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On April 12, the National Drug Regulatory Policies and Regulations Work Conference was held in Beijing in the form of video
.
The meeting was guided by Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, thoroughly studied and implemented the spirit of the 19th National Congress of the Communist Party of China and the 19th Plenary Sessions, implemented the spirit of the Central Economic Work Conference, and followed the deployment requirements of the National Drug Supervision and Administration and Party Style and Clean Government Work Conference.
, summarize the work in 2021, analyze the current situation, and study and deploy the work tasks in 2022
.
Xu Jinghe, member of the party group and deputy director of the State Food and Drug Administration, attended the meeting and delivered a speech
.
The meeting fully affirmed the achievements of drug regulatory policies and regulations since 2021
.
The first is to speed up the improvement of the drug regulatory system
.
The "Regulations on the Supervision and Administration of Cosmetics" and the new "Regulations on the Supervision and Administration of Medical Devices" were promulgated and implemented, and relevant core supporting regulations were issued in an orderly manner
.
Research and establish an emergency use system for medicines and medical devices to fully serve the overall situation of epidemic prevention and control
.
Comprehensively standardize legislative work procedures and effectively improve the quality and level of legislative work
.
The second is to focus on promoting the implementation of major policies
.
The "Implementation Opinions of the General Office of the State Council on Comprehensively Strengthening the Construction of Drug Regulatory Capacity" has been promoted effectively and effectively
.
Fully absorb the opinions and suggestions of the grassroots, revise and improve the assessment indicators, and further implement the requirements for reducing the burden of assessment
.
Strengthen the standardized management of policy research topics, and strengthen the promotion and application of results
.
The third is to continue to deepen the reform of "delegating power, regulating services"
.
Solidly promote the compilation of the list of powers and responsibilities, and revise and improve the list of administrative licenses
.
Intensify the reform of "separation of licenses and licenses", and continue to optimize the business environment under the rule of law
.
The fourth is to standardize and enhance the ability and level of administrative law enforcement
.
Promote the promulgation of the "two high" judicial interpretations, and carry out demonstration and revision of the work method for the connection between drug execution and punishment
.
The investigation and handling of cases were intensified, and the number of administrative penalty cases increased substantially
.
Give full play to the supervisory role of reconsideration and response to lawsuits, and make supervision and law enforcement more strict, standardized, impartial and civilized
.
Fifth, make every effort to promote the construction of a national vaccine supervision system
.
Successfully completed the WHO remote mid-term assessment, internal audit and management review of the vaccine regulatory quality management system
.
The sixth is to carry out in-depth publicity work on the rule of law
.
The "Eighth Five-Year" law popularization plan for the drug administration system was issued
.
Compiled and published the "Reading Book of Drug Administration Law and Vaccine Administration Law"
.
Seven units passed the acceptance inspection and became the first batch of "pharmaceutical legal publicity and education bases" to enhance the influence of legal publicity on drug safety
.
The meeting emphasized that Xi Jinping's thought on the rule of law provides a fundamental basis for the rule of law work in drug supervision in the new development stage, and General Secretary Xi Jinping's series of important instructions have pointed out the direction for the realization of long-term drug safety, optimizing the legal business environment in the field of drugs and reforming the cause of drug supervision.
Innovation has put forward higher requirements, and comprehensively strengthening the drug supervision system and capacity building has laid a solid foundation for effectively improving the legalization of drug supervision
.
It is necessary to deeply study and understand, and unremittingly arm the mind with Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, guide practice, and promote the rule of law in drug safety
.
It is necessary to adhere to the right direction, adhere to the feelings of the people, improve the rule of law system, solve outstanding problems, improve the quality of the rule of law, and effectively implement Xi Jinping's thought on the rule of law in the whole process of the construction of the rule of law in drug supervision
.
It is necessary to adhere to overall planning and coordination, strengthen cross-level, cross-regional and cross-departmental joint law enforcement, and strengthen the timely transfer of criminal clues
.
It is necessary to adhere to the linkage between construction and construction, and to carry out in-depth special rectification combined with improving the supervision system and establishing a sound long-term mechanism
.
It is necessary to strengthen the deterrent force of supervision, so as to make clear rules in the front, strict control in the middle, and severe punishment in the back, through perfecting open and transparent supervision rules, strictly standardizing, impartial and civilized law enforcement, severely cracking down on illegal and criminal behavior, and creating a better environment business environment
.
It is necessary to further improve the political position, further unify thoughts and actions into the decision-making and deployment of the Party Central Committee and the State Council, and go all out to ensure that the requirements of the supervision system and supervision capacity building are implemented and effective
.
The meeting made arrangements for the key work in 2022
.
First, we must continue to make efforts to accelerate the improvement of the legal system
.
We will make every effort to promote the revision of regulations such as the Implementation Regulations of the Drug Administration Law, speed up the formulation and revision of supporting rules and regulations, and continue to strengthen the legal guarantee system for epidemic prevention and control
.
Second, we must highlight key points and continue to strengthen the construction of law enforcement supervision systems
.
Strengthen the publicity and implementation of the "two high" judicial interpretations, actively promote the improvement of the working mechanism for the connection of executions, continuously increase the supervision of case investigation and handling, and give full play to the role of administrative reconsideration litigation and law enforcement supervision
.
The third is to strengthen the implementation of the list, and promote the continuous deepening of the reform of "delegating power, regulating services"
.
Focus on the announcement and implementation of the list of powers and responsibilities, accelerate the implementation of the list of administrative licenses, and actively carry out research on the reform of "decentralization, management and services"
.
Fourth, we must serve the overall situation and do a good job in the research of major regulatory policies
.
Accelerate the implementation of major policies and achieve results, and continuously strengthen the management of policy research topics
.
Better play the role of the assessment baton
.
Fifth, we must be close to reality and carry out in-depth publicity and education on the rule of law on drugs
.
We will implement the "Eighth Five-Year" law popularization plan, carry out in-depth publicity and implementation of the drug regulatory system, and continue to promote the construction of legal publicity and education positions
.
Sixth, we must move steadily and further promote the construction of the vaccine quality management system
.
Benchmarking with international standards, continue to improve the ability and level of vaccine supervision
.
At the meeting, the main responsible comrades and relevant responsible comrades of the five provincial (city) drug administrations in Beijing, Hebei, Jiangsu, Shandong and Chongqing exchanged speeches on policy research, standardized management of administrative filings, standardized law enforcement, local legislation, and law popularization.
.
Relevant persons in charge of various departments, bureaus and directly affiliated units of the State Food and Drug Administration attended the meeting in the main venue, and the persons in charge of the Food and Drug Administration of the provinces (autonomous regions and municipalities) and Xinjiang Production and Construction Corps, the persons in charge of the Law and Regulations Department and relevant personnel participated in the video at the branch venues meeting
.
The heads of the China Drug Regulatory Research Association and the first batch of drug law publicity and education bases attended the meeting
.
.
The meeting was guided by Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, thoroughly studied and implemented the spirit of the 19th National Congress of the Communist Party of China and the 19th Plenary Sessions, implemented the spirit of the Central Economic Work Conference, and followed the deployment requirements of the National Drug Supervision and Administration and Party Style and Clean Government Work Conference.
, summarize the work in 2021, analyze the current situation, and study and deploy the work tasks in 2022
.
Xu Jinghe, member of the party group and deputy director of the State Food and Drug Administration, attended the meeting and delivered a speech
.
The meeting fully affirmed the achievements of drug regulatory policies and regulations since 2021
.
The first is to speed up the improvement of the drug regulatory system
.
The "Regulations on the Supervision and Administration of Cosmetics" and the new "Regulations on the Supervision and Administration of Medical Devices" were promulgated and implemented, and relevant core supporting regulations were issued in an orderly manner
.
Research and establish an emergency use system for medicines and medical devices to fully serve the overall situation of epidemic prevention and control
.
Comprehensively standardize legislative work procedures and effectively improve the quality and level of legislative work
.
The second is to focus on promoting the implementation of major policies
.
The "Implementation Opinions of the General Office of the State Council on Comprehensively Strengthening the Construction of Drug Regulatory Capacity" has been promoted effectively and effectively
.
Fully absorb the opinions and suggestions of the grassroots, revise and improve the assessment indicators, and further implement the requirements for reducing the burden of assessment
.
Strengthen the standardized management of policy research topics, and strengthen the promotion and application of results
.
The third is to continue to deepen the reform of "delegating power, regulating services"
.
Solidly promote the compilation of the list of powers and responsibilities, and revise and improve the list of administrative licenses
.
Intensify the reform of "separation of licenses and licenses", and continue to optimize the business environment under the rule of law
.
The fourth is to standardize and enhance the ability and level of administrative law enforcement
.
Promote the promulgation of the "two high" judicial interpretations, and carry out demonstration and revision of the work method for the connection between drug execution and punishment
.
The investigation and handling of cases were intensified, and the number of administrative penalty cases increased substantially
.
Give full play to the supervisory role of reconsideration and response to lawsuits, and make supervision and law enforcement more strict, standardized, impartial and civilized
.
Fifth, make every effort to promote the construction of a national vaccine supervision system
.
Successfully completed the WHO remote mid-term assessment, internal audit and management review of the vaccine regulatory quality management system
.
The sixth is to carry out in-depth publicity work on the rule of law
.
The "Eighth Five-Year" law popularization plan for the drug administration system was issued
.
Compiled and published the "Reading Book of Drug Administration Law and Vaccine Administration Law"
.
Seven units passed the acceptance inspection and became the first batch of "pharmaceutical legal publicity and education bases" to enhance the influence of legal publicity on drug safety
.
The meeting emphasized that Xi Jinping's thought on the rule of law provides a fundamental basis for the rule of law work in drug supervision in the new development stage, and General Secretary Xi Jinping's series of important instructions have pointed out the direction for the realization of long-term drug safety, optimizing the legal business environment in the field of drugs and reforming the cause of drug supervision.
Innovation has put forward higher requirements, and comprehensively strengthening the drug supervision system and capacity building has laid a solid foundation for effectively improving the legalization of drug supervision
.
It is necessary to deeply study and understand, and unremittingly arm the mind with Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, guide practice, and promote the rule of law in drug safety
.
It is necessary to adhere to the right direction, adhere to the feelings of the people, improve the rule of law system, solve outstanding problems, improve the quality of the rule of law, and effectively implement Xi Jinping's thought on the rule of law in the whole process of the construction of the rule of law in drug supervision
.
It is necessary to adhere to overall planning and coordination, strengthen cross-level, cross-regional and cross-departmental joint law enforcement, and strengthen the timely transfer of criminal clues
.
It is necessary to adhere to the linkage between construction and construction, and to carry out in-depth special rectification combined with improving the supervision system and establishing a sound long-term mechanism
.
It is necessary to strengthen the deterrent force of supervision, so as to make clear rules in the front, strict control in the middle, and severe punishment in the back, through perfecting open and transparent supervision rules, strictly standardizing, impartial and civilized law enforcement, severely cracking down on illegal and criminal behavior, and creating a better environment business environment
.
It is necessary to further improve the political position, further unify thoughts and actions into the decision-making and deployment of the Party Central Committee and the State Council, and go all out to ensure that the requirements of the supervision system and supervision capacity building are implemented and effective
.
The meeting made arrangements for the key work in 2022
.
First, we must continue to make efforts to accelerate the improvement of the legal system
.
We will make every effort to promote the revision of regulations such as the Implementation Regulations of the Drug Administration Law, speed up the formulation and revision of supporting rules and regulations, and continue to strengthen the legal guarantee system for epidemic prevention and control
.
Second, we must highlight key points and continue to strengthen the construction of law enforcement supervision systems
.
Strengthen the publicity and implementation of the "two high" judicial interpretations, actively promote the improvement of the working mechanism for the connection of executions, continuously increase the supervision of case investigation and handling, and give full play to the role of administrative reconsideration litigation and law enforcement supervision
.
The third is to strengthen the implementation of the list, and promote the continuous deepening of the reform of "delegating power, regulating services"
.
Focus on the announcement and implementation of the list of powers and responsibilities, accelerate the implementation of the list of administrative licenses, and actively carry out research on the reform of "decentralization, management and services"
.
Fourth, we must serve the overall situation and do a good job in the research of major regulatory policies
.
Accelerate the implementation of major policies and achieve results, and continuously strengthen the management of policy research topics
.
Better play the role of the assessment baton
.
Fifth, we must be close to reality and carry out in-depth publicity and education on the rule of law on drugs
.
We will implement the "Eighth Five-Year" law popularization plan, carry out in-depth publicity and implementation of the drug regulatory system, and continue to promote the construction of legal publicity and education positions
.
Sixth, we must move steadily and further promote the construction of the vaccine quality management system
.
Benchmarking with international standards, continue to improve the ability and level of vaccine supervision
.
At the meeting, the main responsible comrades and relevant responsible comrades of the five provincial (city) drug administrations in Beijing, Hebei, Jiangsu, Shandong and Chongqing exchanged speeches on policy research, standardized management of administrative filings, standardized law enforcement, local legislation, and law popularization.
.
Relevant persons in charge of various departments, bureaus and directly affiliated units of the State Food and Drug Administration attended the meeting in the main venue, and the persons in charge of the Food and Drug Administration of the provinces (autonomous regions and municipalities) and Xinjiang Production and Construction Corps, the persons in charge of the Law and Regulations Department and relevant personnel participated in the video at the branch venues meeting
.
The heads of the China Drug Regulatory Research Association and the first batch of drug law publicity and education bases attended the meeting
.