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国务院关于进一步加强药品管理工作的紧急通知 URGENT CIRCULAR CONCERNING FURTHER STRENGTHENING THE ADMINISTRATION OF MEDICINE

2006-05-16 16:43   我要纠错 | 打印 | 收藏 | | |

国发(1994)53号
(September 29, 1994)
颁布日期:19940929  实施日期:19940929  颁布单位:国务院

  Medicine is a special kind of commodity that has considerable bearing on the lives and health of the people. Therefore, strengthening medical administration, guaranteeing the quality of medicine and ensuring people convenient, timely, safe and effective application of medicine are important tasks which safeguard the people's health, maintain social stability and ensure a successful progress of economic construction and the smooth conduct of reform and opening. Since the reform and opening, the cause of China's medicine has undergone a rapid development. Nonetheless, in order to further strengthen the administration of medicine, the state has enacted the “Law of the People's Republic of China on the Administration of Medicine” (hereinafter referred to as the “Law on the Administration of Medicine”),formulated a series of related administrative regulations and worked out a set of documents having legislative character. And forces have, time and again, been organized to wage concentrated crackdown on criminal activities in respect of the manufacture and sale of false and inferior medicine, resulting in certain effectiveness. We must be aware, however, that problems still persist regarding the administration of medicine, some of which are rather serious. The outstanding expression is the fact that criminal activities involving the illegal manufacture and sale of false and inferior medicine has not been eliminated despite repeated prohibitions thereof and in some areas numerous kinds of false and inferior medicine are produced and sold on a large scale. Such criminals have lost sight of social virtue because of their unscrupulous commitment to illicit profits, thus bringing about serious consequences. Some districts and departments, in an attempt to grab self-interest, have broken the law on administration of medicine, and have competed for the establishment of medicine-producing and selling enterprises as well as trade fair markets for medicine. And as a result, disorder has arisen in respect of medicine production and sales, and malpractices including bribery, demand for bribery and illegal rebates have prevailed in the purchase and sales of medicine. Moreover, advertisements of medicine in violation of law filled with outrageous overstatements have gone unchecked, and development of new medicines has not been sufficiently protected. Criminal activities in producing and selling false and inferior medicine have seriously endangered people's lives and health, impaired the nation's interests, disturbed the economic order, corrupted social morality, produced adverse effect on social stability and defamed the reputation of the Party and government, and to these people from various circles have reacted strongly. Therefore, the time has come when great efforts must be made to find a solution for them. Thus following urgent circular on related matters is hereby publicized:

  1. The people's governments and departments at various levels should raise the level of understanding and practically strengthen leadership regarding the administration of medicine.

  One of the important reasons that criminal activities in producing and selling false and inferior medicine has not been eliminated despite repeated prohibitions is the fact that some local governments and departments have not understood the significance of medicine as a special kind of commodity in relation to the people's lives and health, under a mistaken idea that administration of medicine may be slackened when the establishment of socialist market economic system is under way. Some districts and departments have, for their own partial and local interests, gone so far as to protect the criminal activities in producing and selling false and inferior medicine.

  The people's governments and related departments at various levels shall, with a sense of high responsibility for the country and people and an overall view of the situation, unify the understanding of the significance of strengthening administration of medicine, adopt effective measures to implement seriously laws and administrative regulations on administration of medicine, strengthen supervision and administration as well as macro-control by the state of medicine production and sales, so as to rectify and standardize production and sales thereof and, in combination with the struggle against corruption, to investigate and deal with cases involving violation of laws and discipline, with a view to the establishment of a unified, open, competitive and orderly system for medicine production and sales.

  The people's governments at various levels should establish a system whereby status of the targets set for the government leaders pertinent to the administration of medicine within their terms of office can be evaluated. The principal responsible comrades of the people's governments at various levels should practically bear the leadership's responsibility for the administration of medicine within their respective regions, and the leaders of the governments and relevant departments of the areas where disorder exists in the administration of medicine shall, in accordance with law, be investigated for responsibility.

  2. Effective measures should be taken to significantly strengthen law enforcement and administration of medicine production and sales.

  Presently, the people's governments at various levels and relevant departments should attach great importance to the performance of following work:

  (1) Rectify and standardize the production and sales of medicine enterprises and individual industry and commerce.

  In the light of the present situation which involves excessive medicine producing and selling enterprises and disorder, the people‘s governments at various levels and the departments in charge of medicine production and sales, the departments for the administration of health and the departments for the administration of industry and commerce, shall, according to law, strictly enforce procedures for examining the conditions and for the examination and approval of the establishment of medicine producing and selling enterprises. In case of failure to conform with the conditions for setting up or with the procedures for examination and approval, the departments in charge of medicine production and sales, the departments for administration of health and the departments for administration of industry and commerce shall not grant the approval for setting up. Those enterprises which are already operating but have not satisfied the conditions for examination shall be banned according to law.

  Health administration departments shall organize investigations into various types of medicine produced by existing production enterprises, and regarding medicine which are found to be producing unproven effectiveness, giving adverse reactions or endangering the health of the people for other reasons, the reference number for approval thereof shall be timely withdrawn. The department in charge of medicine production and sales, when processing the applications for establishing medicine-producing enterprises, shall devote particular attention to ascertaining whether the types of medicine to be produced are new medicines or the types of important medicine the country is to develop, and shall grant no approval for such enterprises without the new medicine being approved by the department for administration of health under the State Council or whose medicine is not the type of important medicine the country is to develop. With regard to the medicine which is reproduced at low level, directives shall be given to the enterprises for them to make timely adjustment of the structure of products. Enterprises engaged in wholesale distribution of medicine shall be examined to determine whether they have the ability to supply within 24 hours the types of medicine listed in the national catalogue for basic medicine, and the ability to supply medicine to specially designated regions or units appointed by the departments in charge of medicine production and sales under the local people's governments at the county level or above. Wholesale of medicine enterprises which do not possess the ability to supply the medic inereferred to above shall be banned from engaging in the wholesale business according to law.

  Individual industry and commerce may, according to law, apply for retail business, but shall not engage in production and wholesale distribution (except the wholesale of traditional Chinese herbs in the specialized markets for traditional Chinese herbs approved according to law)。

  All those engaged in medicine production must, according to the legal procedures, obtain the “qualification certificate for medicine-producing enterprise”, the “permit certificate for medicine-producing enterprise” and the “business license”。 All those engaged in the wholesale and retail sale of medicine must, according to the legal procedures, obtain the “qualification certificate for medicine-selling enterprise”, the “permit certificate for medicine-selling enterprise” and the “business license”。 All those already in operation without the mandated certificates and licenses must be banned according to the law.

  Applications for setting up medicine-producing enterprises or medicine-selling enterprises for wholesale, must be examined and certified by the departments in charge of the production and sale of medicine under the people's governments of the provinces, autonomous regions and municipalities under the Central Government that issue the “qualification certificate for medicine-producing enterprise” or the “qualification certificates for medicine-selling enterprise”。 Then they may apply to the department for the administration of health at the same level for the “permit certificate for medicine-producing enterprise” or the “permit certificate for the medicine-selling enterprise”。 Without the “qualification certificate for medicine-producing enterprise”, or the “qualification certificate for medicine-selling enterprise” issued by the department in charge of the production and sale of medicine upon examination and agreement, the department for the administration of health shall not accept the application. Without obtaining the “qualification certificate for medicine-producing enterprise”, the “permit certificate for medicine-producing enterprise” or the “qualification certificate for medicine-selling enterprise”, the “permit certificate for medicine-selling enterprise”, the department for the administration of industry and commerce shall not check and issue the business license.

  The applications for retail of medicine business by enterprises, or individual industry and commerce, shall be examined by the departments in charge of the production and sale of medicine under the people's governments of the autonomous prefectures, cities or counties, according to the needs for medicine and the program for the retail of medicine network within their regions, and if agreed upon examination, the “qualification certificate for medicine-selling enterprise” shall be issued. The retail of medicine enterprise, and the individual industry and commerce, shall take the “qualification certificate for medicine-selling enterprise” to the departments for the administration of health at the same level for application and, after obtaining the “permit certificate for medicine-selling enterprise”, may apply to the departments for the administration of industry and commerce for the issuance of the business license.

  Certificates and licenses that have not been issued according to the procedures for examination and approval referred to above by the departments in charge of the production and sale of medicine, the departments for the administration of health and the departments for the administration of industry and commerce, become invalid, and the losses caused therefrom shall be compensated by the issuing departments according to law, and the persons in charge who are directly responsible and the persons directly responsible shall be investigated for responsibility.

  (2) The order for medicine production and sale should be rectified and standardized, and the administration of the sale of medicine shall be strengthened according to law.

  Those who have not obtained, according to law, the “qualification certificate for medicine-producing enterprise”, the “permit certificate for medicine-producing enterprise” or the “qualification certificate for medicine-selling enterprise”, the “permit certificate for medicine-selling enterprise” and the business license, shall not be engaged in the production and sale of medicine. The units and individuals engaged on their own decision in the production and wholesale of medicine shall be resolutely banned. Enterprises engaged in the production and wholesale distribution of medicine shall not be contracted by individuals for business.

  Medical institutions and medicine-selling enterprises must purchase medicine from enterprises that have obtained lawful qualifications for medicine production and sales, and are strictly prohibited from purchasing medicine from unlawful dealers.

  The supply of medicine to medical clinics in rural areas shall be the responsibility of the medicine wholesalers and the township's hospital entrusted by the wholesalers jointly appointed by the departments in charge of medicine production and sales and those for the administration of health under the local people's governments at the county level.

  The preparations manufactured by medical institutions are limited to those needed for clinical purposes and scientific research conducted by the units themselves, and which are not supplied or inadequately supplied in the markets. The sale in a disguised manner of such products shall be strictly prohibited. Medical institutions shall not, in any disguised manner, engage in the wholesale business.

  Fair competition shall be practiced in the purchase and sale of medicine between the production and management of medicine enterprises and medical institutions, and in purchases and sales, malpractices such as rebates, or bribery and requesting bribes are prohibited.

  Departments responsible for the administration of health shall strictly examine the contents of publicity materials and advertisements and in coordination with the relevant departments, shall, according to law, punish illegal acts such as advertising medicine in violation of regulations, unfounded propaganda regarding effectiveness and other acts which mislead patients.

  (3) The specialized markets for the traditional Chinese herbs should be rectified and standardized.

  The state prohibits the setting up of trade fair markets for medicine, except specialized markets for traditional Chinese herbs, and prohibits in the specialized markets for traditional Chinese herbs the sale of traditional Chinese herbs and ready-made medicine, tablets of Chinese herbs, medicine of chemical raw materials and its preparations, antibiotics, biochemical medicine, radiate medicine, serum vaccine, blood products and diagnostic medicine of which sales are restricted as stipulated by the state.

  The specialized markets for traditional Chinese herbs must be set up in selected principal producing or distributing places of traditional Chinese herbs according to overall plans drawn up by the department under the State Council in charge of production and sales of medicine, and must also be examined and approved by the department in charge of the production and sales of medicine, the department for the administration of health and the department for the administration of industry and commerce under the State Council. The local people's governments at various levels and the other departments are not authorized to examine and approve the establishment of specialized markets for traditional Chinese herbs.

  The existing specialized markets for traditional Chinese herbs shall be rectified, and the criteria shall be formulated by the department in charge of the production and sales of medicine, the department for the administration of health and the department for the administration of industry and commerce under the State Council. Specialized markets for traditional Chinese herbs which have already been set up but are not in compliance with the criteria shall be closed without exception. Any other trade fair markets for medicine except specialized markets for traditional Chinese herbs that have been set up without proper authorization shall be banned according to law by the local people's governments.

  Traditional Chinese herbs being sold in trade fair markets for agricultural products shall be supervised strictly by the department for the administration of health. Those who sell types of traditional Chinese herbs on their own decision that are prohibited by the state from being sold and the medicine other than the traditional Chinese herbs without certificate in trade fair markets for agricultural products in violation of the “Law on the Administration of Medicine” shall be investigated and punished by the relevant departments according to the provisions of the “Law on the Administration of Medicine”。

  (4) The protection for the intellectual property rights for medicine shall be strengthened, and enterprises are encouraged to research in and develop new medicine.

  The department for administration of health and the department in charge of the production and sales of medicine under the State Council, shall develop practical plans for encouraging enterprises, scientific research units, universities and colleges to promote research and develop new medicine.

  The “Regulations on the Protection of the Types of Chinese Medicine” issued by the State Council shall be further implemented in various places. The types of Chinese medicine already listed for national protection shall not be imitated and manufactured by enterprises without the protection certificate. The relevant departments and examining and appraising organs shall conscientiously do a good job to protect the types of Chinese medicine in order to promote development of Chinese medicine.

  3. There should be an intensified crackdown on criminal activities involving the production and sales of false and inferior medicine. In addition, investigations should be conducted into cases involving violations of law and discipline with regard to the production and sales of false and inferior medicine. These activities shall be considered of great importance with regard to combating corruption.

  In order to check resolutely law-breaking and criminal activities in producing and selling false and inferior medicine, local people's governments at various levels and the relevant departments, shall carry on further blows on the law-breaking and criminal activities in producing and selling false and inferior medicine. In cracking severely the law-breaking and criminal activities in producing and selling false and inferior medicine, they should strictly enforce laws and intensify law enforcement regarding these issues. The national and local coordinating institutions for “striking the false” at various levels shall organize the relevant departments of health, medicine, administration of industry and commerce, technical supervision and public security in investigating into and dealing with the law-breaking and criminal activities in producing and selling false and inferior medicine, which shall be made an important task for “striking the false”。 The criminal elements producing and selling false and inferior medicine shall be resolutely punished according to the “Decision of the Standing Committee of the National People's Congress on Punishments for Crimes in Producing and Selling False and Inferior Commodities”。 Influential and typical cases shall be singled out for exposure.

  The people's governments at various levels shall treat cases of producing and selling false and inferior medicine and other instances in violation of law and discipline as important issues to be addressed in combating corruption. There fore, supervisory departments of the people's governments at various levels shall, according to the provisions of the “Regulations of the People's Republic of China on Administrative Supervision”, exercise supervision over the implementation of law and administrative regulations by staff workers of the departments for administration of health, the departments in charge of the production and sales of medicine, the departments for the administration of industry and commerce and the departments for technical supervision. Those who have abused their power, been negligent in their duties, acted illegally by deception for personal interests and acted in violation of law and discipline through other means, must be dealt with severely according to law. For those engaged in providing unjustifiable protection and support for criminal activities in producing and selling false and inferior medicine for the interests of their own districts or departments and causing serious losses to the people, the leaders of the local governments and the relevant departments as well as the persons in charge and the persons directly responsible must be investigated for responsibility according to law. And if the case is so serious as to constitute a crime, the offender must be investigated for criminal responsibility according to law.

  4. The harmonious cooperation among the departments of the governments shall be strengthened, and the administration of medicine shall be raised to a higher level.

  The administration of medicine is a complicated and systematic project, and the relevant departments of the people's governments at various levels must jointly do a good job in the administration of medicine according to the division of duties, by shouldering their respective duties, and through mutual support and full cooperation.

  The departments for the administration of health at various levels are the government's functional departments that exercise supervision and administration of medicine. The people's governments at various levels and the relevant departments shall fully support and assist the departments for the administration of health in exercising, according to law, its function with respect to its responsibility to supervise and administer medicine.

  The offices of the State Administration of Medicine and the State Administration of Traditional Chinese Medicine and Pharmacy are the departments of the State Council in charge of medicine production and sales, and the local departments in charge of medicine production and sales at various levels shall, according to law, exercise the governmental function of administration of medicine production and sales. The medicine-producing and selling enterprises shall, except otherwise provided by the state, be taken into the scope of the administration of the medicine industry, irrespective of the forms of ownership and the subordinating relationship. The people's governments at various levels and the relevant departments thereof shall fully support and assist the departments in charge of medicine production and sales in the administration of medicine according to law.

  The administration of industry and commerce and the departments for technical supervision and public security, shall strengthen the administration of medicine markets according to their respective duties along with the departments for the administration of health and the departments in charge of medicine production and sales.

  In case of disorder in the administration of medicine caused by quarreling, leaving duties and responsibility for others and undermining each other's work, the leaders of the relevant administrative departments shall be investigated for responsibility according to law.

  The departments for the administration of health and the departments in charge of medicine production and sales must, according to the provisions of the Central Committee of the Communist Party of China and the State Council, put into practice the separation of government from enterprises, and shall not use administrative rights to interfere with the enterprises' production and sales. All malpractices applied in purchasing and selling medicine must be resolutely stopped. Fairness and justice, honesty and authority in official duties of the administrative justice departments and the departments in charge of the industry shall be maintained.

  The State Council shall organize the relevant departments in the performance of an in-depth study to revise and perfect the law and regulations on the administration of medicine, further put in order the administrative system for medicine, reform the administrative system for the price of medicine, perfect the supervising system for the quality of the medicine, further raise the country's level for the administration of medicine and promote continued, fast and healthy development of the country's medicine.

  The people's governments of the provinces, autonomous regions, municipalities under the Central Government and relevant departments of the State Council shall, according to the requirements of this Circular, take practical measures to carry out an overall rectification in respect of the present situation regarding the administration of medicine within their regions and departments, and submit reports on the rectification to the State Council before March 1, 1995.

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