Analysis of evaluated generic drugs from the perspective of the National Essential Medicine List
Objective To explore the situation of generic drugs that have undergone consistency evaluation within Chi-na's Essential Medicines and the prevalence of excessive replication among these generics.Methods Data on generic drugs that passed the consistency evaluation from August 1 2017 to September 1 2023 was collected from the National Medical Prod-ucts Administration.This data was analyzed to assess the excessive replication of these generics and examine their distribution and changes within the 2018 version of the National Essential Medicines List.Results A total of 7431 generic drug products from various manufacturers were collected,comprising 2818 specifications and 1170 varieties across 26 pharmacological cate-gories and 41 dosage forms.Of the 438 essential medicines,135(30.8%)had all specifications represented by evaluated ge-nerics,104(23.7%)had some,and 199(45.4%)had none.Of these,1128 specifications were analyzed,614(54.4%)of which had no evaluated generics,while 514(45.6%)did.Furthermore,326(63.4%)specifications had 1 to 3 redundant evaluated products,79(15.4%)had 4 to 6,and 109(21.2%)had seven or more.Conclusion The production of generics within China's Essential Medicines List shows significant unevenness,particularly in the excessive replication of evaluated ge-nerics in some essential medicines.
National Essential Drugs Listgeneric drugsconsistency evaluationduplicate
NETL
NSTL
万方数据
