Objective: To study the establishment of generic reference formulations in China's National Essential Drug List and provide a scientific basis for the selection of generic reference formulations. Methods: The generic reference formulations released by National Medical Products Administration were matched with the drugs in the National Essential Drug List, and the matching situation and post-matching characteristics were analyzed. Descriptive analysis with chi-square test was used for statistical analysis. Results: Total 417 kinds of chemical drugs and biological products were included in the 2018 edition of the National Essential Drug List, of which 112 kinds (27%) did not have any corresponding dosage forms and specifications of reference formulations. Among the 4509 reference formulations released, 59% of them are not essential drugs. The number of dosage forms and specifications of domestic unmarketed reference formulations was significantly greater than the number of domestic marketed reference formulations (Z=-6.86, p<0.01). Among the 682 originally imported reference formulations marketed in China, the proportion of essential drugs was 13%; among the 3646 originally imported reference formulations which have not marketed in China, the proportion of essential drugs was 20%. The difference between them was statistically significant (χ2 =97.7, p<0.01). Conclusion: The number of reference formulations is increasing in China, while there is still a large proportion of missing reference formulations for essential drugs. Although dosage forms and specifications of reference formulations are complex and diverse, most of them are not included in the National Essential Drug List. These characteristics lead to greater challenges on the selection and utilization of reference formulations of essential medicines.
Zhao Fei, Zhao Zinan, Xue Wei, Qi Wenyuan, Yao Huiqing, Wang Juan, Xu Xiaoyu, Liu Xiaohui, Jin Pengfei, Ji Liwei, Zhang Yatong, Li Kexin, Hu Xin
. On the Establishment of Generic Reference Formulations in China's National Essential Drug List[J]. Chinese Pharmaceutical Affairs, 2021
, 35(9)
: 972
-978
.
DOI: 10.16153/j.1002-7777.2021.09.002
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