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Improving the eight major systems   Promoting the implementation of the "Implementation Opinions" to come into effect

Time:2021-12-16 Views:332

Medical Network News on August 6: A few days ago, the General Office of the State Council issued the "Implementation Opinions on Comprehensively Strengthening the Capacity Building of Drug Supervision" (hereinafter referred to as the "Implementation Opinions"). The "Implementation Opinions" is a policy document issued by the General Office of the State Council specifically for drug regulatory capacity building. It reflects the great importance of the Party Central Committee and the State Council on drug regulatory work, and is significant and far-reaching for the establishment of a scientific, efficient and authoritative drug regulatory system. Meaning. Jiangxi Provincial Drug Administration organized all party members and cadres to earnestly study the "Implementation Opinions", and in accordance with the ideas of strengthening the foundation, making up for shortcomings, breaking bottlenecks, and promoting improvement, jointly formulated and issued the "14th Five-Year Plan" Drugs in Jiangxi Province in conjunction with the Jiangxi Provincial Development and Reform Commission In the process of "Safety and High-quality Development Plan", it is proposed to improve the "eight systems", accelerate the establishment of a scientific, efficient, and authoritative drug regulatory system, and promote the implementation of the "Implementation Opinions" to come into effect.


The first is to improve the policy coordination system for promoting the high-quality development of the biopharmaceutical industry chain. Encourage the innovation and development of the biopharmaceutical industry, promote the introduction of more measures to accelerate the development of the biopharmaceutical industry by relevant departments, and further improve the regulatory policies, medical insurance policies, and industrial development policies. Synergy promotes the higher-quality development of the biomedical industry chain. Continue to promote the reform of the drug review and approval system, and encourage the innovative development of drugs. Initiated the compilation of the quality standards of Jiangxi traditional Chinese medicine formula granules, revised the "Jiangxi Province Traditional Chinese Medicine Preparation Standards", promoted the industrial development of the province's classic famous prescriptions, and promoted the Jiangxi traditional Chinese medicine industry to continue to maintain the forefront of the country. Actively connect with the Yangtze River Delta region and the Guangdong-Hong Kong-Macao Greater Bay Area, and introduce supporting policies for the development of key industrial parks to promote the improvement of the energy level of the biomedical industry cluster.


The second is to improve the drug regulatory system that conforms to the laws of the big market. Promote the establishment of a provincial drug safety coordination agency, coordinate the promotion of drug safety and the high-quality development of the industry, strengthen the performance evaluation of local governments in fulfilling drug safety responsibilities, and promote the implementation of drug safety. responsibility. Strengthen the medical supervision and management professional force of the city and county market supervision departments to ensure that they have the professional supervision team and conditions that are compatible with the supervision power. Formulate guidance on the division of powers for drug supervision, strengthen the supervision and coordination of drug supervision agencies at the provincial, municipal, and county levels in the whole life cycle of drugs, and gradually build the provincial drug regulatory bureau as the center and the dispatched agency as the extension, and the city and county supervision The drug safety supervision network that is efficiently connected by the departments has formed a chess pattern of drug supervision work in the whole province. Improve the inspection and case handling mechanism, strengthen the construction of drug inspection teams at the provincial, city, and county levels, and form a mechanism for drug law enforcement to link up and down the province and quickly respond.


The third is to improve the professional talent team system that meets the regulatory requirements of the new era. In accordance with the principle of "improving the existing, supplementing the deficiencies, optimizing the structure, and making good reserves", accelerate the construction of a professional and professional inspector team, and strive to build a full-time inspection team. The staff is the main body and the part-time inspectors are supplemented by a team of politically strong, high-quality, skilled, clean and efficient drug inspectors. Establish a hierarchical and classified management system for inspectors. Broaden the career development space of inspectors, improve the review policy of inspectors' titles, improve and improve the salary and benefits distribution mechanism, and establish an inspector discipline and supervision mechanism. Promote the implementation of the professional quality improvement project of the supervision team, and carry out the professional ability training of reviewers at all levels, inspection and testing personnel, and supervision and law enforcement personnel in an orderly manner, and strive to basically realize the professionalization of the province's drug supervision team by the end of the "14th Five-Year Plan". Speed up the introduction of high-level talents and provide talent guarantee and intellectual support for drug supervision.


  Fourth is to improve the risk prevention and control system that adapts to the modern needs of governance capabilities. Strengthen the comprehensive research and judgment of drug quality and safety risks, form a risk list, and clarify the focus of supervision. Improve the risk classification supervision and evaluation standards of production enterprises, and establish a dynamic adjustment mechanism for supervision levels. Strengthen the supervision of high-risk products such as vaccines, blood products, implantable medical devices, and special cosmetics. Establish an Internet transaction supervision and monitoring system, improve the online and offline coordinated supervision mechanism, and severely crack down on illegal activities such as the production and sale of counterfeit drugs and illegal addition of cosmetics. Establish a unified pharmacovigilance system, give full play to the advantages of sentinel points, strengthen active monitoring, identify various risks, and realize the prevention and control of quality and safety risks throughout the life cycle.


Fifth, improve the drug safety technical support system that adapts to the high-quality development of the industry  Integrate technical resources such as technical review, on-site verification, inspection and testing, adverse reaction monitoring, standard management, etc., to form a provincial drug regulatory agency as the main body and cities and counties as the supplement A scientific and efficient review work system with matching powers and capabilities. Accelerate the construction of the biological product batch issuing laboratory of Jiangxi Provincial Institute of Drug Inspection and Testing, and the key laboratory of quality evaluation of Chinese patent medicines of the State Food and Drug Administration, so as to achieve full coverage of inspection and testing capabilities for biological products, chemicals, traditional Chinese medicines and pharmaceutical packaging materials. High-quality completion of the inspection and testing capacity building project of Jiangxi Medical Device Testing Center to meet the development needs of the medical device industry. Improve cosmetic inspection capabilities, accelerate the construction of inspection and safety evaluation laboratories for banned and restricted substances in cosmetics, and make up for shortcomings in inspection and inspection capabilities. Strengthen the business guidance of provincial-level inspection and testing agencies to city and county-level inspection and testing agencies, and carry out capacity building.


The sixth is to improve the smart drug regulatory system that adapts to the application of big data  Focusing on the core tasks of "big system, big data, and big platform" proposed by the National Medical Products Administration, applying big data, cloud computing, artificial intelligence and blockchain and other technical means, Form an integrated supervision platform based on business systems such as licensing approval, daily supervision, remote supervision, random inspection, law enforcement, credit management, public services, etc., to achieve the "all-round, full-link, and full-process" smart supervision goal of the pharmaceutical industry. Improve the "one company, one file" and data center construction, promote the digitalization and networking of review and approval and license management, promote the interconnection, sharing and sharing of supervisory business systems at all levels and units, and gradually realize the "one network connection" and "cross-provincial connection" ". Implement the "smart pharmacy" construction project and build an online and offline integrated "smart pharmacy" service platform to make it more convenient, faster and more satisfying for consumers to purchase drugs. Complete the construction of the traceability supervision system for drugs, medical devices, and Chinese herbal medicines, and play the role of traceability data in risk prevention and control, product recall, and emergency response. Adhere to the network management network, promote the construction of a network monitoring system, and improve the ability to supervise online transactions of drugs, medical devices and cosmetics.


   Seven is to improve the drug safety emergency system that adapts to the handling of public health emergencies   improve the emergency response plans for drug safety incidents of the people's governments at all levels, and improve the emergency management mechanism. Summarize the experience in the prevention and control of the new crown pneumonia epidemic, and strengthen the unified command and coordination of inspection and testing, system verification, review and approval, and monitoring and evaluation in response to major public health incidents. Establish an early warning mechanism for public opinion information, carry out risk exchanges and consultations, and respond to social concerns in a timely manner. Strengthen the construction of provincial drug safety emergency drill centers, strengthen the training and actual combat drills for major public health emergencies and other emergency response capabilities, promote the normalization of drug emergency drills, and improve the emergency response capabilities of drug regulatory agencies in the province.


   Eight is to improve the social co-governance system that adapts to the new pattern of comprehensive governance   promote regulatory scientific research, and build the Jiangxi Province Traditional Chinese Medicine Regulatory Science, Drug Regulatory Policy, and Cosmetics Regulatory Scientific Research Center. Actively carry out the publicity of drug science knowledge to improve the public's drug safety awareness and risk prevention capabilities. Give full play to the role of industry associations, promote industry integrity and self-discipline, and guide and urge enterprises to carry out production and operation activities in accordance with the law.


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