished medical devices that have been used abroad disrupted the normal import order, posed a major safety hazard, and easily caused the risk
of missing or misdiagnosis and aggravating the patient's condition.
The investigation and handling of this case demonstrates the determination
of the drug regulatory department to maintain the order of supervision and management of medical devices and ensure the safety of the people's use of equipment.

 

6.
Guangzhou Inomi Medical Equipment Co.
, Ltd.
operated Class III medical devices without obtaining a medical device registration certificate

 

Brief Facts of the Case

 

In July 2020, the Market Supervision Administration of Tianhe District, Guangzhou City, Guangdong Province, inspected Guangzhou Inomi Medical Device Co.
, Ltd.
based on the clues reported by the masses, and found that the parties operated 3 "cryolipolytic SPA beauty machines" of Class III medical devices that did not obtain a medical device registration certificate between November 2016 and July 2019, with a value of 770,000 yuan and illegal income of 332,686,420 yuan
.
The conduct of the parties dealing in Class III medical devices without obtaining a medical device registration certificate violated Article 40 of the Regulations on the Supervision and Administration of Medical Devices (Order No.
680 of
the State Council).
In June 2022, in accordance with Article 63, Paragraph 1, Item 1 of the Regulations on the Supervision and Administration of Medical Devices (State Council Order No.
680), the Guangzhou Tianhe District Market Supervision Administration imposed an administrative penalty
of confiscating 332,686,42 yuan of illegal gains and fining 7.
7 million yuan on the parties.

 

Typical significance

 

With the improvement of people's living standards, the market demand for medical device products for medical cosmetology is large
.
The parties in this case used ordinary electrical appliances to declare the import of the products involved in the case, and the products involved in the case did not have Chinese markings
.
The case-handling department notarized the translation of the foreign language instruction manual of the product involved in the case, and combined with the product description and intended use of the translated product, it was clarified that the product involved was a cryolipolytic device, which belonged to Class III medical devices
.
According to the Regulations on the Supervision and Administration of Medical Devices, Class III medical devices are subject to product registration management, and medical device trading enterprises shall not operate medical devices
that are not registered according to law.
Since the illegal business conduct of the parties occurred between November 2016 and July 2019, the case-handling department applied the Regulations on the Supervision and Administration of Medical Devices (State Council Order No.
680) in force at the time (State Council Order No.
680 came into force on May 4, 2017 and was replaced by State Council Order No.
739 on June 1, 2021).

The investigation and handling of this case provides a model for the investigation and handling of the same type of case, which is conducive to further standardizing the order of the medical device industry and effectively protecting the legitimate rights and interests of consumers and the safety of
equipment.

 

7.
The case of using unregistered medical devices in Huian New Huixing Geriatric Hospital

 

Brief Facts of the Case

 

Following the clues from the higher-level authorities, the Market Supervision Administration of Huian County, Quanzhou City, Fujian Province, conducted on-site inspections
of Huian Xinhuixing Geriatric Hospital three times on December 3, 2021, December 8, 2021 and January 6, 2022.
After investigation, the gastrointestinal endoscopy system used by the parties to identify a certain brand was purchased on December 4, 2020 for medical devices that had been used abroad, with a value of 202,490 yuan and a total of 43,600 yuan in illegal
gains.
The parties' failure to strictly implement the purchase inspection record system, the failure to implement the pre-use quality inspection system for medical devices and the use of unregistered medical devices violated the first paragraph of Article 45 and Article 55 of the Regulations on the Supervision and Administration of Medical Devices (State Council Order No.
739) and Article 13
of the Measures for the Supervision and Administration of the Quality of Medical Devices 。 In accordance with Item 3 of the first paragraph of Article 86 and Item 3 of the first paragraph of Article 89 of the Regulations on the Supervision and Administration of Medical Devices (Order No.
739 of the State Council), and Item 5 of the first paragraph of Article 30 of the Measures for the Supervision and Administration of the Quality of the Use of Medical Devices, the Huian County Market Supervision Administration ordered the parties concerned to correct the illegal conduct, imposed a warning, confiscated the products involved in the case and illegal gains of 43,600 yuan, and fined 3,239,840 yuan
.

 

Typical significance

 

In order to ensure the safety and effectiveness of medical devices and protect human health and life safety, the state implements a product registration system
for Class II and III medical devices.
The parties in this case attempted to cover up their illegal acts
of using the medical devices involved in the case by concealing the medical devices involved in the case, providing false statements and explanations, and providing false contracts.
Law enforcement personnel obtained medical insurance reimbursement records from the medical insurance department, traced the source of the medical devices involved in the case from the manufacturer, and sought technical support from the customs anti-smuggling department, and verified the illegal facts
of the parties.
Since the illegal use of the parties continued until December 2021, they were subject to supervision and inspection, and the case-handling department applied the Regulations on the Supervision and Administration of Medical Devices (State Council Order No.
739),
which came into effect on June 1, 2021.
The investigation and handling of this case has effectively dealt a blow to the illegal perpetrators of medical devices who have the mentality of trying to cover up the facts and evade legal responsibility, and demonstrated the firm determination
of the regulatory authorities to implement the "four strictest" requirements for drug safety, crack down on illegal business activities in the field of medical devices and ensure the safety of the people's use of equipment.

 

8.
Hami Dengke Glasses Sales Co.
, Ltd.
operated Class III medical devices without permission

 

Brief Facts of the Case

 

On January 13, 2022, the Market Supervision Administration of Yizhou District, Hami City, Xinjiang, inspected
Hami Dengke Glasses Sales Co.
, Ltd.
After investigation, the parties were suspected of engaging in the business activities of Class III medical devices such as contact lenses and contact lens lubricants without permission, and the value of the goods involved was 58,800 yuan
.
The conduct of the parties engaged in Class III medical device business activities without permission violated the first
paragraph of Article 42 of the Regulations on the Supervision and Administration of Medical Devices (State Council Order No.
739).
。 On April 29, 2022, the Yizhou District Market Supervision Administration of Hami City, in accordance with Item 3, Paragraph 1 of Article 81 of the Regulations on the Supervision and Administration of Medical Devices (State Council Order No.
739) and the Provisions on the Application of the Discretionary Power of Administrative Penalties of the Xinjiang Uygur Autonomous Region Drug Administration (for Trial Implementation), decided to give the parties a mitigated punishment and imposed administrative penalties
of confiscating the illegal operation of contact lenses and contact lens lubricants, confiscating illegal gains, and fining 88,000 yuan.

 

Typical significance

 

Color contact lenses belong to corneal contact lenses, which are specified as Class III medical devices in China's medical device classification catalog, with high risk, are fitting medical devices with special business conditions, and have a strict fitting process
.
Article 42 of the Regulations on the Supervision and Administration of Medical Devices stipulates that if a person engages in the business of Class III medical devices, the business enterprise shall apply for a business license
from the department responsible for drug supervision and administration of the people's government at the districted-city level where it is located.
Engaging in colored contact lens business activities without permission cannot guarantee the safety of products, disrupts the order of market operation, and brings risks
to consumers' health.
The State Food and Drug Administration is organizing a nationwide special rectification action to standardize the production and operation of color contact lenses, focusing on strengthening the investigation and handling of illegal acts such as the production and operation of unregistered color contact lenses, unauthorized production and business activities, and illegal online sales, so as to ensure the safety of
public equipment.
Consumers are reminded to choose merchants with relevant qualifications when purchasing colored contact lenses and care solutions
.

 

9.
"3.
10" Guangxi Hezhou production and sale of counterfeit cosmetics

 

Brief Facts of the Case

 

In December 2021, the Market Supervision Administration of Hezhou City, Guangxi Zhuang Autonomous Region, received reports from the public that there were black dens
for the manufacture and sale of cosmetics in Jingtou Village, Lianshan Town, Buchuan Yao Autonomous County.
The Hezhou Municipal Administration for Market Supervision immediately organized an investigation, and on the basis of the clues in the early stage, organized law enforcement personnel and public security organs to carry out a concentrated operation in March 2022, destroyed 6 black dens for the production of cosmetics without a license in one fell swoop, and seized a large number of counterfeit cosmetics, production raw materials and production equipment
on the spot.
According to the Regulations on the Supervision and Administration of Cosmetics, the Hezhou Municipal Administration for Market Supervision determined that the above-mentioned illegal acts were suspected of constituting a crime, and organized the Buchuan Yao Autonomous County Market Supervision Administration to transfer the case to the public security organ in accordance with the law, and continued to investigate it together with the public security organ
.
So far, the public security organs have arrested 51 criminal suspects, and the Buchuan County People's Procuratorate has approved the arrest of 6 major criminal suspects and transferred 5 people
for review and prosecution.
The case is under further investigation
.

 

Typical significance

 

In recent years, the demand for cosmetics market has been increasing
day by day.
In order to make huge profits, some criminals use black dens to produce cosmetics, and usually produce counterfeit domestic and foreign best-selling brand cosmetics
.
According to Article 27 of the Regulations on the Supervision and Administration of Cosmetics, cosmetics production activities shall obtain a cosmetics production license
.
Such black dens do not meet the requirements of the cosmetics production quality management practice on cosmetics production personnel, sites, facilities and equipment, etc.
, there are greater risks to product quality and safety, and this behavior infringes the legitimate rights and interests of the relevant brand cosmetics production and
operation enterprises.
In this case, in order to evade supervision, criminals hid in remote areas at the intersection of provincial borders to produce counterfeit cosmetics
.
The drug regulatory department gave full play to its professional and technical advantages, worked closely with the public security organs, insisted on tracing the root cause of illegal products, and finally eliminated the source of unlicensed production, effectively safeguarding the safety
of public cosmetics.

 

10.
Guangzhou Gude Cosmetics Co.
, Ltd.
produced cosmetics with illegal addition of substances that may endanger human health

 

Brief Facts of the Case

 

In September 2021, the Guangdong Provincial Drug Administration discovered during its daily supervision and inspection that Guangzhou Gude Cosmetics Co.
, Ltd.
was suspected of using raw materials with illegally added pharmaceutical ingredients to produce cosmetics, and immediately organized risk control measures for the products and raw materials involved in the case, and opened a case for investigation
of the enterprise.
After investigation, between April and August 2021, three batches of cosmetics such as rice tea and rice repair milk commissioned by the company were all detected to contain the pharmaceutical ingredient Benvimod
.
The production of cosmetics that may endanger human health by the enterprise falls under the circumstances
stipulated in Article 59, Paragraph 3 of the Regulations on the Supervision and Administration of Cosmetics.
In view of the fact that the products involved in the case involved children's cosmetics, the circumstances of the violation were serious, and the punishment should be strictly in accordance with the provisions of the Regulations on the Supervision and Administration of Cosmetics
.
In August 2022, the Guangdong Provincial Drug Administration imposed an administrative penalty on the enterprise for confiscating illegally produced cosmetics, confiscating illegal gains, fining 120,000 yuan, revoking the cosmetics production license, and not handling the filing of cosmetics submitted by the company or accepting the application for cosmetics administrative license for 10 years; Li Jianyuan, the legal representative of the enterprise, was fined 108,000 yuan and banned from engaging in cosmetics production and business activities for life
.

 

Typical significance

 

Benvimod is a class of innovative prescription drugs
approved by the State Food and Drug Administration in 2019 for the treatment of psoriasis.
According to the drug insert, this vimod should not be used in patients under 18 years of age, not on the patient's head and face, perioral and eyelids, and the total clinical medication time should not exceed 12 weeks
.
The common adverse reactions of this drug are mainly itching and dermatitis at the drug site
.
Adding this vimod to cosmetics for daily skin care is a serious violation of adding substances that may endanger human health to cosmetics, and shall be severely punished
in accordance with the provisions of the Regulations on the Supervision and Administration of Cosmetics.
Although the amount involved in this case was not large, the drug regulatory authorities resolutely implemented the "four strictest" requirements of the Party Central Committee and the State Council on drug safety, and gave the enterprises involved in the case the revocation of cosmetics production licenses in accordance with the law, and gave the legal representatives of the enterprises involved in the case lifelong bans from business, effectively deterring lawbreakers
.