The number of reference filings continues to be low, and one third of the filing varieties have been announced for reference

On August 8, 2017, the generic drug quality research center of the Chinese Academy of inspection released the filing information of the 10th batch of reference preparations Up to now, there are 5655 records, including 945 varieties and 882 enterprises; among them, there are 3157 records in the 289 catalog, including 242 varieties and 652 enterprises 1 Overall analysis of filing type: Generally speaking, the filing of reference preparations has been carried out for 15 months, and the number has remained low since 2017 In addition, CFDA published 8 batches of reference catalogue, and the focus of enterprises began to shift The types of filing include filing, declaration and recommendation Most domestic enterprises choose the way of filing, while foreign enterprises pay attention to the layout of the original research drug application 2 Analysis of 289 catalog and non 289 catalog filing type the author makes a brief comparative analysis of 289 catalog and non 289 catalog, and makes statistics from two dimensions of record number and variety number In general, enterprises focus not only on the 289 directory, but also on the non 289 directory In terms of application types, it can be seen that the variety of non 289 catalogue is significantly higher than that of 289 catalogue According to the statistics (number of records) of 289 catalog and non 289 catalog varieties, 3 One third of the varieties have published reference data As of July 20, the quality research center for generic drugs of the Chinese Academy of inspection published 5655 pieces of data, including 945 varieties CFDA published a total of 610 reference preparations and 368 varieties Through statistics, it is found that there are 3509 records (62.1% of the total) in the record data of reference preparations, and 318 varieties are listed in the catalogue of reference preparations published by CFDA Due to the disorder of specification data, the statistics are all related to specifications What I just said is a bit awkward In short, about one-third of the reference preparations filed by enterprises have been given the final answer by CFDA Of course, it does not mean that there is a certain error if it is inconsistent with CFDA's announcement It has been verified before that a variety of reference preparations can be manufactured by multiple manufacturers, and the products of the same manufacturer can also come from different countries If the enterprise feels that its choice is well documented, it can also raise an objection to CFDA, so as not to let the previous work be done in vain For example, captopril tablets are shown in the figure below CFDA has published 12.5mg and 25mg reference preparations First, 12.5mg captopril tablets, CFDA announced Daiichi Sankyo espha Co., Ltd It can be seen from the query of reference filing database that there are 9 filing information of 7 enterprises in total, of which 6 selected Daiichi Sankyo espha Co., Ltd., 3 selected mylan pharmaceuticals Inc., and the accuracy is still 2 / 3 Among them, Changzhou Pharmaceutical Factory Co., Ltd has selected two manufacturers for reference, which is double insurance I wonder if both of them are used in his actual research? There are two companies that are not so lucky Secondly, 25 mg captopril tablets, CFDA announced Daiichi Sankyo espha Co., Ltd and E.R Squibb & Sons Limited (origin: Italy) There are 46 records in the reference preparation record database, which come from 35 enterprises Among them, 13 records chose Daiichi Sankyo espha Co., Ltd, 5 records chose mylan company, and the remaining 27 records chose Squibb (only 16 records clearly pointed out that the origin was Italy) In a strict sense, the accuracy was 63% Captopril tablets are relatively simple in the selection of reference preparations, and the accuracy is a little more than 60% For some complex varieties, the accuracy must be lower I still hope that all enterprises pay more attention to their own varieties and know them well The above is a brief analysis of the author's record I hope that readers can put forward their own views and discuss more Data source: generic reference drug catalog database