ABSTRACT
OBJECTIV E To in vestigate the situation ，achievements and proble ms of consistency evaluation policy of generic medicines in China. METHODS The descriptive analysis was performed after collecting and sorting out the information of generic medicine passing consistency evaluation （GMPCE） published on the official website of the National Medical Products Administration. The basic information ，the distribution and changes of GMPCE were analyzed statistically in National Essential Medicine List （hereinafter refer to as “essential medicine list ”），Medicine List for National Basic Medical Insurance ，Industrial Injury Insurance and Maternity Insurance （hereinafter refer to as “medical insurance list ”）and the result of the successful selection of centralized medicine procurement organized by the state （hereinafter refer to as “centralized procurement list ”）. RESULTS From 2017 to 2021，415 chemical generic drugs had passed consistency evaluation in China ，including 309 varieties，1 822 specifications， 6 dosage forms ，and 17 pharmacological mechanisms ，basically belonging to 30 provinces，and 492 drug manufacturers （except 12 products had not been found the manufacturers ）；the proportion of GMPCE in essential medicine list increased from 0.96％ in 2012 edition to 25.40％ in 2018 edition；that of GMPCE in medical insurance list increased f rom 2.13％ in 2017 edition to 11.68％ in 2021 edition；in the first 5 batches of centralized procurement list，GMPCE accounted for 81.65％，and the maximum price drop after entering the list was 97.52％. CONCLUSIONS The policy linkage has been achieved with the continual increase of the number of GMPCE and their total amount in three lists in China. The accessibility and affordability of related medicines have been improved with the apparent decrease of the price of those medicines. H owever，total number of GMPCE is a little small，with the higher repetition rate of variety and the low proportion in the three lists ；the guarantee measures of those medicine supply need to be strengthened.
ABSTRACT
OBJECTIVE：To provi de reference for classification ，selection and management of antibacterial drugs in medical institutions. METHODS ：The adjustment of antibacterial drug list in 2019 edition of National Basic Medical Insurance ，Work Injury Insurance and Maternity Insurance （called“New List ”for short ）was introduced. The politic reference of selection and adjustment of antibacterial drugs and the principle of classification selection in medical institutions were sort out. The challenges which may bring to pharmaceutical administration and clinical use in medical institutions were investigated. RESULTS & CONCLUSIONS： Three new varieties of the antibacterial drugs in the New List have been added ，including Doxycycline injection，Faropenem granules and Metronidazole oral regular-release preparations. Nine product specifications were excluded ，such as Tetracycline oral regular-release preparations ，Dirithromycin oral regular-release preparations ，etc. The limitation of indications and/or indications of 19 regulations was modified ，and some antibacterial requirements were limited to patients with clear evidence of drug sensitivity test or severe infection. When classifying and selecting antibacterial drugs ，medical institutions should take the existing policy documents as the basis ，strictly implement the relevant provisions of antibacterial drug management ，give priority to meeting various national prescription sets and drug list varieties ，select drugs with sufficient evidence-based treatment basis ，drug quality and safety ，and take into account the convenience and economy of drug use ，supply guarantee service capacity of drug production and circulation enterprises and local situation of pathogenic bacteria resistance. The adjustment of New List also brings challenges to use and management of antibacterial drugs in medical institutions. For example ，New List emphasizes“limited drug sensitivity evidence ”for many antibacterial specifications. But if the clinicians choose drugs mechanically according to the drug sensitivity results and ignores the experience treatment in anti-infection treatment ，another type of “abuse”may be abused ；in addition，the indications of myxomycetin B and colistin （sulfate myxomycetin ）are completely different ，which also deserves further study.
