In 2021, the investigation and handling of drug cases in my country will continue to increase

 

In 2021, drug regulatory authorities will conscientiously implement General Secretary Xi Jinping's "four strictest" requirements for drug safety, adhere to risk management, whole-process control, scientific supervision, and social co-governance, and continue to strengthen the protection of high-risk products in the "two products and one device" field.
Supervision, continuously increase the investigation and resolution of potential risks and crack down on illegal and criminal behaviors, and effectively protect the health rights and interests of the people
.

 

Case investigations continue to intensify

 

In 2021, drug regulatory authorities at all levels will further strengthen law enforcement and case handling
.
In terms of the number of cases, more than 130,000 cases of "two products and one weapon" were investigated and handled throughout the year, an increase of 27% over 2020
.
Among them, more than 100,000 cases originated from daily supervision and special inspections, an increase of more than 30% compared with 2020; more than 10,000 cases originated from supervision sampling inspections and law enforcement inspections, an increase of nearly 28% compared with 2020
.
In terms of the value of the goods, the value of the goods investigated and handled in the whole year exceeded 1.
9 billion yuan, the amount of fines exceeded 1.
6 billion yuan, and the illegal gains of nearly 200 million yuan were confiscated, an increase of 44%, 36% and 12% respectively compared with 2020; ordered to suspend production and business.
There are more than 500 enterprises, and about 60 licenses have been revoked; constantly strengthen coordination and cooperation with public security organs and other departments, strengthen the connection between execution and discipline, strictly implement the requirements for punishment of illegal acts, and severely investigate and deal with a number of major cases and transfer them to judicial organs There were nearly 700 cases, and China's first lifetime ban on cosmetics was issued, which severely punished violations of laws and regulations and ensured the overall stability of the drug
safety situation .

 

　　Supervision of high-risk key products continues to be strengthened

 

　　In 2021, drug regulatory authorities at all levels will adhere to the bottom-line thinking, further strengthen the supervision of high-risk key products, and comprehensively strengthen the quality supervision of medical devices for epidemic prevention and control
.
Strengthen the supervision of the production and operation of new coronavirus vaccines, improve the quality and efficiency of batch issuance, and issue more than 5 billion doses of new coronavirus vaccines throughout the year
.
All new coronavirus vaccines are incorporated into the information traceability system to realize the traceability of the whole process
.
Strengthen the supervision and inspection of all aspects of vaccines, realize full coverage of vaccine production enterprises, distribution enterprises, disease control institutions and inoculation units, urge enterprises to implement their main responsibilities, and strictly prevent illegal outflow and illegal trafficking; achieve 100% of the national "centralized procurement" of selected pharmaceutical equipment enterprises.
% full coverage inspection and 100% full coverage sampling inspection of selected varieties
.
Include innovative drugs, medical devices , new drug marketing license holders, and medical device registrants into the focus of supervision, and conduct inspections on blood product manufacturers
.
Supervise and inspect high-risk products such as special drugs, sterile and implantable medical devices, and special cosmetics in an orderly manner
.
Carry out a special inspection campaign for children's cosmetics "protecting seedlings", and resolutely protect the safety of children's makeup
.

 

　　The effect of quality supervision in the whole life cycle continues to improve

 

　　In 2021, drug regulatory authorities at all levels will coordinate the use of unannounced inspections, supervision and random inspections, and handling of complaints and reports to timely study and judge new situations and problems, and take effective measures to investigate and resolve the hidden dangers of "two products and one machine", so that supervision runs on risks.
front
.
Intensified on-site inspections, inspected 4.
21 million drug, medical device, and cosmetic companies (users), and completed 190,000 rectifications
.
Intensified sampling inspection, completed 210,000 batches of drugs, with a pass rate of 99%; completed nearly 30,000 batches of medical device varieties, with a pass rate of 95%; completed national sampling of cosmetics in more than 20,000 batches, with a pass rate of 98% %; products and enterprises that fail to pass the random inspection shall be investigated and punished according to law
.
Strengthen risk monitoring, improve the monitoring platform for online sales of drugs and medical devices, carry out special rectification actions for online sales of violations of laws and regulations, establish a "through train" inspection system for high-risk information on cosmetics, and collect and deal with high-risk signals in a timely manner
.
A closed-loop risk supervision over the whole life cycle of "two products and one machine" has basically been formed, and no systematic or regional major quality and safety risks have occurred
.

 

　　In 2021, drug regulatory authorities will conscientiously implement General Secretary Xi Jinping's "four strictest" requirements for drug safety, adhere to risk management, whole-process control, scientific supervision, and social co-governance, and continue to strengthen the protection of high-risk products in the "two products and one device" field.
Supervision, continuously increase the investigation and resolution of potential risks and crack down on illegal and criminal behaviors, and effectively protect the health rights and interests of the people
.

 

　　Case investigations continue to intensify

 

　　In 2021, drug regulatory authorities at all levels will further strengthen law enforcement and case handling
.
In terms of the number of cases, more than 130,000 cases of "two products and one weapon" were investigated and handled throughout the year, an increase of 27% over 2020
.
Among them, more than 100,000 cases originated from daily supervision and special inspections, an increase of more than 30% compared with 2020; more than 10,000 cases originated from supervision sampling inspections and law enforcement inspections, an increase of nearly 28% compared with 2020
.
In terms of the value of the goods, the value of the goods investigated and handled in the whole year exceeded 1.
9 billion yuan, the amount of fines exceeded 1.
6 billion yuan, and the illegal gains of nearly 200 million yuan were confiscated, an increase of 44%, 36% and 12% respectively compared with 2020; ordered to suspend production and business.
There are more than 500 enterprises, and about 60 licenses have been revoked; constantly strengthen coordination and cooperation with public security organs and other departments, strengthen the connection between execution and discipline, strictly implement the requirements for punishment of illegal acts, and severely investigate and deal with a number of major cases and transfer them to judicial organs There were nearly 700 cases, and China's first lifetime ban on cosmetics was issued, which severely punished violations of laws and regulations and ensured the overall stability of the drug
safety situation .

 

　　Supervision of high-risk key products continues to be strengthened

 

　　In 2021, drug regulatory authorities at all levels will adhere to the bottom-line thinking, further strengthen the supervision of high-risk key products, and comprehensively strengthen the quality supervision of medical devices for epidemic prevention and control
.
Strengthen the supervision of the production and operation of new coronavirus vaccines, improve the quality and efficiency of batch issuance, and issue more than 5 billion doses of new coronavirus vaccines throughout the year
.
All new coronavirus vaccines are incorporated into the information traceability system to realize the traceability of the whole process
.
Strengthen the supervision and inspection of all aspects of vaccines, realize full coverage of vaccine production enterprises, distribution enterprises, disease control institutions and inoculation units, urge enterprises to implement their main responsibilities, and strictly prevent illegal outflow and illegal trafficking; achieve 100% of the national "centralized procurement" of selected pharmaceutical equipment enterprises.
% full coverage inspection and 100% full coverage sampling inspection of selected varieties
.
Include innovative drugs, medical devices , new drug marketing license holders, and medical device registrants into the focus of supervision, and conduct inspections on blood product manufacturers
.
Supervise and inspect high-risk products such as special drugs, sterile and implantable medical devices, and special cosmetics in an orderly manner
.
Carry out a special inspection campaign for children's cosmetics "protecting seedlings", and resolutely protect the safety of children's makeup
.

 

　　The effect of quality supervision in the whole life cycle continues to improve

 

　　In 2021, drug regulatory authorities at all levels will coordinate the use of unannounced inspections, supervision and random inspections, and handling of complaints and reports to timely study and judge new situations and problems, and take effective measures to investigate and resolve the hidden dangers of "two products and one machine", so that supervision runs on risks.
front
.
Intensified on-site inspections, inspected 4.
21 million drug, medical device, and cosmetic companies (users), and completed 190,000 rectifications
.
Intensified sampling inspection, completed 210,000 batches of drugs, with a pass rate of 99%; completed nearly 30,000 batches of medical device varieties, with a pass rate of 95%; completed national sampling of cosmetics in more than 20,000 batches, with a pass rate of 98% %; products and enterprises that fail to pass the random inspection shall be investigated and punished according to law
.
Strengthen risk monitoring, improve the monitoring platform for online sales of drugs and medical devices, carry out special rectification actions for online sales of violations of laws and regulations, establish a "through train" inspection system for high-risk information on cosmetics, and collect and deal with high-risk signals in a timely manner
.
A closed-loop risk supervision over the whole life cycle of "two products and one machine" has basically been formed, and no systematic or regional major quality and safety risks have occurred
.