In accordance with the Announcement on the Issuance of Procedures For the Selection and Determination of Chemical Generic Reference Formulations (No. 25, 2019) issued by the State Drug Administration on March 28, 2019, in order to standardize the review and consistency evaluation of generic drugs, optimize the working procedures, strengthen service guidance, and ensure fairness, fairness and openness, the drug review center organized the selection of the 22nd batch of reference formulations Publicity will be held from June 3 to 17, 2019.![发布第22批仿制药参比制剂目录 发布第22批仿制药参比制剂目录]()
In our study, the number of published reference formulations is 22 batches with the largest number, involving 495 standards, of which 225 injection standards account for about 45.45%.
In addition to conventional tablets, capsules and injections, the reference formulations released this time include some special dosage forms, including powders, patches, inhalants, powders, ointments, etc.
Up to now, a total of 22 batches of reference formulations have been released, with a total of 1998 product specifications.