Medical network - February 22 February 21, the Chinese government net released "" much starker choices-and graver consequences-in" national drug safety planning ", the following is the full text:
"Much starker choices-and graver consequences-in" national drug safety planning
To ensure the safety of medicines is the important content of building health China, enhance people's well-being, is the embodiment of people's development thought for the center. In order to improve the quality and safety of drugs, according to the law of the People's Republic of China on the 13th five-year plan for national economic and social development program, formulate the plans.
A, the present situation and the situation
"Twelfth five-year" period, in the joint efforts of all aspects, stable positive drug safety situation in our country, the people use secure, positive progress in drug safety work.
(a) a further satisfy the public demand. Policies in a timely manner, and priority review part of examination and approval for urgent clinical needs of generic drugs, to speed up the review of the examination and approval of major disease, a rare disease, the elderly and children's disease have better curative effect of innovative drugs and medical devices. A group in the treatment of cancer, AIDS, rare diseases, children's hand, foot and mouth disease, polio, and other fields with independent intellectual property rights of innovative medicine, as well as domestic biological materials, high-end image products, such as heart stents medical device to market, meet the demand of the masses.
(2) review of the examination and approval system reform made solid progress. Medicines under the state council on reform of medical equipment review system of examination and approval opinions "(guo fa [2015] 44) requirements, promote the quality of generic drugs and curative effect evaluation, consistency in 10 provinces (municipalities) to carry out the marketing authorisation holder system pilot, improve clinical trials for examination and approval, improve the quality of review for examination and approval, public review approval information, promote the establishment of scientific and efficient review of examination and approval system.
(3) regulations, perfecting standard system. Announced revised regulations on the supervision and administration of medical devices and drug production quality management standard, drug management quality management standard, etc. Improve pharmaceutical medical equipment standards, drugs and revising standard 4368 standard 130, medical equipment, medicine packaging material 566. Make announce the law of the People's Republic of China pharmacopoeia (2015 edition) ".
(4) the whole process of supervision system basic formation. Pharmaceutical non-clinical research and the quality control standard for pharmaceutical medical equipment quality control standard for clinical trials, medicine, medical equipment production and the quality control standard, medicine, medical equipment management and the quality control standard for steady implementation, from the lab to the hospital the whole process of supervision system basically in place, covering all varieties, the whole chain of drug tracing system is established.
(5) violation behavior severely hit. A food and drug administrative law enforcement and criminal justice cohesion way to work. False registration filing, violations of the masses feel strongly about the production, the illegal business, exaggerated propaganda, the use of unlicensed products and producing JiaLie violation behavior, such as drug sustained special blow. To investigate and punish drug administrative cases, 750000 cases of medical devices, the public security organs to detect harmful drug safety case of more than 46000 cases. To declare manufactured or imported drug registration application, overall clinical trial data and check list for verification.
(6) support ability strengthened steadily. Financial support at all levels continue to increase, the regulatory ability get promoted. Perfect drug review of medical equipment, inspection and testing system, the establishment of our state adverse drug reaction monitoring system. An increasing number of licensed pharmacists.
The author affirms the achievements, which must be awake to recognize that some deep-seated problems affecting the safety of drug quality in our country still exists, drug quality security situation is still grim. Overall level of drug quality, part of the product quality effect there is a gap with the international advanced level, some urgent clinical needs products is difficult to meet the actual demand of public medicine, almost three-quarters of drug approval number. Licensed pharmacists medical service role play does not reach the designated position, unreasonable drug problems. Drug regulatory infrastructure is still relatively weak, unified authority regulatory system has not yet been established, inadequate regulatory professionals, basic equipment is equipped with the lack of regulatory capacity is not fully used to with the healthy development of the medicine industry requirements.
"Much starker choices-and graver consequences-in" period is the decisive stage to build a well-off society in an all-round way, and establish strict efficiency and comprehensive system of social work of drug safety management in the key period. To respect the law of drug safety, and continue to increase the intensity of work, adhere to the drug safety as political task to carry out the relationship between the people's livelihood, and ensure that the people safety.
Second, the general requirements
(a) the guiding ideology.
Comprehensively implement the party's 18 large and 18 sixth plenary session of 3, 4, 5, spirit, with marxism-leninism, MAO zedong thought, deng xiaoping theory and "three represents" important thought, the concept of scientific development as guidance, in-depth implementation of xi jinping, general secretary of the series of important speech spirit, earnestly implement the CPC central committee and the state council decision deployment, closely around as a whole to promote "five one" the overall layout and coordination to promote "comprehensive" four strategic layout, firmly set up and implement the innovation, the coordination, the development of the green, open, sharing ideas, adhere to the most rigorous standards, strict regulation, the most severe punishment, the most serious accountability, to speed up the modernization management system built and drug safety, improve the level of scientific supervision, encourage research and innovation, improve quality, increase effective supply, ensure drug safety for the people, promote our country by big pharmaceutical pharmaceutical powers, China construction promote health.
(2) the basic principles.
1. The maintenance of public health, safeguard public demand. Adhere to people's health as the center, the development strategy of priority to people's health status, and ensure the public safety, effective, and, to prevent drug safety incidents, to safeguard people's health and life security.
2. We will deepen reform of the review of the examination and approval and enhance the level of supervision. Continue to deepen reform of "pipes" and regulation in service, optimize procedures, streamline processes, open and transparent, improve the scientific and regulatory mechanism, enhance supervision efficiency and level.
3. To encourage innovation, improve product quality. To solve clinical problems as the guidance, to carry out the innovation driven development strategy, aimed at the international advanced level, breaking restraints on the development of innovative ideas and institutional barriers, promote innovation level, promote the enterprises to strengthen quality and safety control, to improve drug quality and curative effect.
4. Strengthen the regulation of the whole, to ensure that the drug is safe and effective. To improve the oversight system for unified authority, promoting drug administration under the rule of law, standardization, specialization, informationization, improve the technical support ability, strengthen the whole process of supervision, the whole life cycle, ensure drug safety, efficacy and quality controllable at or near the international advanced level.
(3) the development goals.
By 2020, the quality and safety of drugs, drug safety control ability, the pharmaceutical industry development level and people's satisfaction improved significantly.
1. Drug quality further improved. Approval of new drugs in order to solve clinical problems as the guidance, has obvious curative effect; Approval of generic drugs in accordance with the original drug quality and curative effect. For drugs already on the market by quality and consistency evaluation of curative effect. Finished before the end of 2018, the national list of essential medicines (2012 edition) approved before October 1, 2007 of the 289 chemicals of oral solid preparation of generics consistency evaluation; Encourage enterprises to evaluate other listed varieties for consistency.
2. Drugs medical devices standards. Complete and revising the national drug standard medical devices and 3050 3050.
3. Review the examination and approval system gradually improve. Drug review of medical equipment examination and approval system more perfect, more clear responsibilities, process more smooth, notably enhanced, according to the prescribed time limit for examination and approval of the review.
4. Check the ability to further improve. Relying on existing resources, make professional inspectors can meet the needs of check the quantity, quality, increase the inspection frequency.
5. Monitoring and evaluation level to further improve. Adverse drug reactions and medical device adverse event reporting system and the enterprise as the main body of perfecting evaluation system, monitoring and evaluation ability has reached the international advanced level, the drugs security updates on a regular basis to evaluate rate of 100%.
6. The examination and supervision law enforcement capabilities to be enhanced. Medicine medical device testing institutions corresponding construction meet the national standards. Implement all supervisory team equipped with standardized.
7. The licensed pharmacists service level increased significantly. Licensed pharmacists per million population of more than 4 people, all retail pharmacies main managers qualified licensed pharmacists, the business has licensed pharmacists to guide rational drug use.
Three, the main task
(a) accelerate the generic quality and consistency evaluation of curative effect.
Pharmaceutical production enterprise is the main body of consistency evaluation work, by the relevant guidelines should be active reference preparation of choose and buy, reasonable selection of evaluation methods, to carry out research and evaluation. Food and drug regulatory authorities to strengthen the guidance of pharmaceutical production enterprise consistency evaluation, formulate relevant guidelines, timely information published reference preparations, gradually establish the generic reference preparation directory set.
Refinement implement health care payments, clinical application, the drug centralized purchasing, the enterprise technical renovation and other aspects of support policy, effectively solve the clinical trial resources shortage, encourage enterprises to carry out the consistency evaluation work. Over varieties through consistency evaluation after the other drug manufacturing enterprises of the same variety consistency in principle should be completed within three years. Perfect consistency evaluation mechanism and enrich the professional technical force, strict standard, the standard procedures, review of the enterprise on time submit the consistency of the evaluation and drug registration application.
(2) we will deepen reform of the drug review of medical equipment examination and approval system.
1. Encourage innovation. Complete drug marketing authorisation holder system pilot, timely sum up experience, improve the system, strive to fully implemented as soon as possible. Encourage has clinical value for urgent clinical needs by new drugs and generic drugs research and development of the listed, has significant clinical value of innovative drugs and AIDS, malignant tumors, the major infectious diseases, diseases such as rare diseases clinical need drugs, a priority review for approval. For innovative drug clinical trial application, key review clinical value and content for the protection of the subjects, clinical trials to speed up the approval. Clinical institutions and encourage doctors to participate in the innovation medicine and medical equipment research and development. With product core technology invention patents, has significant clinical value of innovative medical devices, and included in the national key research and development, science and technology major projects for urgent clinical needs of medicine medical apparatus and instruments, a priority review for approval. Develop and regularly publish restricted and encouraged catalogue of drug approval, timely public registration information, guide enterprises to reduce unreasonable to declare.
2. Perfect for examination and approval of the review mechanism. The review of the quality control system. Establish medical devices with a core of clinical drug review mechanism, perfect the indications on the assessment team, project managers, technical dispute resolution, communication, priority review, review of public information system, gradually formed with technical evaluation as the core, on-site inspection and product inspection drugs to support medical curative effect and security system. To establish and perfect the system of drug data protection, and encourage innovation.
3. Strict review approval requirements. Improving drug approval standards, innovative medicine clinical value, improve type new drug reflect superiority, generic drugs to in line with the original drug quality and curative effect.
4. The reform of medical device classification management. Improve the committee and the professional medical device classification, the risk assessment mechanism and establish medical devices category dynamic updating mechanism. For medical device nomenclature are guidelines, and gradually implement according to the general name of medical equipment. Set the encoding rules of medical equipment, medical equipment coding system.
Column 1 review of examination and approval system reform
(a) generic quality consistency and curative effect evaluation.
Related technology required to produce or transformation consistency evaluation guidelines and guiding principles, the consistency evaluation capacity building, according to the work needs, relying on existing resources, with a certain number of specialized personnel.
(2) solve the backlog of drug registration.
According to the requirements of the state council, an application for registration as soon as possible and annual review quantity in and out of balance, according to the prescribed time limit for examination and approval.
(3) we will accelerate reform of the medical device classification management.
Formation of 16 professional classification technology, optimizing adjustment category framework and structure, release a new version of the catalog of medical device classification, according to the field to develop guidelines for 22 nomenclature are set research, establishing database of medical device classification, naming and coding.
(3) improve the laws and regulations standard system.
1. Improve the system of laws and regulations. Push the revised drug administration law. Revision of cosmetic health supervision regulations. Basically complete system of medicine, medical equipment, cosmetics supporting regulations revision. System revision according to the drug safety situation, laws and regulations, clear rules and normative documents, and build scientific and complete system of drug safety laws and regulations.
2. Perfect the technical standard. Contrast to the international advanced level establishment the law of the People's Republic of China pharmacopoeia (2020 edition), chemical pharmaceutical standards reached the international advanced level, biological products standard is close to the international advanced level, the traditional Chinese medicine (material) standards in the international leading position. Raising the overall level of pharmaceutical excipients, medicine packaging standards, expand coverage for varieties, steadily improve the national medicine (material) standards. Elimination mechanism, establishing pharmaceutical standards fully clean up the calendar contains not breed standard edition pharmacopoeia and all kinds of office (department) technique standard, a batch of ascension, an unspecified number of. To speed up the medical instrument research into international standard, the priority to improve medical instrument based standards of the general and high-risk products. Cosmetics and revising relevant standards.
3. The perfect technical guidelines. Revised drug non-clinical research, and non-prescription drug clinical trials, classification, pharmaceutical excipients safety evaluation, drug registration management, technical review medical device registration, such as guiding principle, revised drug production, management and the quality control standard for the appendix and technical guidance. Develop medical equipment use and adverse event monitoring technology guide the production and business operation.
Column 2 standards improve action plan
(a) drug standards improve action plan.
And revising the national drug standard 3050, including traditional Chinese medicine (TCM) national drug standard of 1100, chemicals standard 150, 1500 and biological pharmaceutical excipients standard 200, medicine packaging standard 100.
The drug registration and revising technical guidelines 350. Pharmacopoeia records and revising the testing method, the general principles of the (general) as well as technical guidelines 100. According to the need to promptly formulate released a batch of drugs added inspection method.
Development of traditional Chinese medicine (TCM) ethnic medicine and natural medicine standard substances, including chemical reference substance extracts from 200, against 150 kinds of herbs and control, 100. Developed pharmaceutical excipients and medicine packaging standard substances, including pharmaceutical excipients 150 kinds of reference substance, drug packaging material 10.
(2) medical devices standards improve action plan.
Medical apparatus and instruments and revising standard 500 items, including diagnostic reagents class standards, 80 active medical devices standards, passive medical equipment and other 200 standard 220 items.
Medical equipment technical review and clinical trials and revising guidelines 200. Development of in vitro diagnostic reagent 150 kinds of standard substances.
Establish and improve the standardization of medical equipment management system, relying on existing resources, strengthening the construction of national medical instrument standard management center, with satisfy need standard management personnel.
(3) the cosmetic standards improve action plan.
Cosmetics disabled, limited by material testing and revising methods 30-50 items.
(4) strengthen the supervision of the whole process.
1. Strictly regulate the development and production management using behavior.
Strengthen the regulation of development link. Full implementation of pharmaceutical non-clinical research and the quality control standard for pharmaceutical clinical test and the quality control standard, medical equipment quality control standard for clinical trials. Relying on existing resources, the establishment of clinical trial data management platform, to strengthen supervision and inspection of the clinical trials, a crackdown on clinical data to fraud, to ensure the clinical trial data are true and correct.
Strengthen the supervision of production process. Full implementation of the pharmaceutical production quality management standard, Chinese herbal medicine production quality management standard and Chinese medicine yinpian processing, medical equipment production quality management. For pharmaceutical raw materials and drug packaging materials production enterprises to carry out supervision. For vaccines, blood products and other biological products and blood screening diagnosis reagent therelease of full implementation of the management. Strengthen the supervision of sterile and implantable medical devices production. Improve the system of enterprise production process change report, the significant changes of productive technology for review in accordance with the examination and approval. Investigate drug production cut corners, doping ShiJia, unauthorised changes to the process of production of substandard medicines violation behavior, etc.
Strengthen the regulation of circulation. Full implementation of the pharmaceutical management quality management, medical equipment management quality management, to improve the quality of cold chain transport storage regulation. Production management enterprise procurement business people online registration and verification system. In accordance with the requirements for "much starker choices-and graver consequences-in" deepen reform, promote drug purchase "two votes", encourage pharmaceutical producing enterprises and medical institutions to settle payment directly.
Strengthen the supervision of use link. Strictly implement the measures for the management of medical institutions and drug, using quality supervision measures for the administration of medical devices, strictly the purchase, acceptance, storage, maintenance, deployment and use of each link quality, timely report adverse drug reactions and adverse events of medical equipment. Strict implementation of regulations on prescription sales prescription drugs, strengthen the management of narcotic drugs, psychotropic drugs prescription. Strengthen the management of using such high-risk medical planted instruments.
Establish the whole lifecycle management system. Establish the archives. Full implementation of drugs, medical devices vigilance and post-marketing study enterprise's main body responsibility, production enterprises to carry out the risk factors of listed products analysis and risk evaluation, to form the product quality analysis report in time and before the end of January every year submitted to the food and drug supervision administration. Strengthen the listed again after evaluation, according to the evaluation results, to the patient and the doctor of security information, organization change label instructions in a timely manner. Out long-term production, clinical value is small, no better alternative varieties of products, and the curative effect is not exact, big security risk, benefit no longer outweigh the risks.
2. Strengthen the on-site inspection and comprehensive supervision to sample. , in accordance with the principle of "double random, a public" strengthen the regulation of things after the event. Focus around the norms, process compliance, reliable data, etc., to check quality management all the projects, to crack down on fraud and other kinds of illegal behavior, urge the enterprise strict quality management standard. Increase register check, check and outside check flight frequency, to improve inspection ability. More to sterile, implantable medical devices and inspections of in vitro diagnostic reagents. Compliance checks of cosmetics raw material usage. Reasonable division of proper national and local varieties and project, intensify to sample to high-risk varieties, expand the sample coverage.
(3) intensify law enforcement case and information disclosure. To strengthen the construction of national auditing law enforcement team ability, organize and coordinate major cases investigation, to strengthen the guidance and supervision, to explore the inspection audit and work mechanism, set up the national unified, authoritative and efficient audit law enforcement system. To strengthen the public security organs at all levels to crack down on drug crime of professional construction, strengthen the security handling the case. Deepen the administrative law enforcement and criminal justice cohesion, push for drug violation penalties to the person's legal measures, increase the crackdown on illegal and criminal behavior. Accelerate the construction of complaint reporting system, clear complaint reporting channels, encourage social supervision. In accordance with the provisions, comprehensive public administrative licensing, daily supervision, sampling inspection, inspection audit, law enforcement and punishment information.
Column 3 safety regulatory action plan
(a) strengthen the drug inspection.
National annual check pharmaceutical production enterprise in 300-400, a year full coverage checking blood products and vaccine production enterprises. About 40-60 varieties of imported drugs every year to carry out overseas production site inspection.
(2) to strengthen the medical equipment examination.
Every year to all national class iii medical device manufacturing enterprise and the second category of sterile medical device manufacturing enterprise for a whole project inspection. Since 2018, every two years for the rest of the second category of medical device manufacturing enterprise and all the first kind of medical device manufacturing enterprise for a whole project inspection. Every year about 30-40 overseas medical device manufacturing enterprise quality management system to carry out the inspection, during the period of "much starker choices-and graver consequences-in" realizing a complete coverage of the high-risk medical equipment products to be imported. Complete coverage of annual inspection have special request for storage and transportation enterprise, "much starker choices-and graver consequences-in" during implementation of sterile, implantable medical devices and in vitro diagnostic reagents enterprise full coverage checking. Every year for the whole check third rate medical equipment usage of medical institutions, "much starker choices-and graver consequences-in" during the implementation of a complete coverage of other units to use check.
(3) strengthen the cosmetic inspection.
National annual check 20 cosmetics production enterprises, the provincial annual check 30 cosmetics production enterprise.
(4) strengthen the supervision to sample.
Every year to 120-140 national high-risk drugs to carry out the supervision to sample, production enterprises within their respective administrative areas at provincial level production complete coverage of the basic drugs for sample.
Every year to 40-60 kinds of national medical devices to carry out the supervision to sample.
Every year in 15000 batches of cosmetics supervision to sample and risk monitoring 1000 batches of cosmetics.
4. To strengthen the emergency disposal and popular science propaganda. Establish and improve the emergency management system, strengthen the emergency response plan management, carry out emergency drills and skills training, improve enterprise emergency disposal plan scheme. To strengthen the public opinion surveillance, properly handle emergency. Strengthening public opinion guidance, in accordance with the provisions, release drug safety information, timely response to social concerns. Support the news media in the supervision of public opinion, objective and fair coverage drug safety. Establishment of national, provincial, municipal and county level 4 popular science propaganda work system, building three-dimensional platform news propaganda, and increase the intensity of popular science propaganda, raise the safety science.
Column 4 emergency disposal and popular science propaganda promotion project
(a) emergency capability construction.
Reasonable security response team takes office needs, strengthen emergency information platforms, emergency information for network, emergency inspection detection capability.
(2) the three-dimensional popular science propaganda plan.
Implement drug safety science popularization projects, relying on existing resources to strengthen the construction of demonstration base, propaganda station and science knowledge base, enrich the propaganda strength, promote "two micro end" new media platform, in-depth to carry out "national drug safety month" activities.
(5) strengthening capacity building.
1. Strengthen the ability construction of technical evaluation. To strengthen the construction of the review scientific basis, review of perfect quality management system, establish the electronic declaration and review process management system. Explore the reform of government purchase service mechanism, performance salary allocation management.
2. To strengthen the inspection system construction. Improve inspection ability, the standard to carry out the drugs, medical devices, cosmetic inspection.
(3) strengthening the examination system.
Strengthen national, provincial, city level 3 drug inspection detection system ability construction, strengthen the national, provincial two levels of medical device testing institutions and city sub-center ability construction. National inspection agency has a strong scientific research, technological innovation, arbitration inspection and the re-inspection ability; Provincial inspection agency to complete the corresponding legal inspection, supervision, inspection and law enforcement inspection, emergency task, have a certain scientific research ability, can carry out basic and crucial test measure technology and rapid and complementary test detection method research; Municipal inspection institution to complete routine supervision and law enforcement inspection tasks; Inspection agency at the county level has the capability of rapid test. To strengthen the examination information construction. Encourage universities and colleges, enterprises inspection institutions to undertake the government inspection tasks.
To strengthen the construction of key laboratories and port inspection agency. Key laboratory in the relevant field research ability, has the domestic first-class inspection level and port drug inspection institutions with the legal standard based on the test of all items and monitoring the quality of imported drugs risk ability.
Strengthen the system and the examination therelease of vaccines and other biological products capacity building. National biological products standards and reference materials preparation ability, can according to the legal standard for all item test of biological products, At the provincial level to the legal standard based on biological products manufactured by enterprises within their respective administrative areas tested for all items. To strengthen the construction of national microbiology standard material library and vaccine testing technology research and development.
4. To strengthen the monitoring and evaluation system. Improve the adverse drug reactions and medical device adverse event monitoring mechanism, drug abuse monitoring mechanism, establish monitoring sentinel key product monitoring and early warning. Innovative means of monitoring and evaluation, expand coverage for monitoring. To urge enterprises to carry out the monitoring subject.
Column 5 technical support capacity building project
(a) construction of state-level review center.
Explore innovative drug review of medical equipment management system and corporate governance institutions. Reform business unit of choose and employ persons mechanism, establish a reasonable mechanism of incentive and constraint, and scientific research institutes, joint training of medical review of hospital personnel. Consummate the drug approval medical device review database.
(2) check capacity building.
Reasonable security check work needs, to ensure a complete pharmaceutical medical equipment daily check, certified check, flight check, the ability to check.
Security review, examination, monitoring and evaluation at all levels and other technical support by the business.
(3) the examination ability construction.
1. The inspection standards ability testing project.
Standards for the construction of drugs medical equipment inspection detection according to the standard construction of medicine medical device testing institutions at all levels. Relying on the construction of food and drug verification research institute of China national pharmaceutical medical device testing institutions. Upgrade and port drug inspection institutions at the provincial level, provincial medical equipment inspection organizations. Relying on existing resources, construction of a group of drugs, medical devices and cosmetics regulatory key laboratory.
2. The vaccine therelease of system construction.
To perfect China's food and drug verification research institute as the core, the provincial institutions to participate in the national therelease of vaccine vaccine therelease of system. Relying on existing resources, resource repository establishment conforms to the international standard cells, stem cells, bacteria (drug) library, set up perfect biological material research and supply platform, quality evaluation standard and technology platforms.
(4) adverse reactions and adverse events monitoring capacity building.
Relying on existing resources, construction of national adverse drug reaction monitoring system (phase ii) and the national cosmetics adverse reaction monitoring system. Using the electronic data of medical institutions, the establishment of pharmaceutical medical equipment safety initiative monitoring and evaluation system. Set up the 300 adverse drug reactions in general hospital and medical device adverse event monitoring sentinel. In mental disease specialist hospital and general hospital set up 100 drug abuse monitoring sentinel. County (city, area) report adverse drug reaction ratio above 90%. Focus on monitoring of 100 medical equipment products. Medical device adverse events county (city, area) report more than 80%. Cosmetics adverse reactions report of 50 / one million.
5. Form wisdom regulation ability. The top design and overall planning, strengthen the surrounding medicine medical equipment cosmetics administrative examination and approval, supervision inspection, the inspection of law enforcement, emergency management, inspection monitoring, risk analysis, credit management, public service and other key business, implement safety supervision information engineering, promoting safety regulation big data resource sharing and application of increase the efficiency of the regulation.
Column 6 safety information engineering
Continue to push forward the regulatory information construction, relying on the national unification and existing e-government network resources, the construction of national, provincial two levels of drug safety regulation large data centers, and drug safety supervision information platform, improve drug regulatory information standard system, drug regulatory information resource management system, government affairs information system, network security system, information service performance evaluation system, the construction of connected together, meet the demand of regulation of administrative examination and approval, supervision inspection, the inspection of law enforcement, emergency management, inspection monitoring, risk analysis, credit management, public service application system.
6. Improve basic regulatory support capability. Regulation at various levels have business premises, law enforcement vehicles equipped with standardized construction, law enforcement equipment, meet the on-site inspection, supervision and law enforcement, field sampling, rapid testing, emergency disposal needs.
Column 7 basic regulatory capacity standardization construction projects
Regulators and strengthen the city, county towns (street) the dispatched office of law enforcement and the basic equipment, forensic equipment, rapid test equipment and infrastructure construction.
7. To strengthen the science and technology support. Appropriate technology for research, service for regulatory and industry development. Drug safety basis, quality control, safety evaluation and early warning, the examination technology, standard and quality improvement research, strengthen drug purity and so on technical support. Relying on existing resources to set up a batch of drug safety research base, develop drug safety technology talents.
Column 8 pharmaceutical medical equipment safety technology support task
(a) drug inspection test key technology research.
To carry out the drug fast inspection of new technology and equipment, emergency method, supplementary examination methods of research. Strengthen the key techniques of drug research and development production and quality control.
(2) drug safety, efficacy evaluation technology research.
To develop new type of biological products, chemicals, toxic Chinese medicinal materials, vaccines, new drugs and special drug dosage forms, such as security, effectiveness evaluation technology research, strengthen the drug packaging materials and pharmaceutical excipients safety evaluation research.
(3) the examination research platform, database construction, etc.
Establishing TCM injections, Chinese herbal medicine examination database and polysaccharide drugs and multicomponent biochemical medicine quality control technology platform, develop drug safety big data analysis research.
(4) the key techniques of medical device testing.
Carry out all kinds of digital products, medical equipment, individualized diagnosis and treatment of biomedical materials quality evaluation and testing technology research and testing specification, strengthen medical apparatus and instruments commonly used fast inspection system, high-risk medical instrument testing platform. Carried out in medical device field test method, test platform and equipment research.
(5) safety evaluation system and research of medical equipment.
Strengthen the medical equipment safety evaluation technology and standard system research, system to carry out safety studies, such as high risk medical planted instruments to carry out medical robot, medical material manufacturing innovative medical devices standards system research.
8. We will accelerate the establishment of a professional inspector team. Relying on existing resources to establish a system for professional inspector, the inspector's responsibility clear, condition demands, training management, performance appraisal, etc. Strengthen inspector professional training and teaching material construction. In such aspects as personnel management, performance salary allocation to take a variety of incentives, encourage talents to regulate flow.
Column 9 professional quality promotion project
(a) professional inspector team construction.
Strengthen training examination, make professional inspectors conform to the requirements of the corresponding work.
(2) the cultivation of talents.
Promoting the construction of network education training platform. In the provincial education training institutions to establish professional teaching bases.
Regulators specialized training time not less than 40 hours per year per person. New staff standardized training time not less than 90 hours. To classification, head of the local governments at all levels in charge of the training. National DiaoXun on the relevant person in charge of regulatory agencies at all levels.
Bachelor degree or above personnel to reach 70% of the total drug safety supervision team, high-level professionals accounted for more than 15% of the technical team. Drug safety front line supervisors, drug related professional background of the people accounted for 2% increase every year.
(3) the licensed pharmacists team construction.
A sound system of licensed pharmacists system. To establish the management information system of licensed pharmacists. Implementation of licensed pharmacists ability and engineering degree in ascension, strengthen the continuing education and training.
Fourth, safeguard measures
(a) strengthen policy guarantee.
Adhere to the department coordination, the whole chain, will be to ensure the safety of drugs and the further reform and improve better use policy as a whole, for producing and distributing medicines by deepening reform, to break systems and mechanisms affecting the safety of drug quality problems. With further promote drug review of medical equipment examination and approval system reform, to develop detailed drug price, bidding and purchasing, payment, science and technology support and so on supporting policies, establish and improve the incentive mechanism, to urge enterprises actively improve the quality of the product. Improve the shortage of drug supply security and early warning mechanism, to ensure clinical dosage of necessary, uncertainty of cheap drugs, rescue medication and rare diseases medicine market supply. Set up the mechanism of drug price information traceability, establish a unified price information platform across departments, prepare and drug centralized purchasing platform (public resources trading platform), health care payment platform connectivity. To encourage pharmaceutical production circulation enterprise merger and reorganization, bigger and stronger. Enterprise credit record and practitioners should be brought into the national credit information sharing platform, joint punishment of dishonest ACTS. To establish drug medical equipment product liability insurance and damages compensation mechanism.
(2) the reasonable security funds.
According to the state council on promoting the central and local fiscal instructional advice on the reform of the governance and expenditure responsibility "(guo fa [2016] no. 49) requirements, reasonably determine the central and local governments at all levels of protection of the funds for drug regulatory responsibilities. Continue to arrange the infrastructure investment of drug safety regulation of infrastructure and equipment to actively support and funding to the grassroots, concentrated destitute areas, national poverty alleviation and development work as well as the key counterpart support areas such as the appropriate tilt. Review project promote drug medical device registration trial reform of the government purchasing service. The plan (project, work) involved in technology research and development related content, is really necessary, the central financial support by the national science and technology plan (special, funds, etc.) as a whole to consider support.
(3) to deepen international cooperation.
Promote government regulation between exchanges, strengthen multilateral cooperation, actively join the relevant international organizations. International project cooperation, build private international communication platform. Increase the intensity of training and foreign intelligence importation. Active participation in international standards and rules, promote our country supervision idea, method and standard coordinated with the international advanced level.
(4) strengthen organization and leadership.
The development of the local governments at various levels should be determined in accordance with the planning objectives and major tasks, drug safety work should be brought into the important agenda and the region's economic and social development plans. A comprehensive law enforcement place to enrich regulatory power at the grass-roots level, the food and drug safety supervision as the primary responsibility. All departments concerned should, according to the division of responsibilities, refine the goal, task decomposition, formulate specific implementation plan. The food and drug supervision administration led by mid-term assessment and the implementation of this plan a midterm examination, to ensure all tasks in place. |
