The State Food and Drug Administration releases 2019 drug review report

Guide: Of the 8077 drug registration applications received by the Drug Review Center, 6475 were accepted for chemical drug registration, accounting for 80.2% of all registration applications in 2019.
2019 is a landmark year in the history of drug regulatory law construction, the newly enacted Vaccine Administration Law is the world's first comprehensive vaccine management law, the newly revised Drug Administration Law is a comprehensive revision in the past 20 years, the "Vaccine Administration Law" drug management law will be the Party Central Committee, the State Council's deployment, the people's expectations, review system reform experience, in the form of the consolidation and promotion of drug approval system reform to provide a strong legal guarantee.
this year, under the strong leadership of the State Drug Administration (hereinafter referred to as the Drug Administration), the Drug Administration's Drug Review Center (hereinafter referred to as the National Administration) has earnestly studied and carried out the Drug Administration Law on Vaccine Management, continuously promoted the reform of the drug review and approval system, actively constructed a process-oriented scientific management system for drug review, adhered to the rules, open transparency, service-oriented, scientific and standardized review, and effectively ensured the safety and effectiveness of the people's health.
. First, the drug registration application acceptance situation 2019, the drug review center accepted 8082 new registration applications (including equipment combination products 5, with acceptance number, the same below), of which 6199 registration applications requiring technical review (including 4907 registration applications for technical review and administrative approval of the drug review center), direct administrative approval (no technical review, the same below) registration applications 1878. of the 8077 drug registration applications accepted by the
(i) General Situation Center, the number of applications for registration of chemical drugs was 6,475, accounting for 80.2% of the total registration applications received in 2019, and the acceptance of registration applications for various types of drugs in 2016-2019 was detailed in Figure 1.
Figure 1 Acceptance of applications for registration of various types of drugs for 2016-2019 Note: 1. The total number of registration applications accepted in 2019 is greater than the total number of applications for registration of Chinese medicine, chemical drugs and biological products in 2019;
Figure 2 The acceptance of applications for registration of various types of drugs requiring technical review for 2017-2019 2019, 6199 registration applications for technical review were accepted, an increase of 11.21% over 2018, of which 4,937 applications for registration of chemical drugs were compared to 201 In august, an increase of 10.72 per cent represented 79.64 per cent of all registration applications requiring technical review, 257 applications for registration of Chinese medicine, a decrease of 14.33 per cent compared to 2018, and 1005 applications for registration of biological products, an increase of 23.3 per cent over 2018.
the admissibility of applications for registration of chemical, chinese and biological products requiring technical review for 2016-2019, as detailed in figure 2.
Drug Review Center accepted a total of 700 applications for registration of 1 type of innovative drug (319 varieties), (the number of varieties of chemical drugs active ingredients, the number of varieties of Chinese medicine and biological products are all counted by the generic name of the drug, the same below), the number of varieties increased by 20.8% compared to 2018.
, 302 new drug clinical trials (IND) applications were accepted for 1 new drug, an increase of 26.4% compared to 2018, and 17 new drug applications (NDA) for 1 innovative drug were accepted, 8 fewer than in 2018.
(ii) The Domestic Innovative Drug Acceptance Center accepted 528 applications (244 varieties) for the registration of domestic 1 innovative drugs, of which 503 (228 varieties) were accepted for clinical applications and 25 (16 varieties) for listing.
by drug type statistics, 401 chemical drugs (144 varieties), biological products 127 (100 varieties), innovative drug indications mainly concentrated in the field of anti-tumor, anti-infection and digestive system diseases.
(iii) The Center for the Trial of Imported Innovative Drugs and Original Research Drugs accepted 157 applications (92 varieties) for the registration of imported primary research drugs of 5.1 chemical drugs, 172 applications for registration of imported innovative drugs (75 varieties), and the adaptation of innovative drugs mainly focused on anti-tumor, endocrine and neurological diseases.
(4) Acceptance of various types of registration applications 1. Chemical Drug Registration Application sheard by the Center for The Review of Chemical Drugs 6475 applications for chemical drug registration, of which 694 applications for IND chemical drugs were accepted, an increase of 51.9% over 2018; In 018, there was an increase of 21.5%, 1047 applications for generic drugs (ANDA) were accepted, an increase of 6.6% compared to 2018, and 1038 (308 varieties) were accepted for consistency evaluation supplements, an increase of 71% over 2018.
the acceptance of various registration applications for chemical drugs in 2019, as detailed in figure 3.
the acceptance of registration applications for chemical drugs IND, NDA and consistency evaluation for 2016-2019, as detailed in figure 4.
Figure 3 2019 Chemical Drug Registration Application Acceptance Figure 4 2016-2019 Registration Application selling of chemical drugs IND applications, NDA and consistency evaluation Note: The Drug Review Center has been responsible for the evaluation of the quality and efficacy of generic drugs since August 2017 (1) Domestic, imported chemical drugs IND application, NDA acceptance figure 5 2019 to accept domestic and imported chemical drugs IND application, NDA treatment field distribution in the chemical drug IND application, accept 444 applications for domestic chemical drugs IND, accept import IND applications 250.
the adaptation of the domestic chemical ind application is mainly concentrated in the field of anti-tumor, digestive system and anti-infective drugs, and imported IND application indicationisis is mainly concentrated in the field of anti-tumor, anti-infective drugs and nervous system.
the chemical drug NDA, accepted 45 domestic chemical drugs NDA, accepted the import of chemical drugs NDA 85 pieces.
the domestic chemical drug NDA's indications are mainly concentrated in the field of anti-tumor and anti-infective drugs, and the imported chemical NDA's indications are mainly concentrated in the field of anti-tumor and nervous system.
accept applications for domestic and imported chemical syds in 2019 and the distribution of NDA treatment in see Figure 5.
(2) 1 chemical drug innovation drug acceptance drug review center received 573 applications (219 varieties) of innovative chemical drugs, the number of varieties increased by 39.5% compared to 2018, of which 206 inD applications were accepted, an increase of 46.1% compared to 2018;
Figure 6 Of the 2016-2019 Chemical Drug Innovation Drug Registration Application for 219 Varieties of 1 Class Chemical Drug Innovation Drug Registration Application, the application for registration of domestic Chemical Drug Innovation Drug was 144 varieties, and the application for registration of imported Chemical Drug Innovation Drug was 75 varieties.
the acceptance of applications for the registration of innovative drugs for 2016-2019, as detailed in figure 6.
2. The Chinese Medicine Registration Application Acceptance Center accepted 423 applications for Chinese medicine registration, of which 17 applications for Chinese medicine IND, 3 cases of Chinese medicine NDA 3, and 3 cases of Chinese medicine ANDA3.
the acceptance of various types of registration applications for Chinese medicine in 2019, see Figure 7.
the acceptance of IND applications, NDA and ANDA for Chinese medicine in 2016-2019, as detailed in Figure 8.
Figure 7 The acceptance of all types of registration applications for Chinese medicine in 2019 Figure 8 2016-2019 Chinese medicine IND application, NDA, ANDA acceptance situation (1) Chinese medicine IND application acceptance in 17 Chinese medicine IND applications (5, 6, 8), the main focus of the treatment areas of adaptation is digestion, respiratory and orthopaedics, 76% of the applications for IND of Chinese medicine.
(2) Chinese medicine new drug acceptance drug review center received 5-6 categories of new Chinese medicine registration applications 18 (18 varieties, no 1-4 categories of Chinese medicine registration applications), of which 15 chinese medicine IND applications (15 varieties), Chinese medicine NDA 3 (3 varieties), compared with 2018 have decreased.
3. Biologics Registration Application Acceptance Chart 9 2019 Biological Products Registration Applications For All Types Accept1179 Applications for Biologics Registration, of which 310 applications for IND for Biological Products (7 applications for prevention of IND, treatment) 303 APPLICATIONS WITH IND), AN INCREASE OF 4% COMPARED TO 2018, AND 124 NDA RECEIVING OF BIOLOGICAL PRODUCTS (NDA7 for Preventive Use, NDA 117 for Treatment), an increase of 45.9% compared to 2018.
the acceptance of applications for registration of various types of biological products in 2019, as detailed in figure 9.
the 2016-2019 IND application and NDA acceptance of biological products are detailed in Figure 10.
Figure 10 2016-2019 IND application and NDA acceptance (1) Class I Biologics Innovative Drug Acceptance Center accepted 127 applications for registration of innovative drugs for class 1 biologicproducts (100 varieties), the number of items increased by 3.3% compared to 2018, of which 2 biological products for prevention and 125 for therapeutic biological products.
121 applications (96 varieties) for innovative biologics in category 1, an increase of 8% compared to 2018, and NDA6 (4 varieties, all therapeutic biologics), 5 fewer than in 2018.
Figure 11 2019 accepted in the treatment of 1 class of biological products IND application seisitype distribution of the drug review center received 1 class 1 treatment of biological products IND applications 119 (95 varieties), indications mainly concentrated in the field of anti-tumor treatment, accounting for all 1 treatment of biological products IND applications 69%, the specific treatment area distribution details in the figure figure 111.
II. Overall completion of drug registration application review (i) 1. The completion of the year-round review and approval 1. The drug review center in 2015-2018 through the expansion of the review channel, strengthen the review project management, large-scale recruitment, secondment of provincial bureau personnel and other measures to expand the review strength, improve the efficiency of the review, so that the drug registration application backlog has been basically resolved, the focus of the drug review center has been resolved by the drug registration backlog gradually In order to improve the time-bound review and approval rate of drug registration applications, the Pharmaceutical Review Center in 2019 achieved a time-bound review and approval rate of more than 90% for all types of registration applications for Chinese medicine, chemical drugs and biological products, and basically completed the State Council's Opinionon on Reforming the Review and Approval System for Pharmaceutical Medical Devices (No. 44 of The State Administration (2015), hereinafter referred to as Document 44, to determine the work target of achieving the prescribed time limit for approval in 2018.
a total of 8730 registration applications (including 5 device portfolio products) completed in 2019 for review and approval, of which 6,817 (including 4075 technical review and administrative approval registration applications for the drug review center) were completed for technical review and approval of the registration applications for direct administrative approval.
the number of registration applications for review and approval at the end of 2019, which were approved by review and pending review, has decreased from nearly 22,000 at the peak of September 2015 to 4,423 (excluding registration applications that have completed the review waiting for applicants to respond to additional information due to defects in the reporting information), consolidating the reform effectiveness of document 44 to address the backlog of registration applications.
4,423 registration applications for review and approval and pending review in 2019, 3334 were initiated for review, 450 were awaiting verification at the end of the review, 639 were in the process of suspending the review waiting for the associated varieties (290), waiting for the applicant to check the quality label specification packaging labelling process (235) and waiting for inspection reports (36). of the 6,817 registration applications for technical review
, 300 were for registration of Chinese medicine, 1104 for biological products, 5413 for chemical drugs registration, and about 79% of the total amount of registration of chemical drugs was completed.
2. All types of registration application review completion chart 12 2016-2019 all types of registration application review completion Note: 2019 contains 5 equipment combination products registration applications, so the total number of registration applications in 2019 in the chart is greater than the sum of chinese medicine, chemicals, biological products registration applications.
the Drug Review Center completed 1001 IND application reviews (including 1 device combination product), 270 NDA reviews (including 1 device combination product), and 1664 ANDA reviews (including 3 pharmaceutical combination products).
the completion of the review of various types of registration applications for 2016-2019, as detailed in figure 12.
3. Review 3. In 2019, the FDA review approved 926 IND applications, reviewed 926 ndA164, reviewed 260 applications for approval of oral solid formulation consistency evaluation (95 varieties by active ingredient, 107 varieties by generic name, detailed in schedule 1), and varieties increased by 66.6 6 per cent year-on-year (57 varieties) compared to 2018.
review through the listing of 10 varieties of innovative drugs in category 1, the review of the import of the original drug 58 varieties (including new indications), the specific varieties of details are detailed in Schedule s2, 3.
(ii) Completion of the review of the registration of chemical drugs 1. Overall situation figure 13 The review of various types of injection applications for chemical drugs in 2019 the review of the review of the chemical drug registration application signed by the center 5413, of which a total of 746 clinical applications for chemical drugs (IND applications and validation clinical) were completed, the chemical drugs NDA156 were completed, and the chemical and A1655 completed.
the completion of the review of various registration applications for chemical drugs in 2019, as detailed in figure 13.
2. Review of the situation map 14 2016-2019 NDA review of chemical drugs through the quantity of the number of registration applications for chemical drugs review completed the specific situation Note: "Other" means the applicant's voluntary application for withdrawal of the registration application, completion The application for registration of the request for review and improvement of the declaration information shall be submitted to the registration application of the Drug Registration management department of the National Bureau of Drug Registration, the application for registration of the combination of pharmaceutical equipment and the application for registration of raw materials/accessories with the withdrawal of the related preparations, etc. of the non-drug review center, and the same application for registration of raw materials/accessories with the withdrawal of the relevant preparations. A total of 156 ndA chemicaldrugs were reviewed by the
Drug Review Centre, of which 88 were reviewed.
2016.