CDE work efficiency from priority review

Source: Sina Pharmaceutical News 2017-03-22 document efive 2016 is the year of replacement of new and old policies for drug registration In general, in 2016, CDE undertook 3636 new drug registration applications with acceptance numbers How efficient is CDE in terms of priority review procedures for drugs? The author of this paper will let you know that the State Food and Drug Administration issued a notice on July 31, 2015 (No 140, 2015) asking for some policy opinions on speeding up the resolution of the backlog of drug registration applications, and the State Council issued an opinion on reforming the review and approval system of medical devices on August 18, 2015 (GF [2015] No 44) On November 11, 2015, the State Food and Drug Administration issued a notice on several policies of drug registration review and approval (No 230, 2015) On November 13, 2015, the State Food and Drug Administration issued a notice on Soliciting Opinions on solving the backlog of drug registration applications and implementing the priority review and approval (Draft) (No 227, 2015) On January 29, 2016, the drug review center issued the announcement on the basic principles of the evaluation of the application for priority review and approval of children's drug use and the first batch of priority review varieties On February 26, 2016, the State Food and Drug Administration issued the opinions on solving the backlog of drug registration applications for priority review and approval (sfjyhg [2016] No 19), which stipulated the scope of priority review and approval As of March 3, 2017, a total of 14 batches of 141 projects have been included in the priority review procedure since the notice on submitting the "application form for priority review and approval" was issued on February 29, 2016 Since the State Food and Drug Administration issued the opinion on solving the backlog of drug registration applications for priority review and approval on February 26, 2016, CDE has launched a priority review In terms of the number of publicity items, the number of 7, 10, 11 and 13 batches of publicity items is more than or equal to 15 In terms of the publicity frequency, in July 2016, the number of priority review publicity items was released for 4 times, 39 items; in April 2016, the number of priority review publicity items was released for 3 times, 14 items Note: API and preparation are one project; among the 14 batches of 141 projects with different preparation types, 27 are domestic, 51 are domestic, 29 are imported and 34 are imported It shows that CDE encourages more domestic drugs to apply for listing and provides services for domestic enterprises to quickly put drugs on the market On March 17, 2017, the State Food and Drug Administration issued a notice to solicit opinions on the decision of the State Food and Drug Administration on adjusting matters related to the registration and management of imported drugs (Draft for comments) The policy is being adjusted to accelerate the listing of imported drugs, benefiting the Chinese people PS blessed are the Chinese people who can drink the first global new drug As can be seen from the figure above, the number of chemical drugs included in the priority review process in the 14 batches is 118, followed by 21 biological drugs, and the number of traditional Chinese medicine is at least 2 It can be seen that chemical drugs are still the main force of drug declaration Note: there are multiple priority review reasons for the same project According to the separate statistics of the projects based on the priority review reasons, the clinical advantages, the first imitation, viral hepatitis, the drugs applying for the priority review procedure and the children's drugs are in the top position Each applicant can see what kind of path from it, and it depends on their own ability The applicants with more than or equal to two priority review items are as follows: the applicants with more priority review items are Hengrui medicine, Qilu, Zhengda Tianqing, Bayer, bringer Ingelheim, EBV, Novartis and Roche Priority review items in terms of application: the first batch is approved within 162 working days after it is released on March 5, 2016, the second batch is approved within 13 working days after it is released on April 18, 2016, the third batch is approved within 212 working days after it is released on April 24, 2016, the fourth batch is approved within 169 working days after it is released on April 28, 2016, the fifth batch is approved The sixth batch is approved within 92 working days after it is issued on June 12, 2016, the seventh batch is approved within 84 working days after it is issued on July 6, 2016, the fifth batch is approved within 54 working days after it is issued on July 21, 2016, the eighth batch is approved within 144 working days after it is issued on July 21, 2016, the ninth batch is approved within 72 working days after it is issued on July 21, 2016, the tenth batch is approved The 11th batch will be approved in 51 working days as soon as it is issued on September 14, 2016, the 29th working day as soon as it is issued on October 28, 2016, and the 12th batch, the 13th batch and the 14th batch as soon as it has been approved in the 12th batch (88 working days) before March 7, 2017 It can be seen from the publicity of 14 batches that CDE is conducting priority review for newly reported projects more and more quickly, which shows that after nearly a year's efforts, CDE has stepped up to a new era, and has put on 113 priority review projects of "skateboarding shoes" in 2016, and has issued 52 approvals The play begins Let's see the efficiency of our big boss - CDE: Note: as of March 13, according to the statistics of the time when the first project in each public batch has been approved, the last three batches have not been approved Why it will take a long time to get the approval documents for priority review, meanwhile, it shows that there are many areas for applicants to improve According to the information published on CDE website and the statistics of drug intelligence website, if there is any statistical omission or incompleteness, please criticize and correct