Explanation of "Measures for the Implementation of the Drug Administration Law of the People's Republic of China"
On January 7, 1989, the State Council approved the "Implementation Measures of the Pharmaceutical Administration Law of the People's Republic of China" (hereinafter referred to as the "Implementation Measures"), which was promulgated and implemented by the Ministry of Health on February 27 of the same year.
1. The purpose and significance of promulgating the "Implementation Measures"
The "Implementation Measures" are based on the summarization of more than three years of work experience in implementing the "Drug Administration Law", in response to the problems in law enforcement, in order to ensure the quality of drugs, improve the efficacy of drugs, ensure the safe and effective use of drugs, and protect the health of the people. Better implement the "Drug Administration Law", strictly ensure that "the law must be followed, law enforcement must be strict, and violations must be investigated", and more specific and clear basis for law enforcement will be promulgated and implemented.
In the context of deepening reforms, improving the management system, and strengthening drug management according to law, the promulgation and implementation of the "Implementation Measures" is of great significance. The "Implementation Measures" will further institutionalize law enforcement.
The "Implementation Measures" particularly emphasizes the supervisory functions of the health administrative department, and specifies the specific responsibilities of the health administrative department's drug administration and drug inspection agencies, the establishment of drug supervisors, and the forms and procedures of supervision and management. These clear regulations will play an important guiding and promoting role for the pharmaceutical policy and drug inspection agencies of the health administrative department in the future to strengthen supervision and management, strengthen institutional construction and improve the quality of personnel. The "Implementation Measures" have made institutional provisions on the approval of licenses, the approval of new drugs, and the management of drug production and operation enterprises. This will surely speed up the legalization process of drug management in my country and further deepen the reform of drug supervision and management. Vigorously promote the development of my country's pharmaceutical production and operation and medical and health services.
2. Background of the "Implementation Measures"
On July 1, 1985, the "Pharmaceutical Administration Law of the People's Republic of China" came into effect. Under the leadership of the State Council and local people's congresses and governments, the health, medicine, industry and commerce, public security, justice, and disciplinary inspection departments cooperated closely and worked in unity and impartiality. Law enforcement, loyal to their duties, done a lot of work, achieved great results, and made important contributions to my country's drug supervision and management.
1. Improve the legal system and create a new situation in drug supervision and management
In accordance with the requirements of the "Drug Administration Law", a series of regulations have been formulated, among which are the "Administrative Measures for Narcotic Drugs", "The Regulations on Drug Production Quality Management", "New Drug Approval Measures" and "Several Supplements on New Drug Approval Management" Regulations, "New Biological Products Examination and Approval Measures", "Notice on Adjusting Charge Standards for Drug Approval and Supervision and Inspection", "Notice on Trial Implementation of National Standards for the Establishment of Local Drug Inspection Institutes and Drug Supervisors at Various Levels", "Administrative Measures for Drug Advertising" , "Regulations on the Protection of New Drugs and Technology Transfer", "Regulations on the Registration, Import and Clinical Trials of Foreign Drugs in China", "Regulations on the Work of Drug Supervisors", and "Regarding Economic Penalties for Cases of Manufacturing and Selling Counterfeit Drugs and Substandard Drugs" "Notice", "Adverse Drug Reaction Monitoring and Reporting System". In addition, the State Council also approved the release of the "Measures for the Administration of Psychotropic Drugs," the "Measures for the Administration of Toxic Drugs," and the "Measures for the Administration of Radioactive Drugs." Various localities have also formulated some local laws and regulations accordingly to gradually improve the legal system of drugs. People's congresses and governments at all levels carry out propaganda through radio, television, newspapers and other forms. Many provinces and cities also hold exhibitions of counterfeit and inferior medicines for legal education.
2. Issuing the "Three Certificates" to rectify pharmaceutical production and operation enterprises and hospital preparations
There are more than 63,000 pharmaceutical production and operating companies and hospital preparation rooms across the country that have undergone inspections, acceptance checks and "licenses". In the work of issuing "licenses", various regions have accumulated a lot of good experience. After the "three certificates" were issued, the pharmaceutical production and operation enterprises and the hospital preparation room were reorganized, and the chaotic situation of the past pharmaceutical production and operation was basically reversed.
3. Investigate and deal with counterfeit and inferior drugs, and severely crack down on drug dealers
In 1985, the Ministry of Health issued the "Emergency Notice on Seriously Investigating and Prosecuting Counterfeit Drug Cases", and in 1986 it issued the "Notice on Investigating and Prosecuting the Second Batch of Fake and Inferior Varieties of Chinese Medicinal Materials". In the drug operation, over 11,000 cases of manufacturing and selling counterfeit and inferior drugs have been investigated and dealt with nationwide over the past few years, and counterfeit and inferior drugs worth a total of 180 million yuan have been investigated and prosecuted. The criminals have been brought to justice and eliminated. Many hidden dangers endangering people's health and safety. The large-scale inspections of the quality of medicines carried out in various places have effectively controlled the proliferation of various counterfeit and inferior medicines.
4. Strengthen the sampling of drugs, and the quality of drugs is on the rise
After three years of random inspections, the effectiveness of supervision has been brought into full play, which has promoted the improvement of drug quality and accelerated the transformation of drugs from post-event management to pre-management.
5. Strengthen the supervision and management of imported drugs to prevent inferior foreign drugs from harming the health of our people
Since the implementation of the "Drug Administration Law", the management of imported drugs has been strengthened, the "Imported Drug Administration Measures" have been formulated, the "Catalogue of Imported Drugs" has been compiled, and the "Imported Drug License" has been issued. According to incomplete statistics, in three years, my country's nine port drug control institutes tested 10,300 imported western medicines, of which 381 were unqualified, and recovered more than 20 million US dollars of national property. The various port drug control offices in my country have enriched their technical capabilities, purchased and updated equipment, and insisted on strict inspection of imported drugs batch by batch. Each port office has initially formed a rigorous information exchange and quality control network.
6. Strictly manage special drugs and rectify blood products
According to the "Drug Administration Law": "The state implements special management methods for narcotic drugs, psychotropic drugs, toxic drugs, and radioactive drugs." Over the past few years, a complete management system has been formed in the cultivation, production, supply and use of narcotic drugs. Ensure that narcotic drugs are only used for medical research.
In 1985, my country participated in the "Single Convention on Narcotics of 1961" and the "Convention on Psychotropic Substances of 1971", and actively participated in the international narcotics control work. In 1987, the Office of Narcotics Management and Anti-drug Coordination Conference composed of three departments and one department was formally established. Daily work has strengthened the management of narcotic drugs.
7. Work hard on new drug approval and drug standards
According to the provisions of the "Drug Administration Law", my country has implemented new drug approval measures on October 1, 1985, stricter the standards for new drug approval, successively organized a new drug review committee, established a drug review office, and established 30 A number of clinical pharmacology bases for western medicine have drafted guidelines for clinical research of 66 drugs. After several years of work, a new order for new drug approval has been initially established. By the end of 1988, the Ministry of Health had standardized production and clinical research of 193 new drugs, of which 126 were produced or trial-produced, and 67 were undergoing clinical trials. The Fifth Pharmacopoeia Committee was established, a new charter was adopted, the standard work management method was revised, and a compilation plan for the 1990 Pharmacopoeia was proposed. The Pharmacopoeia organized the compilation of the 1985 edition of the pharmacopoeia supplementary edition and the 1985 edition of the pharmacopoeia annotation selection.
8. Strengthen the construction of law enforcement teams and improve the supervision and guarantee system
Since the implementation of the "Drug Administration Law", more than 300 prefectural (city)-level drug control centers and more than 1,500 county drug control centers have been established across the country. A four-level drug inspection network at the central, provincial, prefecture (city) and county levels was initially formed, and 32.4 million yuan was used to equip new equipment. Drug administration and drug inspection personnel have generally increased across the country. By holding different levels and types of training courses, the quality of the law enforcement team has been improved, and the work needs have been met. Through the above work, combined with three years of work experience, in accordance with the provisions of Article 59 of the "Drug Administration Law", the health administration department of the State Council formulated the "Implementation Measures" and submitted it to the State Council, and issued a letter from the State Council on January 7, 1989 [ 1989] Approved No. 3, issued and implemented by the Ministry of Health on February 27.
3. The main content of the "Implementation Measures"
The "Implementation Measures" has ten chapters and 57 articles, which are the supporting administrative regulations of the "Drug Administration Law" and the statutory interpretation of the "Drug Administration Law".
1. The basis for the formulation of the "Implementation Measures", the scope of use, and the guidelines and policies for drug development
The General Provisions of Chapter 1 of the "Implementation Measures" stipulate that this law is applicable to all relevant drug production, operation, use, inspection, scientific research units and individuals, and clarified that the policies and guidelines for drug development must put social benefits in the first place to protect the people Healthy body.
2. Drug supervision and management responsibilities
Articles 4 to 10 of the "Implementation Measures" stipulate that the competent department of national drug supervision and administration is the health administration department of the State Council, and stipulates that its main responsibilities have seven aspects. It also stipulates the establishment and tasks of drug inspection institutes. The method of confirmation, procedures and responsibilities for performing duties of drug supervisors are also stipulated.
3. New drug approval and drug approval number
Article 16 of the "Implementation Measures" stipulates that the new drug approval measures shall be formulated by the health administration department of the State Council. Article 20 stipulates that the health administrative department of the State Council and the health administrative department of provinces, autonomous regions, and municipalities directly under the Central Government may establish a drug review committee, which is composed of medical and pharmaceutical experts in medical treatment, scientific research, production, and teaching. Article 24 stipulates that the approval document number of drugs shall not be changed within five years, but the approval document number of drugs whose production has been suspended for more than three years shall be invalidated. The provisions of Article 25 strengthen the management of listed drugs and prevent those harmful to people’s health. The approval number of the drug shall be revoked.
4. Management of pharmaceutical manufacturing enterprises
Articles 26 and 27 of the "Implementation Measures" stipulate that the state shall implement the "Pharmaceutical Production Quality Management Standards", and the expansion and reconstruction of new pharmaceutical manufacturing enterprises and existing enterprises must meet the requirements of this "standard". The "Implementation Measures" stipulate that pharmaceutical production enterprises should have full-time technical personnel and skilled workers, and set requirements on the business level of the factory directors and responsible persons of relevant departments responsible for the production technology and quality of pharmaceuticals. The factory buildings, facilities and sanitary environment are required to be clean and tidy. Those who prepare infusions and powder injections must have ultra-clean conditions.
Article 31 of the "Implementation Measures" stipulates the special requirements of Chinese medicine factories.
The "Implementation Measures" also set strict regulations on production records and inspection records, raw materials and auxiliary materials required for the production of drugs, and containers and packaging materials that directly contact drugs. Those that do not meet the drug standards shall not leave the factory.
5. Pharmaceutical business management
Article 36 of the "Implementation Measures" stipulates that pharmaceutical business enterprises should have full-time pharmaceutical technicians, and put forward corresponding requirements for the level of full-time pharmaceutical technicians in pharmaceutical wholesale enterprise quality inspection agencies and pharmaceutical retail enterprises. Non-pharmaceutical technicians who are recruited and transferred to engage in drug preparation, purchase, storage, and sales must be trained in pharmaceutical knowledge.
The "Implementation Measures" particularly emphasizes that the acquisition and sale of drugs must establish and improve strict quality inspection and storage acceptance, maintenance in storage, and delivery verification and issuance systems. The inspection and acceptance content includes: the name of the drug, the manufacturer, the production batch number, the certificate of conformity, the approval number, the registered trademark, the packaging, and the appearance quality of the drug. The packaging of Chinese medicinal materials must be checked. __
6. Preparation management of medical units
The "Implementation Measures" stipulate the conditions of the medical unit that prepares the preparations. The preparations must strictly implement the operating procedures, quality inspections and sanitation systems. Each batch of preparations must have detailed and complete records. There must be a corresponding drug inspection room. The quality of the preparations must be inspected. After being qualified, the drug inspection room will issue a certificate of preparation for clinical use with a doctor’s prescription. The preparation of preparations by medical units is limited to the clinical and scientific research needs of the unit, and cannot be sold on the market or sold in disguise. The pharmacy department (room) and isotope room (nuclear medicine room) of medical units are statutory units for preparing and supplying drugs, and other departments are not authorized to prepare and supply drugs.
The "Implementation Measures" stipulates that administrative penalties shall be decided by the health administrative department at or above the county level, and a written penalty notice shall be issued. All the proceeds from the fine shall be turned over to the state treasury.
The "Implementation Measures" clearly stipulates the specific boundaries of warnings, fines, and severe administrative penalties. For drug inspection staff and drug supervisors who use their powers to practice favoritism or accept bribes, administrative sanctions or criminal liabilities shall be imposed according to the severity of the circumstances.
8. Strengthen the management of specially managed drugs
Article 55 of the "Implementation Measures" stipulates the labeling of narcotic drugs, psychotropic drugs, toxic drugs, radioactive drugs and drugs for external use in order to strengthen the understanding of special drugs and strengthen their management
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