Comparison of application and review of new drugs in China in 2015

Source: Xianda data Jinglu 2016-01-04 China's annual cumulative declaration volume refers to the domestic cumulative declaration volume in the latest year, excluding supplementary application and review data China's annual cumulative review volume refers to the domestic cumulative review data of the latest year excluding supplementary application and review We can see the trend of declaration and review in China through the annual cumulative declaration and review As of January 1, 2015, Xianda data v3.2 found that China's declaration volume in 2013 was 3944, and the annual cumulative declaration volume increased to more than 4000 since January 2014, and the overall trend remained upward until April 2015, when the annual cumulative declaration volume was more than 5000 In July 2015, the annual cumulative declaration volume reached the highest peak of 5283, and then the annual cumulative declaration volume began to decline In 2015, the number of applications was 4890, up 3.5% from 4724 in 2014 In 2013, there were 2334 audit settlements in China Until April 2015, the annual cumulative audit settlements remained very stable at the level of less than 3000 In May 2015, there were 1367 audits in the current month, which promoted the annual cumulative audit volume of more than 3000 in May 2015 to 3758 The annual cumulative audit volume has been growing In August 2015, the annual cumulative audit volume exceeded 4000 In November 2015, the annual cumulative audit volume exceeded the annual cumulative declaration volume for the first time and the annual cumulative audit volume exceeded 6000 In 2015, the annual cumulative audit volume exceeded 6000 8482, an increase of 221% compared with 2641 in 2014 The above data can be seen that the speed of CDE completion is accelerated In 2013, the number of chemical and chemical applications was 3627, which has been on the rise In June 2014, the number of annual cumulative applications exceeded 4000 In July 2015, the number of annual cumulative applications reached the highest peak of 4977, which began to decline In 2015, the number of applications was 4609, an increase of 3.8% compared with 4440 in 2014 In 2013, the annual review volume of chemical drugs was 963, and up to October 2014, the annual cumulative review volume was less than 1000 In November 2014, the annual cumulative review volume increased to 1044, and in October 2015, the annual cumulative review volume increased to 2716, November to 4393, and 2015, the annual review volume was 6699 The first annual review volume of chemical drugs was higher than the annual declaration volume, and the annual review volume increased to 517% In terms of traditional Chinese medicine, in 2013, the number of applications was 143, and the annual review volume was 160 The annual review volume was higher than the annual application volume From January 2014 to April 2015, the annual cumulative declared amount and the annual cumulative audited amount are about 100-150 The annual cumulative audited amount and the annual cumulative declared amount in 2014 are different from each other, but usually the annual cumulative audited amount is lower than the annual cumulative declared amount In 2015, 1 Since the beginning of the month, the annual cumulative review and settlement volume is higher than the annual cumulative declaration volume, and the annual cumulative review and settlement volume keeps rising, while the annual cumulative declaration volume keeps declining In 2015, the declaration volume is down to 85, 28.6% lower than that in 2014 In 2015, the amount of traditional Chinese medicine review increased to 300 for the first time, an increase of 168% compared with 112 in 2014 Biological products biological products are the key planning categories of pharmaceutical manufacturing in the 13th five year plan According to Xianda data v3.2, the annual cumulative declaration volume of biological products has been maintained between 150 and 190 In November 2015, the highest annual cumulative declaration volume was 186 In 2013, the number of audits was 68, which has been on the rise since then In October 2014, the cumulative amount of audits increased to more than 100 In November 2015, the highest value of the cumulative amount of audits in three years was 188, which was also the first time that the cumulative amount of audits exceeded the annual cumulative declared amount However, in 2015, the annual review and settlement volume was 172 lower than the annual declaration volume of 179 In 2015, the growth rate of annual declaration volume of biological products was 17%, while the growth rate of annual review volume was 33% In 2013, the number of major special applications was 47, in 2014, the number of major special applications was 57, and the annual cumulative volume of major special applications was generally 41-66 from December 2013 to July 2015 However, since August 2015, the annual cumulative volume of major special applications dropped to less than 40, and the annual volume of major special applications in 2015 was 37 35% lower than the same period last year In 2013, the number of audit settlements was 43, and in 2014, the number of audit settlements was reduced to 39 From December 2013 to March 2015, the annual cumulative amount of major special projects never exceeded 45 In April 2015, the audit volume of major special projects exceeded 50 for the first time, and the annual cumulative audit volume exceeded the annual cumulative declaration volume for the first time After that, the overall trend of annual cumulative audit volume rose, and the audit volume in 2015 rose to 74, with an annual growth rate of 89.7% In terms of special approved varieties and special approved varieties, Xianda data v3.2 found that the annual cumulative application volume has maintained the overall steady growth with occasional twists and turns In 2013, the number of special approval applications was 144, in 2014, 162, in 2015, 179, and the annual growth rate in 2015 was 10.5% The annual review and settlement volume of special approved varieties in 2013 is 100, and the annual cumulative review and settlement volume from 2014 to March 2015 fluctuates between 110 and 85 It began to increase after April 2015 In 2015, the review and closing volume of special approved varieties rose to the highest value of 164, with an annual growth rate of 78%, but still lower than the annual declaration volume of special approved varieties In summary, from the perspective of trend, there are two different trends in review and declaration after August 2015: after the State Council proposed to solve the backlog of drug review and approval tasks in August 2015, the overall review and conclusion of CDE has greatly improved, and the number of annual cumulative review and conclusion shows an upward trend Due to the unclear approval policy, many enterprises choose to wait-and-see attitude and reevaluate their product project plans After August 2015, the annual cumulative declaration volume shows a stable and declining trend.