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Medical Network News, March 18, throughout the year inspected 544 drug manufacturers, issued 488 notices of ordering corrections; resolved 4,756 illegal cases of drug equipment; took the lead in exploring the establishment of a "discipline and punishment" connection mechanism for drug law enforcement in the country.
.
.
17 The Hunan Provincial Drug Regulatory Work Conference held in Changsha on Japan revealed that the province strictly controls drug safety risks and takes many measures to strengthen and enhance regulatory capabilities
.
In the process of supervision and inspection, the Hunan Provincial Drug Administration has scientifically and rationally divided the supervision tasks according to the risk level of the subject of supervision and the supervision power of the provinces and cities, effectively breaking through the bottleneck of the weak supervision power, and building accurate inspections of the provinces and bureaus, assisted inspections by the cities and states, and enterprises.
The subject's self-inspection of the "three-in-one" drug risk prevention and control system has explored a new way of supervision with Hunan characteristics and drug supervision characteristics
.
According to reports, Hunan has sorted out all documents related to drug supervision since 2005, reviewed and abolished 550, retained 216, and revised 33, formulated 7 legal supervision systems, including case review committees and administrative response, and improved the power operation system.
Norms
.
In recent years, the Key Laboratory of Pharmaceutical Excipient Engineering Technology Research has successfully applied for the key laboratory of the State Administration, and the Hunan Pharmaceutical Quality Evaluation Engineering Technology Research Center has successfully passed the acceptance.
16 provincial and municipal inspection institutions in the province have participated in 79 drug proficiency testing programs.
The level of inspection and testing is improving year by year
.
Streamlining administration, delegating power, combining decentralization, and optimizing services are major trends in current reforms
.
Hunan vigorously promotes the reform of "commitment system licensing", and on the basis of the implementation of the "commitment is renewal" trial of drug production, wholesale, retail chain headquarters and medical device production license renewal, further expand the scope of the commitment system licensing pilot, and develop medical institutions Renewal of preparation permits, alteration of permits for pharmaceutical wholesale companies and retail chain headquarters, and extension of the validity period of cosmetics production permits
.
The province has also vigorously promoted the consistency evaluation of generic drugs, and clearly rewarded 5 million yuan for each of the first products in the country that passed the evaluation, which greatly mobilized the enthusiasm of corporate drug research
.
Liang Yiheng, Secretary of the Party Leadership Group of the Hunan Provincial Drug Administration, introduced that this year, the bureau will focus on the supervision of new coronavirus vaccines, further increase vaccine quality and safety supervision, and strictly check purchase channels, distribution flows, cold chain management, and information traceability.
; At the same time, focus on special rectification of rural drug safety, especially in key areas such as township health centers, retail pharmacies, and individual clinics, to ensure that no regional systemic risks occur; in addition, it will guide and integrate social resources to increase investment in technological innovation and improve The province's pharmaceuticals, medical devices, and cosmetics supervision of practical technology and methods research, promote the transformation and application of research results, and further enhance the competitiveness of Hunan's biomedical industry
.
"It is necessary to effectively implement the main responsibilities of enterprises, the territorial responsibilities of local governments, the regulatory responsibilities of regulatory agencies and the inspection responsibilities of inspection agencies, strengthen the supervision of the entire process of drug production, operation, and use, and firmly promote daily inspections and various special rectifications, and resolutely adhere to The bottom line of no major quality and safety accidents
.
" Xiang Shuguang, secretary of the Party group and director of the Hunan Provincial Market Supervision Administration, said that it is necessary to promote regulatory innovation and use various methods such as market, administration, law, technology, and social participation to establish a sound scientific and efficient , Authoritative drug regulatory system, strengthen the construction of professional and specialized drug inspectors, and enhance drug regulatory capabilities
.
(Finish)
.
.
17 The Hunan Provincial Drug Regulatory Work Conference held in Changsha on Japan revealed that the province strictly controls drug safety risks and takes many measures to strengthen and enhance regulatory capabilities
.
In the process of supervision and inspection, the Hunan Provincial Drug Administration has scientifically and rationally divided the supervision tasks according to the risk level of the subject of supervision and the supervision power of the provinces and cities, effectively breaking through the bottleneck of the weak supervision power, and building accurate inspections of the provinces and bureaus, assisted inspections by the cities and states, and enterprises.
The subject's self-inspection of the "three-in-one" drug risk prevention and control system has explored a new way of supervision with Hunan characteristics and drug supervision characteristics
.
According to reports, Hunan has sorted out all documents related to drug supervision since 2005, reviewed and abolished 550, retained 216, and revised 33, formulated 7 legal supervision systems, including case review committees and administrative response, and improved the power operation system.
Norms
.
In recent years, the Key Laboratory of Pharmaceutical Excipient Engineering Technology Research has successfully applied for the key laboratory of the State Administration, and the Hunan Pharmaceutical Quality Evaluation Engineering Technology Research Center has successfully passed the acceptance.
16 provincial and municipal inspection institutions in the province have participated in 79 drug proficiency testing programs.
The level of inspection and testing is improving year by year
.
Streamlining administration, delegating power, combining decentralization, and optimizing services are major trends in current reforms
.
Hunan vigorously promotes the reform of "commitment system licensing", and on the basis of the implementation of the "commitment is renewal" trial of drug production, wholesale, retail chain headquarters and medical device production license renewal, further expand the scope of the commitment system licensing pilot, and develop medical institutions Renewal of preparation permits, alteration of permits for pharmaceutical wholesale companies and retail chain headquarters, and extension of the validity period of cosmetics production permits
.
The province has also vigorously promoted the consistency evaluation of generic drugs, and clearly rewarded 5 million yuan for each of the first products in the country that passed the evaluation, which greatly mobilized the enthusiasm of corporate drug research
.
Liang Yiheng, Secretary of the Party Leadership Group of the Hunan Provincial Drug Administration, introduced that this year, the bureau will focus on the supervision of new coronavirus vaccines, further increase vaccine quality and safety supervision, and strictly check purchase channels, distribution flows, cold chain management, and information traceability.
; At the same time, focus on special rectification of rural drug safety, especially in key areas such as township health centers, retail pharmacies, and individual clinics, to ensure that no regional systemic risks occur; in addition, it will guide and integrate social resources to increase investment in technological innovation and improve The province's pharmaceuticals, medical devices, and cosmetics supervision of practical technology and methods research, promote the transformation and application of research results, and further enhance the competitiveness of Hunan's biomedical industry
.
"It is necessary to effectively implement the main responsibilities of enterprises, the territorial responsibilities of local governments, the regulatory responsibilities of regulatory agencies and the inspection responsibilities of inspection agencies, strengthen the supervision of the entire process of drug production, operation, and use, and firmly promote daily inspections and various special rectifications, and resolutely adhere to The bottom line of no major quality and safety accidents
.
" Xiang Shuguang, secretary of the Party group and director of the Hunan Provincial Market Supervision Administration, said that it is necessary to promote regulatory innovation and use various methods such as market, administration, law, technology, and social participation to establish a sound scientific and efficient , Authoritative drug regulatory system, strengthen the construction of professional and specialized drug inspectors, and enhance drug regulatory capabilities
.
(Finish)
