Ergodine management system

Legal Analysis: All manufacturers of ergotoxine derivatives (including dihydroergotoxine mesylate, nicergoline, dihydroergotoxine mesylate, ergotoxine caffeine, ergotoxine caffeine, α-dihydroergotoxine mesylate) should submit supplementary applications for revision of instructions in accordance with the Measures for the Administration of Drug Registration and other relevant regulations (see Annex).

Legal basis: Drug Administration Law of People's Republic of China (PRC).

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 the quality of drugs, and ensure the safety, effectiveness and accessibility of drugs.

Article 4 The state develops modern medicine and traditional medicine and gives full play to their roles in prevention, medical treatment and health care. The state protects wild medicinal resources and varieties of traditional Chinese medicine, and encourages the cultivation of genuine medicinal materials.

Article 93 The state implements the system of essential drugs, selects an appropriate number of essential drugs, strengthens the organization of production and storage, improves the supply capacity of essential drugs, and meets the demand for essential drugs for disease prevention and control.