(1) Pharmaceutical production and business license system
According to the provisions of the Drug Administration Law, the establishment of a pharmaceutical production enterprise must be approved by the pharmaceutical supervisory and administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government where the enterprise is located, issued with a Pharmaceutical Production License, and registered with the administrative department for industry and commerce by virtue of the Pharmaceutical Production License. No drug may be produced without a drug production license.
According to the provisions of the Drug Administration Law, the establishment of a pharmaceutical wholesale enterprise must be approved by the pharmaceutical supervisory and administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government where the enterprise is located, and a Pharmaceutical Business License shall be issued; To set up a pharmaceutical retail enterprise, it must be approved by the local pharmaceutical supervisory and administrative department at or above the county level where the enterprise is located, issued with a Pharmaceutical Trading License, and registered with the administrative department for industry and commerce on the strength of the Pharmaceutical Trading License. No drug business license, no drug business.
(2) Good Manufacturing Practices (GMP) system and GMP system.
Pharmaceutical production enterprises must organize production in accordance with the good manufacturing practice formulated by the drug supervision and administration department of the State Council. The pharmaceutical supervisory and administrative department shall, in accordance with the provisions, certify whether the pharmaceutical production enterprises meet the requirements of good manufacturing practice; Those who pass the certification will get the certification certificate.
Pharmaceutical trading enterprises must engage in business activities in accordance with the "Quality Management Standards for Pharmaceutical Trading" formulated by the drug supervision and administration department of the State Council. The pharmaceutical supervisory and administrative department shall, in accordance with the provisions, certify whether the pharmaceutical production enterprises meet the requirements of good manufacturing practice; Those who pass the certification will get the certification certificate.
(3) Drug registration system
According to the new Measures for the Administration of Drug Registration, drugs must be registered before they can be produced and sold. There are five types of drug registration applications: new drug application, generic drug application, imported drug application, supplementary application and re-registration application. The production of new drugs or drugs with national standards must be approved by the drug supervision and administration department of the State Council, and a drug approval number shall be issued. A pharmaceutical production enterprise can produce the drug only after obtaining the drug approval number.
The new Measures for the Administration of Drug Registration has greatly improved the scientificity and transparency of the registration and approval of new drugs, and clearly stipulated that "those who change dosage forms, routes of administration and add new indications will no longer be approved as new drugs", and it is clear that innovative drugs have the right to apply for approval quickly, and the gold content of new drugs will be greatly improved.
(4) National drug standard system
National drug standards refer to the technical requirements such as quality index, inspection method and production technology formulated by the state to ensure the quality of drugs, including People's Republic of China (PRC) Pharmacopoeia, Drug Registration Standards and other drug standards promulgated by SFDA. The State Council drug supervision and administration department organizes Pharmacopoeia Committee, which is responsible for the formulation and revision of national drug standards.
(5) Drug price system
Drugs listed in the national basic medical insurance drug list and drugs with monopolistic production and operation outside the national basic medical insurance drug list shall be subject to government pricing or government guidance; Other drugs are subject to market-adjusted prices. Pharmaceutical production enterprises, trading enterprises and medical institutions must implement government pricing and government-guided prices, and shall not raise prices in any form without authorization.
(6) classified management system of prescription drugs and over-the-counter drugs
China implements a classified management system for prescription drugs and over-the-counter drugs. By strengthening the supervision and management of prescription drugs and over-the-counter drugs, standardizing the production and operation of drugs, guiding the public to use drugs scientifically and rationally, reducing the occurrence of drug abuse and adverse drug reactions, and ensuring the safety of public drug use.
(7) Chinese medicine protection system
Traditional Chinese medicine industry is a traditional advantage industry in China, and it is also an important development direction in the future pharmaceutical production field. The state actively supports the development of ethnic medicine industry. On the basis of formulating a series of relevant policies to promote the healthy development of the pharmaceutical industry, the Regulations on the Protection of Traditional Chinese Medicine Varieties and the Regulations on Traditional Chinese Medicine in People's Republic of China (PRC) were promulgated and implemented to promote the sustainable and healthy development of scientific research and production of traditional Chinese medicine.
(8) biological products batch issuance system
According to the Measures for the Administration of Batch Issuance of Biological Products, batch issuance of biological products refers to the system of compulsory inspection and audit of vaccine products, blood products, in vitro biological diagnostic reagents used for blood source screening and other biological products specified by the US Food and Drug Administration. Those who fail to pass the inspection or the inspection shall not be listed or imported.
(9) Blood products management system
The business of blood products must comply with the Regulations on the Administration of Blood Products, the Quality Management Standard for Plasma Collection Stations, the Basic Standards for Plasma Collection Stations and the Guiding Principles for the Establishment Planning of Blood Collection and Supply Institutions.
(10) narcotic drugs and psychotropic drugs management system
The management of narcotic drugs and psychotropic drugs shall abide by the Regulations on the Administration of Narcotic Drugs and Psychotropic Drugs, the Measures for the Administration of Narcotic Drugs and Psychotropic Drugs (for Trial Implementation) and other relevant laws and regulations.
(1 1) Medical Device Management System
China implements a production license and product registration system for the production of medical devices. The main laws and regulations of the medical device industry promulgated in China include Regulations on the Supervision and Administration of Medical Devices (Order No.276 of the State Council), Measures for the Supervision and Administration of Medical Device Production (Order No.1 12 of the State Medical Device Administration) and Measures for the Administration of Medical Device Registration (Order No.1 16 of the State Medical Device Administration). In addition, when medical device products enter the international market, they should not only apply the relevant laws and regulations on medical device management in the importing country, but also pass the certification of relevant medical device supervision and management institutions, such as ISO: 13485 certification, US FDA registration, EU ce certification, Japan SG certification, etc.
(12) Environmental protection standards of pharmaceutical industry are becoming stricter.
On August 1 day, 2008, the Discharge Standard of Water Pollutants for Pharmaceutical Industry (hereinafter referred to as the Standard) formulated by the State Environmental Protection Administration was formally implemented.
The standard requires pharmaceutical enterprises to treat sewage to a certain extent before it can be discharged into natural water bodies and sewage treatment plants, which forces pharmaceutical enterprises to purchase sewage treatment equipment and build sedimentation tanks, aeration tanks and other related projects. At the same time, they should pay more attention to reducing and controlling the pollution sources in the whole production process. Therefore, pharmaceutical companies will spend a lot of money on this as an investment in pre-facilities In addition, the standard stipulates that the existing enterprises shall implement the water pollutant discharge limit of newly-built enterprises from July 20 10/day. In other words, with the promotion of environmental protection, the cost of pollutants reaching the standard in the later period is much higher than that in the earlier period, which means that the cost of new sewage treatment for pharmaceutical companies will rise linearly in the later period. Therefore, the implementation of standards will cost pharmaceutical companies a lot, and the pollution control cost of pharmaceutical companies will gradually become an important part of product cost competition in the future.