Yesterday, the National Medical Insurance Administration held a press conference to introduce the results of real-world research on the clinical efficacy and safety of selected generic drugs in the second and third batches of national organized drug centralized procurement. At the meeting, Zhang Lan, the leader of the research group and director of the Pharmacy Department of Xuanwu Hospital of Capital Medical University, stated that the efficacy and safety of the selected generic drugs after price reduction in centralized procurement are equivalent to those of the original research drugs. It is understood that since 2018, China has carried out 8 batches of centralized procurement of nationally organized drugs, involving 333 varieties. In order to truly and comprehensively understand the safety and effectiveness of selected generic drugs in centralized procurement, since 2021, the National Medical Insurance Administration has organized medical institutions such as Xuanwu Hospital to conduct real-world research on the clinical efficacy and safety of selected generic drugs in the second and third batches of national bulk procurement. Over the past two years, significant research results have been achieved recently. Zhang Lan pointed out that this study conducted a direct control of 23 representative varieties and original research drugs collected by the second and third batches of national organizations in six major fields, including anti infection, anti-tumor, metabolism and endocrine, mental, cardiovascular, and digestive systems, collected clinical case data from a large sample, selected targeted observation indicators, and used statistical methods to balance some differences between groups during the analysis process. The selected generic drugs from 38 manufacturers were evaluated, Form research conclusions. Overall, it can be concluded that the clinical efficacy and safety of the selected generic drugs in the centralized procurement are comparable to those of the original research drugs, "said Zhang Lan. The National Medical Insurance Administration stated that in the next step, it will continue to conduct real-world evaluations of selected generic drugs in subsequent batches of centralized procurement, providing evidence-based support for clinical medication. Regarding some public opinions that the efficacy of selecting generic drugs in centralized procurement is not as good as that of the original research drugs, Zhang Lan stated that the effectiveness of any drug (whether it is the original research drug or a generic drug) is probabilistic, In our study, a large sample analysis showed that the blood glucose compliance rate of the original and generic formulations of metformin hydrochloride tablets was around 80%, with no statistically significant difference. This also indicates that about 20% of patients, whether it is the original or generic formulation, have poor efficacy in individual treatment, and they need to use other treatment methods or drugs. Zhang Lan stated that in a large group, some patients may experience poor efficacy when using a certain type of hypoglycemic drug, which is common in both original and generic drugs. "It is clearly unscientific and unfair to select cases with poor efficacy of generic drugs and provide targeted descriptions to draw the conclusion that generic drugs are not effective. In response to some concerns that the "consistency evaluation" of generic drugs may become a "one-time evaluation", Zhang Lan emphasized that an important aspect of consistency evaluation of 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. Moreover, consistency evaluation is not a "talisman" or "passport" for drug quality. After consistency evaluation, regulatory authorities will still conduct full chain quality supervision over the production, circulation, and use of drugs. For example, in the production process, there is a complete quality control and supervision system from raw material selection to the production process. Only the replacement of pharmaceutical raw material suppliers requires
Edit：GuoGuo Responsible editor：FangZhiYou
Source：people.cn
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