摘要
Objective To study whether the reference preparations of 289 list are determined and to analyze why some reference preparations are not put on file,and suggestions are raised for follow-up work.Methods Selection principles,situations of filing and releasing of reference preparations were clarified,289 listed items were classified and each reference preparation was discussed respectively.Results and Conclusion Reference preparations of 289 list were determined basically.Up to February 2018,42 drugs had not been put on file,18 of which had no other dosage form of same generic names filing at the same time.Besides,4 of these 18 varieties had been removed from the National Essential Medicine List.The clinical alternatives of the remaining 14 varieties should be further evaluated so as to avoid the cases that the low-cost drugs will be removed from the National Essential Medicine List due to failure of consistency evaluation.Meanwhile,those irrational dosage forms that cannot pass the consistency evaluation should be removed from the National Essential Medicine List gradually.
作者简介
Corresponding author:Tian Lijuan,associate professor.Major research area:pharmaceutical regulations and drug policies.Tel:18341400139,E-mail:tianlijuan_8@126.com.
