What does the national patent medicine mean?

National patented drugs refer to new chemical monomer drugs that apply for patents. Its development process includes discovery stage, pre-clinical development, pre-clinical application of new drugs, the first stage of new drug clinical trials, new drug clinical trials, new drug clinical trials and new drug applications. These drugs can only be produced by companies that own these patented drugs or can be transferred to others for production.

Legal basis:

People's Republic of China (PRC) Drug Administration Law

Article 1 This Law is formulated with a view to strengthening drug administration, ensuring drug quality, safeguarding the safety and legitimate rights and interests of the public in drug use, and protecting and promoting public health.

Article 2 This Law shall apply to the research, production, trading, use, supervision and administration of drugs within the territory of People's Republic of China (PRC). Drugs mentioned in this Law refer to substances used for preventing, treating and diagnosing human diseases, purposefully regulating human physiological functions, and specifying indications or functional indications, usage and dosage, including traditional Chinese medicines, chemicals and biological products.

Article 3 Drug management should focus on people's health, adhere to the principles of risk management, whole-process control and social governance, establish a scientific and strict supervision and management system, comprehensively improve drug quality, and ensure drug safety, effectiveness and accessibility.

Article 6 The State implements the drug marketing license holder system for drug administration. The holder of the drug marketing license is responsible for the safety, effectiveness and quality controllability of the whole process of drug research and development, production, management and use according to law.