After the founding of New China, the medical security system in China was gradually established and developed. Due to various reasons, China's medical security system is divided between urban and rural areas, each with different characteristics and development process. In cities and towns, it has gone through the stages of public expense and labor insurance medical system, the pilot stage of urban medical insurance reform, the establishment stage of the national basic medical insurance system for urban workers and the exploration stage of multi-level medical security system. In rural areas, with the rise and fall of the cooperative medical system, efforts should be made to build a new rural cooperative medical system, and then explore and improve the diversified rural medical security system. The Third Plenary Session of the Eleventh Central Committee established the theme of reform and opening up. In the process of transition from planned economy to market economy, the institutional background of China's medical security began to change greatly, and the traditional medical security system gradually lost its own foundation. The reform of urban basic medical security system is closely related to the reform of financial system, medical system, the establishment of modern enterprise system and the change of ownership structure. With the reform in various related fields of reform and opening up, the reform of medical security system is a natural thing. The medical system of public expense and labor insurance mainly appeared before the reform and opening up, so I won't explain it too much here.

(1) Phase I (1978~ 1998): medical security reform pilot. Since the early 1980s, some enterprises and localities have spontaneously explored ways to reform the traditional medical security system for employees, such as reimbursement of fixed medical expenses or overspending, and linking medical expenses with personal interests. The continuous development of these reform practices has also laid a certain psychological foundation for employees to bear medical expenses, showing a change from a publicly funded medical system to a moderately self-funded system.

In order to further solve the increasingly prominent problems in the field of medical security, on April 28th, 1984, the Ministry of Health and the Ministry of Finance jointly issued the Notice on Further Strengthening the Management of Public Medical Care, proposing to actively and steadily reform the public medical care system, and starting a new stage for the government to explore and reform the traditional public medical care system.

Local governments take the lead in the practice of medical system reform, and the main way is to control costs through social overall planning. For example, Shijiazhuang, Hebei Province has launched a pilot project of social co-ordination of medical expenses for retirees in six counties and cities since June 1985+0 1; In May, 1987, Beijing Dongcheng District Vegetable Company launched "serious illness medical co-ordination", which provided an easy-to-operate solution to the thorny problem of huge medical expenses.

1988 On March 25th, with the approval of the State Council, a medical system reform plan led by the Ministry of Health, with the participation of the State Commission for Restructuring the Economy, the Ministry of Labor, the Ministry of Health, the Ministry of Finance and the General Administration of Medicine, was established to guide the medical reform pilot. In July of the same year, the Group launched the Assumption of Employee Medical Insurance System (Draft). 1989, the Ministry of Health and the Ministry of Finance promulgated the "Notice on the Management Measures of Public Medical Care", which explained the specific 13 self-funded items within the scope of public medical care expenditure. In March of the same year, the State Council approved the "Essentials of Economic System Reform" 1989 issued by the State Commission for Economic Restructuring, pointing out that medical insurance system reform should be piloted in Dandong, Siping, Huangshi and Zhuzhou, and comprehensive social security system reform should be piloted in Shenzhen and Hainan.

Under the guidance of relevant policies, Siping City, Jilin Province took the lead in carrying out the medical insurance pilot, and Bishan County, Chongqing City also made some reform attempts according to the pilot scheme. 1April, 1990, Siping's free medical care reform plan was introduced; In June 199 1, 1 1, Hainan Province promulgated the Interim Provisions on Medical Insurance for Employees in Hainan Province, which came into effect on June 1992. 1991September, Shenzhen Medical Insurance Bureau was established.1May, 1992, the Interim Provisions on Medical Insurance for Employees in Shenzhen and the Detailed Rules for the Implementation of Medical Insurance for Employees were promulgated. During the period of 1994, the State Commission for Economic Restructuring, the Ministry of Finance, the Ministry of Labor and the Ministry of Health jointly formulated the Pilot Opinions on the Reform of the Employee Medical System, which was approved by the State Council and piloted in Zhenjiang City, Jiangsu Province and Jiujiang City, Jiangxi Province, namely the famous "Two Rivers Pilot".

On the basis of the "Two Rivers Pilot Project",1April 1996, the General Office of the State Council forwarded the Opinions of the State Commission for Economic Restructuring, the Ministry of Finance, the Ministry of Labor and the Ministry of Health on Expanding the Pilot Reform of Workers' Medical Security System and Carrying out a Wider Pilot Project.

According to the unified deployment, 1997 selected 58 cities for medical security pilot. As of the beginning of August, more than 30 cities have launched pilot projects to expand medical reform. By the end of 1998, there were 40 employees 17000 and retirees17000, and the income of medical insurance fund in that year reached1950 billion yuan. By 1999, all 58 cities identified as pilot areas have carried out pilot work.

The "Two Rivers Pilot Project" initially established a medical insurance model for urban workers with "unified account" (the combination of social planning and personal account). This model has been well received by the expanded pilot association. At the same time, many cities in China have carried out some reforms and explorations on the payment mechanism in accordance with the principle of "unified accounting and combination". In addition to the "three-channel" model of "Two Rivers Pilot Project", the specific models of unified account integration mainly include: Shenzhen mixed model, that is, different levels of insurance models are implemented for different types of people, mainly including comprehensive medical insurance, inpatient medical insurance and special medical insurance; Hainan's "two-track parallel" model adopts the way of separate management of individual accounts and social pooling funds. The latter is used to pay for hospitalization expenses and cannot be overdrawn by the former. It is managed and operated by the Social Security Bureau. The basic practice of Qingdao's "three funds" model is to add a unit adjustment fund between the establishment of individual account fund and the overall medical fund, which will be paid by enterprises and individual employees, and the unit adjustment fund and individual account fund will be managed by enterprises.

(2) The second stage (1998): the establishment of urban basic medical insurance system. 19981998 In February, the State Council held a national conference on the reform of the medical insurance system, and issued the Decision of the State Council on Establishing the Basic Medical Insurance System for Urban Employees, which clarified the objectives, tasks, basic principles and policy framework of the medical insurance system reform, and demanded that the basic medical insurance system covering all urban employees be established nationwide from 65438 to 0999. With the publication of this document as a symbol, the establishment of medical insurance system for urban workers in China has entered a stage of all-round development.

The establishment of urban basic medical insurance system in China has played a very important role in ensuring the health of urban workers and promoting social harmony and stability. Since the formal implementation of 1999 system, the coverage of the system has been expanding and good social effects have been achieved.

(3) the third stage (1999~2006): the exploration of multi-level medical security system in cities and towns.

First, expand the basic medical insurance system. Since the establishment of the urban basic medical insurance system, the scale has been expanding and the coverage has been expanding. For example, in 1999, the General Office of the State Council and the General Office of the Central Military Commission jointly issued the Interim Measures for the Medical Insurance of Retired Soldiers of the People's Liberation Army of China, stipulating that the state should implement the medical insurance system for retired soldiers, set up a medical insurance fund for retired soldiers, and subsidize the medical expenses of retired soldiers; 65438-0999 The Ministry of Labor and Social Security issued the Notice on Issues Related to Railway System Employees' Participation in Basic Medical Insurance to guide the railway system employees to change from the original labor insurance medical system to social medical insurance.

As early as 1996, Shanghai took the lead in launching the "Shanghai Children's Hospitalization Mutual Fund". More than 95% of students and preschool children in Shanghai joined the fund guarantee system, effectively reducing the financial burden of children's families. On September 1 day, 2004, Beijing Medical Mutual Fund for Primary and Secondary School Students and Infants was officially launched. Hebei, Guangdong, Jiangsu, Zhejiang, Jiangxi, Jilin, Sichuan and other provinces have issued corresponding policies.

In May 2003, the Ministry of Labor and Social Security issued the Guiding Opinions on Flexible Employment in Cities and Towns to Participate in Medical Insurance, and in May of the following year, it issued the Opinions on Promoting Employees of Mixed Ownership Enterprises and Non-public Economic Organizations to Participate in Medical Insurance, which included flexible employment, employees of mixed ownership enterprises and non-public economic organizations, and migrant workers in rural areas into the coverage of medical insurance. In 2004, Jiangxi Province issued the "Trial Measures for Flexible Employment in Cities and Towns in Jiangxi Province to Participate in Basic Medical Insurance", which included flexible employment in cities and towns and Chengguan towns in counties into the coverage of basic medical insurance. On May 24, 2004, Jiujiang City, Jiangxi Province further improved the medical insurance policy for flexible employees, which was implemented in July 2004 1. On June 5438+0 1 day, 2004, Wuhan City, Hubei Province promulgated the Basic Medical Insurance Measures for Flexible Employees in Cities and Towns in Wuhan, which was implemented on June 5438+February/day of the same year. On June 5438+February, 2005, Guangzhou City, Guangdong Province included flexible employees in medical insurance coverage, realizing the "full coverage" of the local registered working-age population. Nanjing, Guizhou, Chongqing, Taiyuan, Baoding, Zhangjiakou, Shantou, Mudanjiang, Shenyang and other cities have issued relevant policies.

Since 2006, the medical insurance system has listed migrant workers as a covered population. On March 27th, 2006, the State Council issued "Several Opinions of the State Council on Solving the Problems of Migrant Workers", proposing to actively and steadily solve the social security problems of migrant workers.

In May 2006, the Ministry of Labor and Social Security issued the Notice on Launching the Special Expansion Action of Migrant Workers' Participation in Medical Insurance, proposing that "the provincial capitals and large and medium-sized cities should be the focus, and the processing and manufacturing industries, construction industries, extractive industries and service industries where migrant workers are concentrated should be the focus, and migrant workers who have established labor relations with employers in cities and towns should be comprehensively planned, classified and implemented step by step".

Second, develop the medical assistance system. Before 2005, there was no national medical assistance system in China. In July 2005, the General Office of the State Council forwarded the Opinions on Establishing a Pilot System of Urban Medical Assistance issued by the Ministry of Civil Affairs, the Ministry of Health, the Ministry of Labor and Social Security and the Ministry of Finance in April 2005, pointing out that starting from 2005, it will take two years to carry out pilot projects in some counties (cities, districts) in various provinces, autonomous regions and municipalities directly under the Central Government, and then it will take two to three years to establish urban medical assistance with institutionalized management and standardized operation nationwide.

The "Opinions" pointed out that it is necessary to carefully select pilot areas and establish urban medical assistance funds. The Opinions also stipulate that the relief targets are mainly those who have not participated in the basic medical insurance for urban workers, those who have participated in the basic medical insurance for urban workers but still have a heavy personal burden, and other people with special difficulties.

Third, develop supplementary medical insurance. China has been encouraging employers to establish supplementary medical insurance system for employees. Article 75 of the Labor Law stipulates that "the state encourages employers to establish supplementary insurance for workers according to actual conditions". The State Council's "Decision on Establishing the Basic Medical Insurance System for Urban Workers" also proposes that "the medical insurance expenses (basic medical insurance) exceeding the maximum payment limit can be solved by means of commercial medical insurance". Chengdu, Sichuan, 65438-0996, China piloted supplementary medical insurance earlier. Supplementary medical insurance in China has the following forms:

The first is the state's medical subsidies for civil servants. According to the "Decision on Establishing the Basic Medical Insurance System for Urban Workers", national civil servants enjoy the Medicaid policy on the basis of participating in the basic medical insurance. This Medicaid policy is actually supplementary medical insurance for civil servants. The purpose of implementing this supplementary medical insurance is to ensure that the medical treatment level of national civil servants will not decline compared with that before the reform.

The second is the supplementary medical insurance carried out by social medical insurance institutions. This form of supplementary medical insurance is provided by the social medical insurance agency on the basis of compulsory "basic medical insurance", and its insurance deductible line is connected with the "capping line" stipulated by the basic medical treatment, giving a higher proportion of compensation to some employees who encounter high medical expenses, which can really spread risks and reduce the burden on employers and sick employees. Because social medical insurance institutions have certain advantages in raising, managing and controlling the medical expenses of supplementary medical insurance funds, this form is a good way to solve the problem of supplementary medical insurance for employees. It should be noted that the supplementary medical insurance fund and the basic medical insurance fund shall be independent of each other and shall not be overdrawn. At the same time, we should actively expand the scale of supplementary medical insurance and improve the anti-risk ability of supplementary medical insurance funds.

The third is the supplementary medical insurance provided by commercial insurance companies. Supplementary medical insurance introduced by commercial insurance companies can be divided into two situations: one is that units and individuals who have participated in "basic medical insurance" apply to commercial insurance companies for supplementary medical insurance to compensate for high medical expenses, such as Xiamen model. The "top line" of "basic medical insurance" is the deductible line of commercial supplementary medical insurance, and the high medical expenses above the deductible line are borne by commercial medical insurance, but commercial insurance companies generally still stipulate the upper limit of compensation, such as the annual compensation amount does not exceed 6,543,805 yuan or 200,000 yuan. At present, some domestic commercial insurance companies have actively intervened in the supplementary medical insurance market. However, due to the high risk and difficult management of high medical insurance, only China Pacific [7.69 -4.35% share research] insurance company and China Ping An [33.57-1.4 1% share research] insurance company have carried out some activities in some areas. It is estimated that there is still a process for commercial insurance companies to underwrite such business on a large scale. On the other hand, commercial insurance such as "critical illness insurance" and "cancer insurance" provided by major commercial insurance companies for certain special diseases can also provide a certain degree of compensation for employees' high medical expenses beyond the "capping line".

In addition, the supplementary medical insurance system also includes mutual insurance for employees organized and operated by trade unions, that is, mutual insurance business is mainly carried out by using the original trade union organization system. The exploration of supplementary medical insurance system is conducive to improving the level of the insured, thus resisting the greater risk of medical expenses, thus forming a medical security system for urban workers in China with multi-level security, multi-channel security funds, scientific payment and effective management.

(4) The fourth stage (2007): urban residents' medical insurance system pilot. The Third Plenary Session of the 16th CPC Central Committee put forward the resolution of "expanding the coverage of basic medical insurance". In 2006, the Sixth Plenary Session of the 16th CPC Central Committee adopted the Decision of the Central Committee on Several Major Issues Concerning the Construction of a Harmonious Socialist Society, which further clearly stated that "medical insurance for urban residents should be established on the basis of overall planning for serious illness". From the second half of 2004, the establishment of medical security system for urban residents was discussed, and in 2005, the scheme research and design work was carried out for more than one year. At the same time, some local-led pilots are also being launched.

In April, 2007, Premier Wen Jiabao of the State Council presided over the the State Council executive meeting, and decided to carry out the pilot project of the basic medical insurance system for urban residents, and made it clear that in 2007, the pilot project of establishing the basic medical insurance system for urban residents will be carried out in 1 2 cities where conditions permit. The pilot of basic medical insurance for urban residents began in the second half of 2007. Summarize the pilot experience in 2008 and continue to promote it. It is expected to be launched nationwide in 2009. The core of rural medical security system is rural cooperative medical system. The rural cooperative medical system has played an important historical role in developing economy, stabilizing society and ensuring people's health. This system, once highly praised by the World Health Organization, has experienced extremely bumpy ups and downs. Today's new cooperative medical system is in full swing. Reviewing the system with China characteristics formed in this specific historical period will help to improve the rural medical security system, and ultimately provide reference experience for building a medical security system covering urban and rural areas.

(1) The development and reform process of rural cooperative medical system in the first stage (1978~2003). As early as the 1940s, medical cooperatives with the nature of health cooperation appeared in the Shaanxi-Gansu-Ningxia Border Region. After the founding of New China, with the continuous upgrading of agricultural cooperation, the rural cooperative medical system has also been greatly developed.

After the "Cultural Revolution", cooperative medical care was written into the Constitution of People's Republic of China (PRC) adopted by the First Session of the Fifth National People's Congress on March 5, 1978. 1979 12 15, the Ministry of Health, the Ministry of Agriculture, the State General Administration of Medicine, and the All-China Federation of Supply and Marketing Cooperatives jointly issued a notice to issue the Regulations on Rural Cooperative Medical System (Trial Draft), requiring all localities to refer to the actual situation in their respective regions.

In the early 1980s, rural areas carried out economic system reform and began to implement the household contract responsibility system. The family became the basic business unit of agricultural production again, and the collective economy gradually disintegrated. The cooperative medical system based on the collective economy has lost its main source of funds. In addition, when the cooperative medical system was popularized during the Cultural Revolution, there were problems such as formalism and uniformity across the board, which made some people regard the cooperative medical system as a "left" thing and totally deny it. In addition, there are also some problems in the operation of the cooperative medical system, such as poor management and poor supervision, which leads to the disintegration of the cooperative medical system in a large area and is on the verge of collapse.

Since 1990, China has entered the stage of establishing a socialist market economic system, and the problem of "how to establish a rural medical security system in the new period" is inevitably before us. Therefore, China has made a difficult exploration on the recovery and reconstruction of cooperative medical care. 1993 the Central Committee of the Communist Party of China put forward the idea of "developing and perfecting the rural cooperative medical system" in the Decision on Establishing the Socialist Market Economic System. From 65438 to 0993, the Policy Research Office of the State Council and the Ministry of Health carried out extensive investigation and research nationwide, and put forward a research report on "accelerating the reform and construction of rural cooperative medical system". 1994, in order to provide a theoretical basis for the legislation of cooperative medical care, the Research Office of the State Council, the Ministry of Health and the Ministry of Agriculture cooperated with the World Health Organization to carry out a pilot and follow-up study on "the rural cooperative medical care system reform in China" in seven provinces 14 counties. 1In July, 1996, the Ministry of Health held a national experience exchange meeting on rural cooperative medical care in Henan, and put forward specific measures to develop and improve cooperative medical care. 199665438+In February, the Central Committee of the Communist Party of China and the State Council held a national conference on health work, which once again emphasized the importance of cooperative medical care in improving farmers' health level and developing rural economy. 1997 65438+ 10, the Central Committee and the State Council issued the Decision on Health Reform and Development, demanding "actively and steadily develop and improve the rural cooperative medical system" and "strive to establish various forms of cooperative medical system in most rural areas by 2000, and gradually improve the degree of socialization; Conditional places can gradually transition to social medical insurance. " In May of the same year, the State Council approved the Opinions on Developing and Perfecting the Rural Cooperative Medical System issued by the Ministry of Health, the State Planning Commission, the Ministry of Finance, the Ministry of Agriculture and the Ministry of Civil Affairs, which promoted the recovery and development of the rural cooperative medical system to a certain extent.

(2) The second stage: (2003-present) the new rural cooperative medical care reform;

On June 65438+1October 65438+1October 9, 2002, the Central Committee of China and the State Council promulgated the Decision on Further Strengthening Rural Health Work, demanding that "by 2065, a rural health service system and a rural cooperative medical system that meet the requirements of the socialist market economic system and the level of rural economic and social development will be basically established in rural areas throughout the country". It is clearly pointed out that the medical service system for serious diseases in rural areas should be gradually established. On March 1 day, 2003, the newly revised Agricultural Law of People's Republic of China (PRC) came into effect, stipulating that "the state encourages and supports farmers to consolidate and develop rural cooperative medical care and other forms of medical security to improve their health level". Since then, the development and improvement of rural cooperative medical system has laws to follow.

On June 65438+1October 65438+June 2003, the General Office of the State Council forwarded the opinions of the Ministry of Health, the Ministry of Finance and the Ministry of Agriculture on the establishment of a new rural cooperative medical system, demanding that "from 2003, all provinces, autonomous regions and municipalities directly under the Central Government should select at least 2-3 counties (cities) for pilot projects, and gradually push them forward after gaining experience. By 20 10, we will achieve the goal of establishing a new rural cooperative medical system that basically covers rural residents throughout the country, reduce the economic burden caused by farmers' illness, and improve the health level of farmers. " "The new rural cooperative medical system is generally coordinated by the county (city)". "The new rural cooperative medical system implements a financing mechanism that combines individual contributions, collective support and government funding. The annual payment standard for individual farmers shall not be lower than 10 yuan. Conditional rural collective economic organizations should give appropriate support to the local new rural cooperative medical system. The specific payment standard shall be determined by the people's government at the county level, but the collective payment shall not be shared with farmers. Encourage social organizations and individuals to fund the new rural cooperative medical system ". "The local financial subsidies for farmers participating in the new rural cooperative medical system are not less than 10 yuan every year.

On June 5438+ 10/0, 2006, seven ministries and bureaus, including the Ministry of Health, the National Development and Reform Commission, the Ministry of Civil Affairs, the Ministry of Finance, the Ministry of Agriculture, the US Food and Drug Administration and state administration of traditional chinese medicine, jointly issued the Notice on Accelerating the Pilot Work of the New Rural Cooperative Medical System, which fully affirmed the new rural cooperative medical system. It is considered that "the establishment of a new rural cooperative medical system is an important measure to solve the problem of farmers' difficulty in seeing a doctor based on China's basic national conditions, which plays an important role in improving farmers' health level, alleviating farmers' poverty caused by illness, coordinating urban and rural development, and realizing the goal of building a well-off society in an all-round way." It is put forward that "all provinces (autonomous regions and municipalities) should intensify their work, improve relevant policies and expand the pilot of the new rural cooperative medical system on the basis of earnestly summing up the pilot experience. In 2006, the number of pilot counties (cities, districts) in China will reach about 40% of the total number of counties (cities, districts) in China; In 2007, it expanded to about 60%; In 2008, it was basically implemented nationwide; In 20 10, the new rural cooperative medical system will basically cover rural residents. "At the same time, we will increase financial input." From 2006, the central government will increase the annual subsidy for farmers participating in the new rural cooperative medical system in the central and western regions from per person 10 yuan to 20 yuan, and the local finance will also increase accordingly 10 yuan. The cooperative medical subsidy funds increased by local finance should be mainly borne by provincial finance. In principle, it should not be shared equally by provinces, cities and counties in proportion, and the financial burden of difficult counties cannot be increased. "After the reform and opening up, with the gradual improvement of the market economy, China's pharmaceutical industry has developed rapidly, and various pharmaceutical companies have sprung up. At the same time, drug production access and new drug approval have become the focus of drug management system. 1978 the State Council approved the promulgation of the Regulations on Drug Administration, 1979 The Ministry of Health organized the formulation of the Measures for the Administration of New Drugs. From 65438 to 0984, China promulgated the Drug Administration Law, which was also regarded as the embryonic form of China's drug control system. It stipulates the market access mechanism of drugs, that is, "to set up pharmaceutical production enterprises and pharmaceutical trading enterprises, it must be examined and approved by the competent departments of pharmaceutical production and marketing in provinces, autonomous regions and municipalities directly under the Central Government, and approved by the health administrative departments of provinces, autonomous regions and municipalities directly under the Central Government, and then a Pharmaceutical Production Enterprise License and a Pharmaceutical Trading Enterprise License shall be issued. Without these two certificates, the administrative department for industry and commerce shall not issue a business license. "However, due to the division of power among various departments, this system has not been well implemented. 1985 The Ministry of Health has formulated and promulgated the Measures for the Examination and Approval of New Drugs according to the Drug Administration Law. Since then, the management and approval of new drugs in China has entered the stage of legalization. 65438-0988 The Ministry of Health issued the Supplementary Provisions on the Administration of New Drug Approval, which further improved the approval of new drugs. 1992 The Ministry of Health issued the Notice on Several Issues Concerning the Administration of Drug Approval again, and at the same time made supplementary provisions for Chinese medicine and biological products respectively.

From 1984 to 10, drug production management has been in a state of chaos. 1994, the State Council issued the Emergency Notice on Further Strengthening Drug Management (Guo Fa [1994] No.53), which was actually an informal revision of the Drug Administration Law, allowing the drug market to enter. However, the pattern of multi-head management in the pharmaceutical industry has not been improved, but has been further deepened.

1996, the general office of the State Council issued the notice on continuing to rectify and standardize the order of drug production and operation and strengthening drug management (Guo ban fa [1996] 14), which summarized the problems existing in drug management: unlicensed or incomplete licenses, and serious illegal drug production and operation by renting or transferring licenses.

1998 Promulgates the Management Standard for Drug Clinical Trials in China (for Trial Implementation). In August, 1998, the State Administration of Pharmaceutical Products was formally established. From 65438 to 0999, the State Administration of Pharmaceutical Products officially promulgated five laws and regulations, including the Measures for the Examination and Approval of New Drugs, the Measures for the Examination and Approval of New Biological Products, the Measures for the Administration of Imported Drugs, the Measures for the Examination and Approval of Generic Drugs, and the Provisions on the Protection of New Drugs and Technology Transfer. Many of these laws and regulations refer to the international common practices, marking an innovative attempt of drug management in China.

200 1, the 9th NPC Standing Committee of People's Republic of China (PRC) passed the revised Drug Administration Law of People's Republic of China (PRC). The Regulations for the Implementation of the Drug Administration Law of People's Republic of China (PRC) promulgated in August 2002 further refined the relevant provisions in the Drug Administration Law. In terms of production quality, in June, 2005, 10, the Administrative Measures for Certification in good manufacturing practice came into effect.

From June 5438 to February 2002, the newly revised Measures for the Administration of Drug Registration of the State Administration of Pharmaceutical Products (Trial) was implemented. Five administrative regulations, such as the Measures for the Examination and Approval of New Drugs, the Measures for the Examination and Approval of New Biological Products, the Provisions on the Protection of New Drugs and Technology Transfer, the Measures for the Examination and Approval of Generic Drugs and the Measures for the Administration of Imported Drugs, issued by 1999, shall be abolished at the same time. On May 1 2005, the Measures for the Administration of Drug Registration promulgated by the US Food and Drug Administration came into effect. In 2007, the Measures for the Administration of Drug Registration was revised again, and it came into effect on June 65438+ 10/day of the same year. There have always been problems in drug registration management, especially the approval of new drugs, the repeated appearance of a large number of generic drugs, and the lack of innovative mechanisms in the pharmaceutical industry, which need further study and solution. Preparation stage: 1978~ 1995. At present, there are not many policies directly related to drug prices, mainly the establishment of some drug management institutions and some macro-policy documents, which create conditions for the next stage of price management.

Implementation stage of reform: 1996 till now. Drug price management began with the Interim Measures for Drug Price Management issued in August, 1996. At this time, the drug price was mainly rectified around the goal of "reducing the inflated drug price and reducing the burden of patients' drug expenses", and later the Supplementary Provisions on the Interim Measures for the Administration of Drug Price was promulgated.

1At the end of 1998, the State Planning Commission issued the Notice of the State Planning Commission on Perfecting Drug Price Policy and Improving Drug Price Management, and local price departments successively lowered drug prices several times.

The year of 2000 was a year in which China thoroughly rectified drug prices. With the release of the Guiding Opinions on the Reform of Medical and Health System in Cities and Towns, the State Planning Commission issued the Opinions on the Reform of Drug Price Management in July. At this time, the documents on drug prices mainly include: Opinions on Reforming Drug Price Management, Several Provisions on the Pilot Work of Centralized Bidding and Purchasing of Drugs in Medical Institutions, Measures for Qualification Identification and Supervision and Management of Drug Bidding Agencies, Measures for Government Pricing of Drugs, Catalogue of Drugs Pricing by the State Planning Commission, Measures for Examination and Approval of Drug Government Pricing Declaration, and Measures for Drug Price Monitoring. These policies further promoted the reform of drug price management.

Since then, with the problem of high drug prices, the state has continuously introduced drug price reduction policies: in May of 200 1 year, the State Planning Commission issued a notice announcing the highest retail prices of 69 drugs; In 2004, the National Development and Reform Commission and the Ministry of Health jointly issued the Notice on Further Strengthening the Supervision of Medical Price and Reducing Social Medical Expenses, requiring all departments to continue to reduce the prices of government-priced drugs. In 2005, the state reduced the maximum retail price of 22 kinds of drugs; In June, 2007, 5438+ 10, the National Development and Reform Commission issued the notice No.21to reduce the drug price, followed by the notice No.22 on setting the maximum retail price of 278 kinds of Chinese patent medicines such as Jiuwei Qianghuo Granules, and adjusted the maximum retail price of 260 kinds of drugs in May. In 2006, the National Development and Reform Commission (NDRC) formulated the Measures for Drug Pricing in the Pharmaceutical Industry based on the principle of the Measures for Supervision and Examination of Price Cost Formulated by the Government, and its draft for comments has been formed and is being solicited. Generally speaking, in recent 10 years, China has reduced drug prices for 23 consecutive times, but due to various reasons, the problems of "inflated prices" and "expensive medical treatment" in China have not been effectively solved.