CFDA publishes 288 references and only 4 references in 289 catalogue

The consistency evaluation of generic drugs has entered the second half of the year CFDA has accelerated the list of reference preparations 288 pieces of information have been published this time, especially the tenth batch, which is more than 284 pieces It's very difficult to choose whether the 289 catalog products in the 10th batch are for some consideration or for reference in the 289 catalog In the 284 catalog of reference preparations published in the 10th batch, there are no reference preparations in the 289 catalog products CFDA is becoming more and more considerate The remarks are detailed Article 898 overall analysis of reference preparations 1 Overall situation, as shown in the figure below, the first six batches are basically stable, and the eighth and tenth batches are significantly increased It can be seen that CFDA is also accelerating the publication of reference preparations There are only four articles in the ninth batch, but they are all products in the 289 catalogue 2 The data shows that the number of non 289 directories is significantly higher than that of 289 directories, accounting for 74% Up to now, there are 235 records in 289 directories, and 663 records in non 289 directories Some friends will be surprised that their statistics are not like this Here is a brief introduction Although 68 record names are in 289, their specifications are not consistent with those published in 289 directory, so they are also listed in non 289 directory 3 Up to now, 162 varieties with 289 catalogues have published reference preparations, accounting for 56% 4 Finally, let's look at the source of the reference preparation As shown in the figure below, the largest source is the original research import, followed by the American orange book It is also in line with the principle of priority in the selection of reference preparations for original research and import The above is a brief analysis of the author For details, please visit the catalogue of generic reference preparations.