Analysis of the current situation of the approval of generic drugs in China

According to the drug intelligence registration and acceptance database, we first screened out the drugs with the application type of imitation or the existing national standards, and further excluded the pharmaceutical excipients and in vitro diagnostic reagents Compared with chemical drugs, the number of application of traditional Chinese medicine generic drugs can be ignored in the statistics, because the following statistics on generic drugs only included in chemical generic drugs, namely chemical drugs 6 categories Figure 1 change trend chart of CDE acceptance quantity of chemical drugs and generic drugs from 2011 to 2014 Calculated from the trend chart of application quantity, the growth rate of acceptance quantity of chemical drugs from 2011 to 2014 is 0.5%, 6.5%, 20.8% respectively; the growth rate of generic drugs is 4.5%, 18.7%, 4.0% respectively If this data can not completely present some problems, let's look at the figure below Figure 2 ratio of acceptance quantity of chemical generic drugs to total acceptance quantity of chemical drugs 1 In terms of acceptance quantity, 2013 is a turning point, and the growth rate of chemical generic drugs has declined since 2013; 2 The proportion of chemical generic drugs in the whole acceptance quantity has also declined since 2013 In 2014, the number of chemical acceptance increased rapidly Compared with 2013, the growth rate was 20.8% Generic drugs only maintained a relatively low growth trend In a comprehensive view, under the current policy environment, enterprises will be more inclined to apply for chemical 1-5 new drugs, especially 3.1 new drugs Let's take a look at the approval of CDE generic drugs Figure 3: the number of generic drugs approved by CDE in 2012-2014 Seeing this, I think many people began to beat their hearts and beat their feet, drawing a circle and scolding CDE countless times From the perspective of statistical data, the approval rate of CDE for generic drugs has decreased year by year In 2013 and 2014, the approval rate of CDE for generic drugs has basically maintained 400 / year As of January 27, 2015, the chemical anda serial number has reached 8253, and the number of new acceptances each year is about 2000 We can only say in silence: CDE is terrible, and copying should be cautious It's not just the nonsense of the editor, but the data: from CDE to the issuance of approval documents, we have been waiting for 8 years! Why do you have to wait for Zhao for seven years? Look at these enterprises, maybe you can understand what is true love Another more painful question is to understand that the declaration may not be approved According to the drug intelligence registration and acceptance database, the number of chemical drugs approved for production is as follows: figure IV the number of generic drugs approved for production in 2012-2013 figure III and figure IV are compared, and the approval rate of chemical drugs can be calculated, 50.6%, 46.2% and 53.8% respectively in 2012-2014 Seeing this result, a large number of people began to hide and cry quietly They had to wait for many years, but the elimination rate was 50% Drug registration is always a few happy several worries, a deep sea like registration, can only say: take care!