(1) drug production and management licensing system
According to the Drug Administration Law, the opening of a drug production enterprise, subject to the approval of the drug supervision and management department of the people's government of the province, autonomous region and municipality directly under the central government where the enterprise is located and issued a "drug production license", with a "drug production license" to the administrative department of industry and commerce for registration. No "drug production license", shall not produce drugs.
According to the "Drug Administration Law", the opening of pharmaceutical wholesale enterprises, shall be approved by the enterprise location of the provincial, autonomous regions and municipalities directly under the Central People's Government drug supervision and management department and issued the "drug license"; the opening of the drug retail business, shall be approved by the enterprise location of the county-level or above, the local drug supervision and management department and issued the "drug license", with the "drug license" to the administrative department for industry and commerce for registration. With the Drug Operation License, the enterprise shall apply for registration with the administration for industry and commerce. Without the Drug Business License, shall not operate drugs.
(2) Good Manufacturing Practice (GMP) system and Good Supply Practice (GSP) system
Pharmaceutical manufacturers must organize their production in accordance with the Good Manufacturing Practice (GMP) formulated by the State Council's drug supervision and administration department. Drug supervision and management department in accordance with the provisions of the drug production enterprises to meet the requirements of the "Good Manufacturing Practice" for certification; qualified certification, the issuance of certification.
Pharmaceutical enterprises must be in accordance with the State Council drug supervision and management department formulated the "Drug Business Quality Management Standards" to engage in business activities. Drug supervision and management department in accordance with the provisions of the drug production enterprises to meet the requirements of the "Good Manufacturing Practice" for certification; qualified certification, issued by the certificate of authentication.
(3) Drug Registration System
According to the new Measures for the Administration of Drug Registration, drugs can only be manufactured and sold after registration. Applications for drug registration include five types: applications for new drugs, applications for generic drugs, applications for imported drugs and their supplementary applications and applications for re-registration. The production of a new drug or a drug for which a national standard has been set is subject to the approval of the Drug Administration under the State Council and the issuance of a drug approval number. Drug manufacturers can only produce the drug after obtaining the drug approval number.
The new Administrative Measures for Drug Registration greatly improves the science and transparency of the registration and approval of new drugs, specifying that "changes in dosage forms, routes of administration, and the addition of new indications will no longer be approved as new drugs", and clarifying that innovative medicines have the right to fast-track their applications and approvals, and that the gold content of new medicines will be greatly improved.
(4) National Drug Standard System
National drug standards refer to the quality indicators, test methods, and technical requirements of the production process formulated by the state to ensure the quality of medicines, including the Pharmacopoeia of the People's Republic of China issued by the SFDA, the standards for registration of medicines, and other drug standards. The Drug Administration under the State Council organizes the Pharmacopoeia Committee, which is responsible for the formulation and revision of national drug standards.
(5) Drug Pricing System
Drugs included in the National Basic Medical Insurance Drug List, as well as drugs with monopoly production and operation outside the National Basic Medical Insurance Drug List, are subject to government pricing or government-guided pricing; for other drugs, market-adjusted prices are in effect. The manufacturers, operators and medical institutions of medicines must implement the government pricing or government-guided prices, and may not raise prices in any form without authorization.
(6) Classification and management system of prescription and non-prescription drugs
China has implemented a classification and management system of prescription and non-prescription drugs. By strengthening the supervision and management of prescription drugs and non-prescription drugs, it regulates the behavior of drug production and operation, guides the public to use drugs in a scientific and reasonable manner, reduces drug abuse and the occurrence of adverse drug reactions, and protects the public's safety of drug use.
(7) Protection of Traditional Chinese Medicines
The traditional Chinese medicine industry is a traditional advantageous industry in China, and is an important direction for the future development of China's pharmaceutical production. The state actively supports the development of the national Chinese medicine industry, and on the basis of a series of relevant policies to promote the healthy development of the pharmaceutical industry, it has also promulgated and implemented the Regulations on the Protection of Varieties of Chinese Medicines and the Regulations on Traditional Chinese Medicine of the People's Republic of China in order to promote the continuous and healthy development of the development and production of Chinese medicines in China.
(8) Biological products batch issuance system
According to the "Administrative Measures for the Batch Issuance of Biological Products", the batch issuance of biological products refers to the state of vaccine products, blood products, in vitro bio-diagnostic reagents used for blood screening, as well as the State Food and Drug Administration stipulated in the other biological products, the batch of products for each batch of mandatory inspection and audit system when they are listed in the factory or imported. Failure to pass the test or audit is not approved, shall not be listed or imported.
(9) Blood Products Management System
The blood products business is subject to the Regulations on the Administration of Blood Products, the Code of Practice for the Quality Management of Single Collection Plasma Stations, the Basic Standards for Single Collection Plasma Stations, and the Guidelines for Planning the Setup of Blood Collection and Supply Institutions, and other relevant regulations.
(10) Management System of Narcotic Drugs and Psychotropic Substances
Narcotic drugs and psychotropic substances business is subject to the Regulations on the Administration of Narcotic Drugs and Psychotropic Substances, Measures for the Administration of Narcotic Drugs and Psychotropic Substances Business (for Trial Implementation), and other relevant regulations.
(11) Medical Device Management System
China adopts a production license and product registration system for the production of medical devices. The main laws and regulations promulgated by China regarding the medical device industry are Regulations for the Supervision and Administration of Medical Devices (State Council Decree No. 276), Measures for the Supervision and Administration of the Manufacture of Medical Devices (State Pharmaceutical Administration Decree No. 12), and Measures for the Administration of the Registration of Medical Devices (State Pharmaceutical Administration Decree No. 16), etc. In addition, medical device products enter into the international market. In addition, medical device products into the international market, to apply the importing country related medical device management laws and regulations, but also need to pass the relevant medical device regulatory bodies of certification, such as ISO: 13485 certification, the U.S. FDA registration, the European Union CE certification and Japan's SG certification and so on.
(12) Pharmaceutical industry environmental standards are becoming increasingly stringent
August 1, 2008, by the State Environmental Protection Administration of the pharmaceutical industry water pollutant discharge standards (hereinafter referred to as "standards") began to be formally implemented.
The Standard requires pharmaceutical companies to treat wastewater to a certain level before discharging it to natural water bodies and wastewater treatment plants, which forces pharmaceutical companies to purchase wastewater treatment equipment, and construction of sedimentation tanks, aeration tanks and other related projects, while at the same time, but also to increase the emphasis on the production process of pollution source reduction and control, so the pharmaceutical companies will be spending a lot of money for this as a pre-facility investment. In addition, the "standards" in the provisions of the existing enterprises since July 1, 2010, the implementation of new enterprises discharge limits of water pollutants, that is to say, with the advancement of environmental protection and governance, the late realization of the pollutants to meet the requirements of the cost is much higher than the pre-compliance cost of pollutants, which means that the pharmaceutical companies later added sewage treatment costs will rise linearly. Therefore, the implementation of the "standard" for pharmaceutical companies is to pay a high cost of expenditure, and in the future the cost of pollution control of pharmaceutical companies will gradually become an important part of the product cost competition.