National drug standards are mainly composed of China Pharmacopoeia, standards issued by the Ministry (bureau) and registration standards. Its main contents include technical requirements such as drug quality index, inspection method and production technology. In the management of drug production, circulation and use, the government must take drug standards as technical standards to ensure the seriousness, authority, impartiality and reliability of each link.
Directory set
As a drug information carrier approved by the Food and Drug Administration, the catalogue is the result of comprehensively promoting the reform of drug evaluation and approval.
It marks the further improvement of China's generic drug management system: on the one hand, the catalogue contains innovative drugs and original drugs, and stipulates reference preparations (imitation objects), which provides standards for generic drug research and development.
On the other hand, the catalogue contains drugs that have passed the consistency evaluation of quality and efficacy, which provides a basis for clinical replacement of generic drugs and original drugs. At the same time, the catalogue will serve as a carrier for carrying the patent linking system and provide institutional guarantee for the balanced development of innovative drugs and generic drugs.