Since 2018, China has carried out 8 batches of national organized drug procurement, involving 333 types of drugs. Starting from June 2021, the National Medical Security Administration has entrusted Xuanwu Hospital of Capital Medical University to lead the second phase of real-world clinical efficacy and safety research on 23 representative varieties collected by the second and third batches of national organizations. On October 17th, the National Medical Security Administration held a press conference to introduce relevant research results and respond to public concerns about the efficacy and safety of generic drugs. The clinical efficacy and safety of selected generic drugs in centralized procurement are comparable to those of the original research drugs. Zhang Lan, the leader of the research group and director of the Pharmacy Department of Xuanwu Hospital of Capital Medical University, introduced that this study evaluated 23 drugs by directly comparing the selected drugs in centralized procurement with the original research drugs, collecting clinical case data from a large sample, selecting targeted observation indicators, and using statistical methods to balance some differences between the groups during the analysis process, It involves six major fields, including anti infection, anti-tumor, metabolism and endocrine, neuropsychiatric, cardiovascular and cerebrovascular, and digestive system acid suppression. Zhang Lan introduced that based on the results of this study, it can be concluded that the clinical efficacy and safety of the selected generic drugs in centralized procurement are comparable to those of the original research drugs. On October 17th, a press conference was held on the "Real World Research Results on the Clinical Efficacy and Safety of Selected Generic Drugs in the Second and Third Batch of National Organizations. Zhang Lan, a reporter of Xinhua News Agency Mu Tiecheng, also said that the effectiveness of any drug is probabilistic. For example, among people with diabetes, some patients will have poor efficacy when using certain hypoglycemic drugs, which can be found in both original research drugs and generic drugs. Only through a controlled study of a certain population can scientific conclusions be drawn, "said Bian Xiaolan, a member of the research group and director of the Pharmacy Department of Ruijin Hospital affiliated with Shanghai Jiao Tong University. Real world research reflects the actual diagnosis and treatment process and changes in patient health conditions under real conditions, and objectively evaluates the safety and effectiveness of medication in real environments. The stability of consistency evaluation under multi-pronged escort "An important content of consistency evaluation for generic drugs in China is pharmaceutical equivalence evaluation. Pharmaceutical equivalence requires that generic drugs must have the same active ingredients, content, administration route, dosage form as the original drug, and comply with drug quality standards." Zhang Lan introduced that after consistency evaluation, regulatory authorities will still evaluate the production, circulation, and Use for full chain quality supervision. Zhang Lan introduced that drug regulation is not only the regulation of results, but also the regulation of processes. As required by regulatory authorities, ensure that the production process is consistent with the approved process, ensure that the quality of each batch of drugs sold is consistent with the declared sample, ensure continuous research on marketed drugs, and report adverse reactions in a timely manner. In addition, relevant departments have considered in advance in the system design and set up a complete set of safeguard measures. The drug regulatory department requires local drugs to complete a comprehensive sampling inspection of the production process of national organized drug centralized procurement selection varieties, national essential drug formulation varieties, and varieties evaluated for quality and efficacy consistency through generic drugs produced by enterprises within their jurisdiction every year. Zhang Lan said that it can be seen from this that China's drug regulatory department
Edit：Hou Wenzhe Responsible editor：WeiZe
Source：XinhuaNet
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