The just-initiated 2008 was a memorable year in the history of China's drug administration reform. Ten years ago, in order to rectify the chaotic situation of multi-headed management in the pharmaceutical management system at that time and rectify the illicit drug market, the National People’s Congress passed the “Decision on Institutional Reform Plan of the State Council†and decided to set up a new State Drug Administration to become a The administrative law enforcement department of the State Council in charge of drug supervision intends to create an FDA brand with Chinese characteristics. Ten years later, the same "Decision on the Institutional Reform Program of the State Council" decided to change the State Food and Drug Administration to the Ministry of Health. In the past decade, China’s reform of the drug administration has been tarnished by thorns. It has gone through storms and has accumulated experience and lessons. What kind of historical logic does the reform of China's drug administration really follow? What achievements have been made and what are the bottlenecks that are difficult to break through? What are the directions for future reforms?
Ten-Year Achievements: Building the Basic System of Drug Supervision The most important characteristics of modern regulatory countries include independence, professionalism, legality, and impartiality, and independence is the most fundamental. The reform of drug administration since 1998 has, to some extent, effectively improved the administrative independence and industrial independence of the regulatory authorities. For example, in terms of improving administrative independence, the reform in 1998 historically centralized the administrative supervision power of pharmaceutical quality to a vice ministerial organization of the State Drug Administration, and upgraded it from the original subsidiary of the Ministry of Health to the State Council. The directly-affiliated departments have greatly improved the independence of the drug regulatory authorities in the allocation of horizontal power and are conducive to the unification of the national drug regulatory power at the horizontal level. From the perspective of vertical relationship, the drug implemented from 1998 to 2002 has been promoted. The provincial and sub-provincial provincial vertical management reforms have unified the financial authority and personnel rights of provincial-level drug regulatory agencies to provincial drug regulatory agencies, and strengthened provincial-level and county-level drugs for relatively weak regulatory capacity. The supervisory department's ability to guide effectively relieved the problems of local protectionism caused by the parallel management system. In addition, the drug approval authority has received centralized reforms such as the centralized conversion of central and pharmaceutical standards into national standards. It has also successfully managed to centralize the regulatory authority for drug approvals scattered locally, which greatly strengthened the central government's supervision over drug quality. The power and status have greatly improved the administrative independence of the supervisory authority in the vertical direction.
In terms of improving industrial independence, China's pharmaceutical supervisory reforms have also made some breakthroughs. During the five years from 1998 to 2003, the newly established drug administration departments across the country have basically completed the reform of separation of government and enterprises, separation of industry management and quality supervision in the system, and it is difficult to implement the decoupling between the government and enterprises that emerged in the middle. In the case of the government, the government has become a third-party regulator representing the health benefits of consumers. Pharmaceutical companies and medical institutions have become the supervisors under the regulatory legal system. From the perspective of institutional norms, the operating expenses of the drug regulatory agency as the regulatory authority should be fully included in the government's budget, and no longer be collected from the regulatory object; drug regulatory agencies can no longer directly engage in drug production, management, and medical services, etc. For profit-making activities, it is also impossible to directly organize various economic entities and really withdraw from the operational market activities. Another bright spot in the reform is the reform of the funded system for sampling and inspection of pharmaceuticals. Since 2000, the central government has begun to reform the original system of sampling and inspection funds that highly depends on the company's fees and charges, plans for the sampling of pharmaceuticals, and funds for supervision and inspection. The source changed from charging enterprises to being allocated by the government, which reversed the propensity of drug control agencies to facilitate profit-taking in the drug sampling process, and effectively improved the independent and scientific supervision of drug quality and technology supervision departments relative to the industrial sector.
The premise of establishing an effective social supervision system is that the supervisor must fully grasp the information of the regulatory object, and guide and encourage the regulatory object to provide true, effective, comprehensive, and timely supervision information. The pharmaceutical quality control system at the time was basically out of order in obtaining information on management and control. The reform of the drug administration system that began in 1998 mainly strengthened supervision information capabilities from three aspects: in terms of information acquisition capabilities, from 1998 Since the beginning of the year, the drug administration department has gradually established a nationwide unified monitoring network for adverse drug reactions, encouraging and inducing drug production, operating companies, and medical institutions to report adverse drug reactions in an accurate and timely manner in various forms. In the past ten years, not only has the number of reports on adverse drug reactions collected by the regulatory authorities increased sharply, but the quality of the reports has also been increasing. The basic network platform for the monitoring of adverse drug reactions has been established, and the government’s information on adverse drug reactions has been established. Significant increase in acquisition capacity;
In terms of information discriminating ability, in addition to the implementation of the drug classification management system, the mandatory implementation of GMP and GSP certification is the main example. The mandatory implementation of GMP and GSP certification began at the beginning of the 20th century, and a set of quality management regulations was imposed on production and management companies through administrative orders, and through this relatively high threshold setting, the number of pharmaceutical companies was reduced and the number of pharmaceutical companies increased. The overall quality of the pharmaceutical industry operations. The two "G" compulsory certifications have successfully eliminated a group of backward SMEs in terms of objective effects, standardized the competitive behavior of pharmaceutical production and operations, and initially contained excessive competition in low-level redundant construction, greatly reducing the future of Chinese medicines. The difficulty of quality supervision. At the same time, the pharmaceutical classification management system that has been implemented for several years also classifies a wide variety of listed drugs into two categories, prescription drugs and non-prescription drugs, and divides and treats them according to their respective characteristics in terms of safety and effectiveness, reducing the difficulty of supervision and saving. Regulatory costs.
In terms of information integration capabilities, the merger of institutions at the horizontal level and the unified standards at the vertical level have effectively improved the information integration capabilities of regulatory agencies. Since the establishment of the State Food and Drug Administration in 1998, the State has taken a clear view of the information hurdles between the interministerial departments by translating the supervisory rights between the sanitary administrative department and the pharmaceutical administrative department at the horizontal level. In the enterprise approval, drug review, administrative law enforcement and other major aspects of unified standards, information sharing. At the vertical level, the central government also adopted a series of reforms such as the approval of drug types for approval, the withdrawal of local standards for drugs, and the unification of drug approval numbers, with the intention of eliminating the failure of local government in regulatory information and the quality of drugs at the central and provincial levels. Regulatory information is integrated and shared, and a computer network system covering national bureaus and provincial bureaus is established by launching the integrated application system of the internal network of the drug administration system to achieve network interconnection and interoperability.
In addition, how to strengthen the infrastructure construction of drug supervision under the existing conditions and environment, from the financial funds, personnel team construction and equipment replacement, has become one of the important policy objectives of the regulatory reform since 1998. From the point of view of financial support, as of July 2002, 31 provincial-level drug administrations nationwide implemented a total of 1.12 billion yuan in funds, including 681 million yuan in personnel expenses, 178 million yuan in random inspection funds, and 1.26 yuan in equipment costs. Billion yuan, construction funds 37.19 million yuan, and other supervisory funds 99 million yuan. Compared with the situation before 1998, the proportion of expenditures of funds at the same level of government finances has continuously increased, showing that the status of drug supervision work in the overall work of the government has steadily increased. .
From the point of view of the construction of the talent team, the number of personnel and the professional accomplishments of the drug administration personnel have all improved. In 1991, there were 1,660 drug, drug, and drug supervisor agencies in the country with only 3,466 employees at all levels. There were 1833 drug testing institutes and 19,761 employees. By the end of 2006, the total number of administrative agencies at all levels of the national drug administration system was 2,630, and 1,000 were public institutions. The administrative organs of the drug administration system had issued a total of 45,316 and a total of 12,506 inspectors of various types, of which the provincial drug administration system had a university degree. The above-mentioned personnel accounted for 44%, the prefecture-level drug supervisory system had 35% of the university-educated personnel, and the county-level pharmaceutical supervisory system had 67% of the academic-educated personnel, and the personnel with professional background in pharmacy, medicine, law and chemistry were employed. The ratio increased significantly. Therefore, the quality of the staff of the drug administration system has improved, both in terms of the total number of establishments, academic level, and professional literacy.
By systematically strengthening regulatory independence, improving regulatory information capabilities, and improving regulatory infrastructure, China's pharmaceutical supervisory reforms have implemented a guideline of “supervision, help, and promotion†for ten years to balance the development of the industry. The middle course of quality supervision has basically completed the initial stage of “establishing a basic regulatory system†for the reform of China's drug administration, including a series of basic regulatory systems including GMP and GSP certification, reports on adverse drug reactions, funding for sampled drugs, and so on. Initially established and effectively operated, the quality of medicines has improved: From the point of view of the qualified rate of nationwide drug product sampling inspections, it was only 83.5% in 1997, and it increased to 89% in 1998. The sampling pass rate from 1999 to 2002 was 93% respectively. , 95%, 97%, and 96.9%, showing an upward trend year after year, showing a steady increase in the quality of Chinese medicines. Therefore, the achievements of the Decade of Drug Administration reform cannot be erased.
Five major bottlenecks to deepen reform The strong concern for industrial development – ​​the willingness to oversee conflicts: Due to the strong inertia of the old system, the existing pattern of profit distribution between the government, enterprises, and institutions, as well as inadequate supervision reforms The regulatory authorities are still unable to completely get rid of the embarrassment of promoting industrial development, and once again fall into the quagmire of conflict-free regulatory will. Leading cadres from the pharmaceutical management department have long been engaged in the industry management of the pharmaceutical industry, and their leading work thinking and style have a strong industrial development. Compared with the quality and safety of pharmaceuticals, they are more concerned about How to realize the value-added maintenance of state-owned assets and how to promote the rapid development of China's pharmaceutical industry.
Some local governments regard the pharmaceutical industry as an important carrier for revitalizing local economic development, raising tax resources, and solving social employment. They also provide key protection for pharmaceutical companies within their jurisdiction, and regard the pharmaceutical supervision department as an industry management department for the pharmaceutical industry. Drug regulatory departments have devoted a considerable part of their efforts to attracting investment and serving pharmaceutical companies, relaxing their supervisory responsibilities and forcing grass-roots drug regulatory agencies that are already in a weak position to devote a considerable part of their energy to attracting investment and developing the pharmaceutical economy. On non-regulatory matters. In terms of information collection, some provinces’ drug administration departments are not only responsible for collecting information related to drug quality, but also require the subordinates to collect information data on the development of the pharmacy's economy in the province, so that grass-roots medicine supervisors with The department has devoted considerable attention to the collection of non-regulatory information. All of this has greatly weakened the regulatory independence of grass-roots drug regulatory agencies, which has created a structural conflict in the supervision of pharmaceutical authorities.
The over-competitive industry pattern—high cost of regulatory information: The historical inertia that drew from the traditional model, and the policy factors such as drug price cuts and drug use and medicine led to a decline in the profit rate of the pharmaceutical industry. The establishment of a supervisory system did not Fundamentally changing the development pattern of the over-competitive pharmaceutical industry, the biggest challenge to the quality supervision of pharmaceuticals is to greatly increase the cost of the regulatory authorities in obtaining and identifying real and effective regulatory information. Some increase, but the structural quality problems such as low quality of reports and single source still remain. The regulatory authorities' ability to grasp information on adverse drug reactions is still very limited. The huge loopholes in the design of drug review systems are given to unscrupulous manufacturers in the drug review process. Through tampering with data, stealing data, forging samples, altering processes, and reducing on-site production conditions, etc., the purpose of providing false or even wrong information to the regulatory authorities is to achieve the purpose of defrauding the regulatory authorities for approval; Landmarks in the national standard "movement, some Industry gradually to entice regulatory authorities through fraudulent way arbitrarily reduce the standard way that the nature of the sport began to be alienation.
The inertia of the command-planned economy—a highly administrative style of supervision: Although the mandatory implementation of GMP and GSP certification in pharmaceutical quality supervision in China is entirely reasonable, it is completely enforced through hard administrative measures, showing that the regulatory authorities are The administrative process is highly dependent on the regulatory process; in some places, the drug administration department stipulates that a certain distance cannot open two pharmacies at the same time, which is suspected of serious offsides; and frequent launches of various special rectification campaigns are incomplete. According to statistics, from 1999 to 2004, in the field of drug market regulation alone, the State Drug Administration Department has launched 10 special rectification campaigns, which essentially reflects the inability to establish institutionalized long-term mechanisms during the drug quality supervision process. The reality of inadequate regulatory capacity.
There is a lack of regulatory power structure that restricts and participates in rent-seeking regulatory corruption: a by-product of centralized reform is the high concentration of regulatory power in the drug registration department and officials, which inevitably leads to a series of regulatory corruption. In essence, the root cause of the series of corruption brought about by the reform of drug administration lies in the fact that after the central authorities have recovered important regulatory power, under the lack of an authoritative structure of effective monitoring agencies, strong drug regulatory power has made drug regulatory policy Both design and implementation cannot accept other effective restrictions from departmental powers and active participation in social rights, resulting in the consequences of “departmentalization of state powers†​​and “personalization of departmental powersâ€. In addition, the arduous task of drug supervision and weak drugs The gap between regulatory capabilities provides space for regulatory corruption, and the highly professional and over-competitive nature of the industry provides the possibility of regulatory corruption.
Conflicts between local developmentism and regulatory totalitarianism - still weak regulatory infrastructure construction: Since the drug surveillance system after the vertical management reform no longer belongs to the local local government sequence, the provincial governments no longer have financial appropriations for the drug surveillance system. The statutory obligations and supervision of drug safety have also started to fade away from the work appraisal system of local governments under the provincial government, and have turned into a potential conflicting regulatory goal with the general goal of local developmentism. With the exception of a few economically developed provinces on the eastern coast, most of the central and western provinces have very limited financial resources. Basically, they cannot fully allocate the required financial funds to the drug surveillance system after the implementation of the vertical management system. Effectively improving the technical supervision and inspection capabilities of the drug regulatory agencies has directly led to the weakening of the pharmaceutical supervision infrastructure in the provinces of the central and western regions under the developmental system, which has not been able to achieve significant improvement.
In summary, the five major bottleneck factors in the reform of the Drug Administration decade are its historical and institutional roots in the strong inertia of the planned economy and the development-oriented system, which has led to the emergence of partial regulatory failures, which has seriously constrained the reform of the pharmaceutical supervision system. The stage is to develop a quality supervision stage.
Towards Quality Supervision – The direction of China's drug regulatory reforms From the perspective of the process of establishing a national regulatory government, it generally takes a process from the initial stage of the regulatory system to the stage of high-quality regulation. In order to effectively improve the quality of supervision, in the future China's drug administration reform should focus on breakthroughs in the above five bottlenecks to advance in depth:
First, the drug administration department should not only re-position and reflect on the post-development supervision model of “supervising, helping, and promoting†from the actual political slogans. Local governments at all levels should separate the functions of promoting the development of the pharmaceutical economy and strengthening the management of the pharmaceutical industry from the drug regulatory agencies and assign them to economic development departments such as the National Development and Reform Commission or industry associations. They can no longer attract investment, develop the pharmaceutical economy, and establish pharmaceuticals. Markets, providing services for pharmaceutical companies, collecting information and information on the pharmaceutical industry, and other non-quality regulatory functions are included in the daily work of drug regulatory agencies.
Secondly, the drug regulatory authorities should focus their information acquisition and identification on the quality and safety of drugs themselves, including the true degree of declaration data in the drug registration process, whether the raw materials and accessories used in the production process and the production process are in compliance with GMP regulations, and business operations. Whether the transportation and sales of pharmaceuticals meets the GSP specifications and reports of adverse reactions in the use of links, the drug regulatory departments at different levels should establish an effective regulatory information division system based on the characteristics of the pharmaceutical industry chain: the State Bureau should focus on regulatory information The development, registration and production of pharmaceuticals should be carried out on the upstream and downstream chains of multiple industries so as to contain the practices of falsifying and cutting corners at the source; the local supervisory authorities should focus on improving the monitoring system for adverse drug reactions and the monitoring of downstream processes in the industries such as business use. , to strengthen the risk supervision of drug listing.
Third, in addition to traditional administrative measures, drug regulatory agencies can also use economic incentives and penalties, licensing systems, technical standards, information provision, property rights, subsidies, performance standards, and other tools in regulatory practices, making regulatory agencies Instead of relying solely on rigid regulatory measures, it will enable some flexible regulatory measures to achieve regulatory policy goals.
Fourth, from the perspective of balance of power, the next step of reform should be to split the overly centralized drug registration authority and implement the working mechanism of drug registration acceptance, technical review, and administrative approval separation, and strengthen technical review. The weight of the decision in the final administrative approval. The plan for the reform of the food and drug administration to the reform of the health sector reflects the central government’s intention to strengthen checks and balances by means of restricting power by means of power. At the same time, the National People’s Congress, the State Council, the Central Commission for Discipline Inspection, and the procuratorate departments should also strengthen the drug regulatory agencies. Inquiries and monitoring efforts, but can not go to the old road of decentralization. From the point of view of rights restriction, the drug administration department should actively foster relatively independent industry associations and consumer organizations, and empower some of the non-core regulatory powers through relatively empowering social organizations. With the help of the industry's self-regulatory and social supervisory powers to achieve regulatory objectives and to break the monopoly of the supervisory authority's complete monopoly of regulatory power, it can also greatly reduce the risks and costs of the regulatory authorities.
Finally, the key to effectively resolve the contradiction between local developmentism and regulatory centralism is to continue to implement unfinished vertical management reforms and implement a unified national vertical management of the drug surveillance system, instead of simply returning to the “local government’s overall responsibility†block management. era. Although the institutional reform of the drug surveillance system was replaced by the health department, the author believes that the drug surveillance system should still maintain a certain degree of relative independence. The national vertical management of the drug administration system can relatively separate the responsibility of the industry development and quality supervision, and completely supervise the drug regulatory function into the central government, which can not only better eliminate local protectionism in drug supervision, but also lead to The conflict between the development of local governments and their supervisory role will also help improve the overall quality of the drug administration team. Under the favorable environment in which the country puts food and drug supervision under the “Eleventh Five-Year Planâ€, whether it is the central government or local governments at all levels, it should increase financial input to the drug regulatory infrastructure construction in a timely manner and change the current drug surveillance system. Due to insufficient budgetary funds, it is necessary to pass through the extra-budgetary revenues such as administrative examination and approval, law enforcement fines, and other extrabudgetary revenues to make up for the abnormal fund-raising structure, thereby effectively improving the situation in which the local drug regulatory infrastructure is still weakened.
The ten-year history of China's drug administration reform focused on the microcosm of the construction of China's regulatory government. It fundamentally shows that after experiencing a highly centralized planned economic system and a relatively out-of-standard market economy, the government has strengthened the economy. The basic process and logic for effective supervision of order and product quality. The reform plan that the Food and Drug Administration changed to be managed by the health department is another beneficial attempt in such a basic logical process. Changes in the administrative structure can create certain conditions for the reform of the regulatory system, but it does not guarantee the realization of quality supervision at a glance. No matter how the specific institutional setup changes, the general trend of strengthening the function of drug safety supervision will only be strengthened and will not be weakened. We sincerely hope that after undergoing a series of trials and tribulations, the reform of China's drug administration will be able to move from the initial stage of "establishing a regulatory infrastructure system" to fostering a higher level of "quality supervision" mode in the following new decade. At the stage, it truly became the patron saint of Chinese people's health.
Ten-Year Achievements: Building the Basic System of Drug Supervision The most important characteristics of modern regulatory countries include independence, professionalism, legality, and impartiality, and independence is the most fundamental. The reform of drug administration since 1998 has, to some extent, effectively improved the administrative independence and industrial independence of the regulatory authorities. For example, in terms of improving administrative independence, the reform in 1998 historically centralized the administrative supervision power of pharmaceutical quality to a vice ministerial organization of the State Drug Administration, and upgraded it from the original subsidiary of the Ministry of Health to the State Council. The directly-affiliated departments have greatly improved the independence of the drug regulatory authorities in the allocation of horizontal power and are conducive to the unification of the national drug regulatory power at the horizontal level. From the perspective of vertical relationship, the drug implemented from 1998 to 2002 has been promoted. The provincial and sub-provincial provincial vertical management reforms have unified the financial authority and personnel rights of provincial-level drug regulatory agencies to provincial drug regulatory agencies, and strengthened provincial-level and county-level drugs for relatively weak regulatory capacity. The supervisory department's ability to guide effectively relieved the problems of local protectionism caused by the parallel management system. In addition, the drug approval authority has received centralized reforms such as the centralized conversion of central and pharmaceutical standards into national standards. It has also successfully managed to centralize the regulatory authority for drug approvals scattered locally, which greatly strengthened the central government's supervision over drug quality. The power and status have greatly improved the administrative independence of the supervisory authority in the vertical direction.
In terms of improving industrial independence, China's pharmaceutical supervisory reforms have also made some breakthroughs. During the five years from 1998 to 2003, the newly established drug administration departments across the country have basically completed the reform of separation of government and enterprises, separation of industry management and quality supervision in the system, and it is difficult to implement the decoupling between the government and enterprises that emerged in the middle. In the case of the government, the government has become a third-party regulator representing the health benefits of consumers. Pharmaceutical companies and medical institutions have become the supervisors under the regulatory legal system. From the perspective of institutional norms, the operating expenses of the drug regulatory agency as the regulatory authority should be fully included in the government's budget, and no longer be collected from the regulatory object; drug regulatory agencies can no longer directly engage in drug production, management, and medical services, etc. For profit-making activities, it is also impossible to directly organize various economic entities and really withdraw from the operational market activities. Another bright spot in the reform is the reform of the funded system for sampling and inspection of pharmaceuticals. Since 2000, the central government has begun to reform the original system of sampling and inspection funds that highly depends on the company's fees and charges, plans for the sampling of pharmaceuticals, and funds for supervision and inspection. The source changed from charging enterprises to being allocated by the government, which reversed the propensity of drug control agencies to facilitate profit-taking in the drug sampling process, and effectively improved the independent and scientific supervision of drug quality and technology supervision departments relative to the industrial sector.
The premise of establishing an effective social supervision system is that the supervisor must fully grasp the information of the regulatory object, and guide and encourage the regulatory object to provide true, effective, comprehensive, and timely supervision information. The pharmaceutical quality control system at the time was basically out of order in obtaining information on management and control. The reform of the drug administration system that began in 1998 mainly strengthened supervision information capabilities from three aspects: in terms of information acquisition capabilities, from 1998 Since the beginning of the year, the drug administration department has gradually established a nationwide unified monitoring network for adverse drug reactions, encouraging and inducing drug production, operating companies, and medical institutions to report adverse drug reactions in an accurate and timely manner in various forms. In the past ten years, not only has the number of reports on adverse drug reactions collected by the regulatory authorities increased sharply, but the quality of the reports has also been increasing. The basic network platform for the monitoring of adverse drug reactions has been established, and the government’s information on adverse drug reactions has been established. Significant increase in acquisition capacity;
In terms of information discriminating ability, in addition to the implementation of the drug classification management system, the mandatory implementation of GMP and GSP certification is the main example. The mandatory implementation of GMP and GSP certification began at the beginning of the 20th century, and a set of quality management regulations was imposed on production and management companies through administrative orders, and through this relatively high threshold setting, the number of pharmaceutical companies was reduced and the number of pharmaceutical companies increased. The overall quality of the pharmaceutical industry operations. The two "G" compulsory certifications have successfully eliminated a group of backward SMEs in terms of objective effects, standardized the competitive behavior of pharmaceutical production and operations, and initially contained excessive competition in low-level redundant construction, greatly reducing the future of Chinese medicines. The difficulty of quality supervision. At the same time, the pharmaceutical classification management system that has been implemented for several years also classifies a wide variety of listed drugs into two categories, prescription drugs and non-prescription drugs, and divides and treats them according to their respective characteristics in terms of safety and effectiveness, reducing the difficulty of supervision and saving. Regulatory costs.
In terms of information integration capabilities, the merger of institutions at the horizontal level and the unified standards at the vertical level have effectively improved the information integration capabilities of regulatory agencies. Since the establishment of the State Food and Drug Administration in 1998, the State has taken a clear view of the information hurdles between the interministerial departments by translating the supervisory rights between the sanitary administrative department and the pharmaceutical administrative department at the horizontal level. In the enterprise approval, drug review, administrative law enforcement and other major aspects of unified standards, information sharing. At the vertical level, the central government also adopted a series of reforms such as the approval of drug types for approval, the withdrawal of local standards for drugs, and the unification of drug approval numbers, with the intention of eliminating the failure of local government in regulatory information and the quality of drugs at the central and provincial levels. Regulatory information is integrated and shared, and a computer network system covering national bureaus and provincial bureaus is established by launching the integrated application system of the internal network of the drug administration system to achieve network interconnection and interoperability.
In addition, how to strengthen the infrastructure construction of drug supervision under the existing conditions and environment, from the financial funds, personnel team construction and equipment replacement, has become one of the important policy objectives of the regulatory reform since 1998. From the point of view of financial support, as of July 2002, 31 provincial-level drug administrations nationwide implemented a total of 1.12 billion yuan in funds, including 681 million yuan in personnel expenses, 178 million yuan in random inspection funds, and 1.26 yuan in equipment costs. Billion yuan, construction funds 37.19 million yuan, and other supervisory funds 99 million yuan. Compared with the situation before 1998, the proportion of expenditures of funds at the same level of government finances has continuously increased, showing that the status of drug supervision work in the overall work of the government has steadily increased. .
From the point of view of the construction of the talent team, the number of personnel and the professional accomplishments of the drug administration personnel have all improved. In 1991, there were 1,660 drug, drug, and drug supervisor agencies in the country with only 3,466 employees at all levels. There were 1833 drug testing institutes and 19,761 employees. By the end of 2006, the total number of administrative agencies at all levels of the national drug administration system was 2,630, and 1,000 were public institutions. The administrative organs of the drug administration system had issued a total of 45,316 and a total of 12,506 inspectors of various types, of which the provincial drug administration system had a university degree. The above-mentioned personnel accounted for 44%, the prefecture-level drug supervisory system had 35% of the university-educated personnel, and the county-level pharmaceutical supervisory system had 67% of the academic-educated personnel, and the personnel with professional background in pharmacy, medicine, law and chemistry were employed. The ratio increased significantly. Therefore, the quality of the staff of the drug administration system has improved, both in terms of the total number of establishments, academic level, and professional literacy.
By systematically strengthening regulatory independence, improving regulatory information capabilities, and improving regulatory infrastructure, China's pharmaceutical supervisory reforms have implemented a guideline of “supervision, help, and promotion†for ten years to balance the development of the industry. The middle course of quality supervision has basically completed the initial stage of “establishing a basic regulatory system†for the reform of China's drug administration, including a series of basic regulatory systems including GMP and GSP certification, reports on adverse drug reactions, funding for sampled drugs, and so on. Initially established and effectively operated, the quality of medicines has improved: From the point of view of the qualified rate of nationwide drug product sampling inspections, it was only 83.5% in 1997, and it increased to 89% in 1998. The sampling pass rate from 1999 to 2002 was 93% respectively. , 95%, 97%, and 96.9%, showing an upward trend year after year, showing a steady increase in the quality of Chinese medicines. Therefore, the achievements of the Decade of Drug Administration reform cannot be erased.
Five major bottlenecks to deepen reform The strong concern for industrial development – ​​the willingness to oversee conflicts: Due to the strong inertia of the old system, the existing pattern of profit distribution between the government, enterprises, and institutions, as well as inadequate supervision reforms The regulatory authorities are still unable to completely get rid of the embarrassment of promoting industrial development, and once again fall into the quagmire of conflict-free regulatory will. Leading cadres from the pharmaceutical management department have long been engaged in the industry management of the pharmaceutical industry, and their leading work thinking and style have a strong industrial development. Compared with the quality and safety of pharmaceuticals, they are more concerned about How to realize the value-added maintenance of state-owned assets and how to promote the rapid development of China's pharmaceutical industry.
Some local governments regard the pharmaceutical industry as an important carrier for revitalizing local economic development, raising tax resources, and solving social employment. They also provide key protection for pharmaceutical companies within their jurisdiction, and regard the pharmaceutical supervision department as an industry management department for the pharmaceutical industry. Drug regulatory departments have devoted a considerable part of their efforts to attracting investment and serving pharmaceutical companies, relaxing their supervisory responsibilities and forcing grass-roots drug regulatory agencies that are already in a weak position to devote a considerable part of their energy to attracting investment and developing the pharmaceutical economy. On non-regulatory matters. In terms of information collection, some provinces’ drug administration departments are not only responsible for collecting information related to drug quality, but also require the subordinates to collect information data on the development of the pharmacy's economy in the province, so that grass-roots medicine supervisors with The department has devoted considerable attention to the collection of non-regulatory information. All of this has greatly weakened the regulatory independence of grass-roots drug regulatory agencies, which has created a structural conflict in the supervision of pharmaceutical authorities.
The over-competitive industry pattern—high cost of regulatory information: The historical inertia that drew from the traditional model, and the policy factors such as drug price cuts and drug use and medicine led to a decline in the profit rate of the pharmaceutical industry. The establishment of a supervisory system did not Fundamentally changing the development pattern of the over-competitive pharmaceutical industry, the biggest challenge to the quality supervision of pharmaceuticals is to greatly increase the cost of the regulatory authorities in obtaining and identifying real and effective regulatory information. Some increase, but the structural quality problems such as low quality of reports and single source still remain. The regulatory authorities' ability to grasp information on adverse drug reactions is still very limited. The huge loopholes in the design of drug review systems are given to unscrupulous manufacturers in the drug review process. Through tampering with data, stealing data, forging samples, altering processes, and reducing on-site production conditions, etc., the purpose of providing false or even wrong information to the regulatory authorities is to achieve the purpose of defrauding the regulatory authorities for approval; Landmarks in the national standard "movement, some Industry gradually to entice regulatory authorities through fraudulent way arbitrarily reduce the standard way that the nature of the sport began to be alienation.
The inertia of the command-planned economy—a highly administrative style of supervision: Although the mandatory implementation of GMP and GSP certification in pharmaceutical quality supervision in China is entirely reasonable, it is completely enforced through hard administrative measures, showing that the regulatory authorities are The administrative process is highly dependent on the regulatory process; in some places, the drug administration department stipulates that a certain distance cannot open two pharmacies at the same time, which is suspected of serious offsides; and frequent launches of various special rectification campaigns are incomplete. According to statistics, from 1999 to 2004, in the field of drug market regulation alone, the State Drug Administration Department has launched 10 special rectification campaigns, which essentially reflects the inability to establish institutionalized long-term mechanisms during the drug quality supervision process. The reality of inadequate regulatory capacity.
There is a lack of regulatory power structure that restricts and participates in rent-seeking regulatory corruption: a by-product of centralized reform is the high concentration of regulatory power in the drug registration department and officials, which inevitably leads to a series of regulatory corruption. In essence, the root cause of the series of corruption brought about by the reform of drug administration lies in the fact that after the central authorities have recovered important regulatory power, under the lack of an authoritative structure of effective monitoring agencies, strong drug regulatory power has made drug regulatory policy Both design and implementation cannot accept other effective restrictions from departmental powers and active participation in social rights, resulting in the consequences of “departmentalization of state powers†​​and “personalization of departmental powersâ€. In addition, the arduous task of drug supervision and weak drugs The gap between regulatory capabilities provides space for regulatory corruption, and the highly professional and over-competitive nature of the industry provides the possibility of regulatory corruption.
Conflicts between local developmentism and regulatory totalitarianism - still weak regulatory infrastructure construction: Since the drug surveillance system after the vertical management reform no longer belongs to the local local government sequence, the provincial governments no longer have financial appropriations for the drug surveillance system. The statutory obligations and supervision of drug safety have also started to fade away from the work appraisal system of local governments under the provincial government, and have turned into a potential conflicting regulatory goal with the general goal of local developmentism. With the exception of a few economically developed provinces on the eastern coast, most of the central and western provinces have very limited financial resources. Basically, they cannot fully allocate the required financial funds to the drug surveillance system after the implementation of the vertical management system. Effectively improving the technical supervision and inspection capabilities of the drug regulatory agencies has directly led to the weakening of the pharmaceutical supervision infrastructure in the provinces of the central and western regions under the developmental system, which has not been able to achieve significant improvement.
In summary, the five major bottleneck factors in the reform of the Drug Administration decade are its historical and institutional roots in the strong inertia of the planned economy and the development-oriented system, which has led to the emergence of partial regulatory failures, which has seriously constrained the reform of the pharmaceutical supervision system. The stage is to develop a quality supervision stage.
Towards Quality Supervision – The direction of China's drug regulatory reforms From the perspective of the process of establishing a national regulatory government, it generally takes a process from the initial stage of the regulatory system to the stage of high-quality regulation. In order to effectively improve the quality of supervision, in the future China's drug administration reform should focus on breakthroughs in the above five bottlenecks to advance in depth:
First, the drug administration department should not only re-position and reflect on the post-development supervision model of “supervising, helping, and promoting†from the actual political slogans. Local governments at all levels should separate the functions of promoting the development of the pharmaceutical economy and strengthening the management of the pharmaceutical industry from the drug regulatory agencies and assign them to economic development departments such as the National Development and Reform Commission or industry associations. They can no longer attract investment, develop the pharmaceutical economy, and establish pharmaceuticals. Markets, providing services for pharmaceutical companies, collecting information and information on the pharmaceutical industry, and other non-quality regulatory functions are included in the daily work of drug regulatory agencies.
Secondly, the drug regulatory authorities should focus their information acquisition and identification on the quality and safety of drugs themselves, including the true degree of declaration data in the drug registration process, whether the raw materials and accessories used in the production process and the production process are in compliance with GMP regulations, and business operations. Whether the transportation and sales of pharmaceuticals meets the GSP specifications and reports of adverse reactions in the use of links, the drug regulatory departments at different levels should establish an effective regulatory information division system based on the characteristics of the pharmaceutical industry chain: the State Bureau should focus on regulatory information The development, registration and production of pharmaceuticals should be carried out on the upstream and downstream chains of multiple industries so as to contain the practices of falsifying and cutting corners at the source; the local supervisory authorities should focus on improving the monitoring system for adverse drug reactions and the monitoring of downstream processes in the industries such as business use. , to strengthen the risk supervision of drug listing.
Third, in addition to traditional administrative measures, drug regulatory agencies can also use economic incentives and penalties, licensing systems, technical standards, information provision, property rights, subsidies, performance standards, and other tools in regulatory practices, making regulatory agencies Instead of relying solely on rigid regulatory measures, it will enable some flexible regulatory measures to achieve regulatory policy goals.
Fourth, from the perspective of balance of power, the next step of reform should be to split the overly centralized drug registration authority and implement the working mechanism of drug registration acceptance, technical review, and administrative approval separation, and strengthen technical review. The weight of the decision in the final administrative approval. The plan for the reform of the food and drug administration to the reform of the health sector reflects the central government’s intention to strengthen checks and balances by means of restricting power by means of power. At the same time, the National People’s Congress, the State Council, the Central Commission for Discipline Inspection, and the procuratorate departments should also strengthen the drug regulatory agencies. Inquiries and monitoring efforts, but can not go to the old road of decentralization. From the point of view of rights restriction, the drug administration department should actively foster relatively independent industry associations and consumer organizations, and empower some of the non-core regulatory powers through relatively empowering social organizations. With the help of the industry's self-regulatory and social supervisory powers to achieve regulatory objectives and to break the monopoly of the supervisory authority's complete monopoly of regulatory power, it can also greatly reduce the risks and costs of the regulatory authorities.
Finally, the key to effectively resolve the contradiction between local developmentism and regulatory centralism is to continue to implement unfinished vertical management reforms and implement a unified national vertical management of the drug surveillance system, instead of simply returning to the “local government’s overall responsibility†block management. era. Although the institutional reform of the drug surveillance system was replaced by the health department, the author believes that the drug surveillance system should still maintain a certain degree of relative independence. The national vertical management of the drug administration system can relatively separate the responsibility of the industry development and quality supervision, and completely supervise the drug regulatory function into the central government, which can not only better eliminate local protectionism in drug supervision, but also lead to The conflict between the development of local governments and their supervisory role will also help improve the overall quality of the drug administration team. Under the favorable environment in which the country puts food and drug supervision under the “Eleventh Five-Year Planâ€, whether it is the central government or local governments at all levels, it should increase financial input to the drug regulatory infrastructure construction in a timely manner and change the current drug surveillance system. Due to insufficient budgetary funds, it is necessary to pass through the extra-budgetary revenues such as administrative examination and approval, law enforcement fines, and other extrabudgetary revenues to make up for the abnormal fund-raising structure, thereby effectively improving the situation in which the local drug regulatory infrastructure is still weakened.
The ten-year history of China's drug administration reform focused on the microcosm of the construction of China's regulatory government. It fundamentally shows that after experiencing a highly centralized planned economic system and a relatively out-of-standard market economy, the government has strengthened the economy. The basic process and logic for effective supervision of order and product quality. The reform plan that the Food and Drug Administration changed to be managed by the health department is another beneficial attempt in such a basic logical process. Changes in the administrative structure can create certain conditions for the reform of the regulatory system, but it does not guarantee the realization of quality supervision at a glance. No matter how the specific institutional setup changes, the general trend of strengthening the function of drug safety supervision will only be strengthened and will not be weakened. We sincerely hope that after undergoing a series of trials and tribulations, the reform of China's drug administration will be able to move from the initial stage of "establishing a regulatory infrastructure system" to fostering a higher level of "quality supervision" mode in the following new decade. At the stage, it truly became the patron saint of Chinese people's health.
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