National drug standards include: pharmacopoeia standards; Ministry of Health Chinese Medicine Prescription Preparation Standards; Ministry of Health Chemical, Biochemical, Antibiotic Drug Standards; Ministry of Health Drug Standards; Ministry of Health Drug Standards Tibetan Medicine Standards; Criteria for new drugs to become regulars; National Drug Standards, Chemical Drug Standards; National standards for proprietary Chinese medicines; National registration standards; Standards for Imported Drugs.
1. Composition of national drug standards
The State Food and Drug Administration issued the Measures for the Administration of Drug Standards to further standardize and strengthen the management of drug standards, ensure the safety, effectiveness and controllable quality of drugs, and promote the high-quality development of drugs. The measures clarify that China's drug standard system includes national drug standards, drug registration standards and provincial traditional Chinese medicine standards, and clarify the formulation and revision procedures, requirements and relationships of the three types of standards. The measures will come into force on January 1, 2024.
The measures point out that the national drug standards include the Chinese Pharmacopoeia and the drug standards issued by the bureau (ministry). Among them, the drug standards issued by the bureau (ministry) refer to the drug standards promulgated by the former Ministry of Health, the former Food and Drug Administration and the State Food and Drug Administration. The measures systematically sort out the responsibilities of drug standard management institutions, and clarify the responsibilities of national drug standard management institutions such as the State Food and Drug Administration, the State Pharmacopoeia Commission, drug inspection institutions and drug evaluation institutions, as well as provincial drug standard management institutions.
2. The significance of national drug standards
National drug standards are of great significance in ensuring the safety, effectiveness, stability and controllability of drugs
1.Ensure drug safety: The national drug standards strictly stipulate the chemical composition and biological activity of drugs to ensure that drugs will not cause harm to the human body during use.
2.Guarantee the effectiveness of drugs: The national drug standards stipulate the content and dosage form of drugs to ensure that the drugs can achieve the expected results.
3.Ensure the stability of drugs: The national drug standards stipulate the storage and transportation of drugs to ensure the stability of drugs in the process of use.
4.Ensure the controllability of drugs: The national drug standards stipulate the production process and testing methods of drugs to ensure that the quality of drugs is controllable, so as to reduce the risks in the production process of drugs.
National drug standards include: pharmacopoeia standards; Ministry of Health Chinese Medicine Prescription Preparation Standards; Ministry of Health Chemical, Biochemical, Antibiotic Drug Standards; Ministry of Health Drug Standards; Ministry of Health Drug Standards Tibetan Medicine Standards; Criteria for new drugs to become regulars; National Drug Standards, Chemical Drug Standards; National standards for proprietary Chinese medicines; National registration standards; Standards for Imported Drugs. National drug standards are of great significance in ensuring the safety, effectiveness, stability and controllability of drugsThrough the understanding of national drug standards, people can use drugs with more confidence, and at the same time, it also helps to improve the level of drug production and supervision.