The 2019 Annual Drug Review Report is officially released.

The following is the original report: 2019 is a landmark year in the history of drug regulatory law construction, the newly enacted Vaccine Management 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" will be the Party Central Committee, the State Council deployment, the people's expectations, review of the reform of the experience, in the form of the law to consolidate and promote the reform of the drug approval system provides 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.
. The acceptance of drug registration applications In 2019, the Drug Review Center accepted 8082 new registration applications (including 5 device combination products, 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), and 1878 registration applications for direct administrative examination and approval (no technical review, the same below).
(i) Of the 8077 drug registration applications accepted by the Center for Drug Review, 6475 were registered with chemical drugs, accounting for 80.2% of all registration applications in 2019, and the acceptance of registration applications for various types of drugs in 2016-2019 was detailed in Figure 1.

Figure 1 2016-2019 Acceptance of applications for registration of various types of drugs Note: 1. The total number of applications for registration of equipment combination products including 5 device combination products in the 2019 acceptance volume, so the total number of applications accepted for registration in 2019 is greater than the sum of the applications for registration of Chinese medicine, chemical drugs and biological products;

Figure 2 The acceptance of applications for registration of various types of drugs requiring technical review 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 20 In 18 years, an increase of 10.72 per cent, accounting for 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. the
Drug Review Center accepted a total of 700 applications for registration of innovative drugs in categories 1 (319 varieties), (the number of varieties of chemical drugs is based on active ingredients, the number of varieties of Chinese medicine and biological products are all counted by the generic name of the drug, the same as 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) Domestic Innovative Drugs Reception The Drug Review Center accepts 528 applications (244 varieties) for registration of domestic 1 innovative drugs, of which 503 (228 varieties) of clinical applications are accepted and 25 (16 varieties) are listed.
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) Imported Innovative Drugs and The Admission of Original Research Drugs The Drug Review Center accepts 157 applications (92 varieties) for the registration of imported primary research drugs of 5.1 chemical drugs, 172 applications (75 varieties) for registration of imported innovative drugs, and the adaptation of innovative drugs is mainly concentrated in the field of anti-tumor, endocrine and neurological diseases.
(4) Acceptance of various types of registration applications 1. Chemical Drug Registration Application Seine Registration Center accepted 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 Acceptance of registration applications for chemical drugs in 2019
Figure 4 2016-2019 Registration applications for chemical drugs IND applications, NDA and consistency evaluation: 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 applications, 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, the acceptance of domestic chemical drugs NDA 45 pieces, accept imported 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, the Drug Review Center accepted 573 applications (219 varieties) for the registration of 1 chemical drug innovation drug, the number of varieties increased by 39.5 percent compared to 2018, of which 206 indilated in indgeapplications, an increase of 46.1% over 2018;

Figure 6 2016-2019 Chemical Drug Innovation Drug Registration Application Acceptance 219 Varieties of 1 Class Chemical Drug Registration Application, domestic Chemical Drug Innovation Drug Registration Application for 144 varieties, Imported Chemical Drug Innovation Drug Registration Application for 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 situation The Chinese medicine review center accepted 423 applications for registration of Chinese medicine, of which 17 applications for Chinese medicine IND, 3 cases of Chinese medicine NDA, and 3 cases of Chinese medicine ANDA.
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 various types of registration applications for Chinese medicine in 2019
Figure 8 2016-2019 Chinese medicine IND application, NDA, ANDA intake (1) Chinese medicine IND application acceptance (1 Chinese medicine IND applications InD 17 chinese medicine IND applications (5, 6, 8), the main focus of the treatment areas of indications is digestion, respiratory and orthopaedics, Chinese medicine IND applications accounted for 76%.
(2) Chinese medicine acceptance Center accepted 5-6 categories of new Chinese medicine registration applications 18 (18 varieties, no 1-4 categories of Chinese medicine registration applications), of which 15 applications for Chinese medicine IND (15 varieties), Chinese medicine NDA 3 (3 varieties), compared with 2018 have decreased.
3. Acceptance of applications for registration of biological products
Figure 9 2019 The acceptance of applications for registration of biological products The Drug Review Center accepted 1179 applications for registration of biological products, of which 310 applications for IND for biological products were accepted (7 applications for prevention of IND, 303 IND applications for treatment, an increase of 4% compared to 2018, and 124 NDA spending on biological products (7 NDA for preventive use and 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) I biological products innovative drug acceptance Center accepted 127 applications for registration of innovative drugs for class 1 biological products (100 varieties), the number of cases 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 the
, an increase of 8% compared to 2018, and 6 NDA (4 varieties, all therapeutic biological products), 5 fewer than in 2018.

Figure 11 2019 accepted in the treatment of 1 class of biological products IND application distribution in the field of treatment Drug review center received 119 applications for 1 class of therapeutic biological products IND applications (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 of the distribution of detailed figure 11.
II. Overall completion of drug registration application review (i) 1. The completion of the review and approval for the whole year From 2015 to 2018 the Drug Review Center expanded the review strength through various channels, strengthened the review project management, large-scale recruiters, seconded provincial bureau personnel, and improved the efficiency of the review, so that the backlog of drug registration applications has been basically resolved, and the focus of the drug review center has been gradually resolved by resolving the backlog of drug registration applications 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 for review and approval completed in 2019 (including 5 products in the equipment portfolio), of which 6817 (including 4075 technical review and administrative approval registration applications of the drug-needing center) were completed for technical review and approval of the registration application, and 1908 registration applications for direct administrative approval were completed.
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.
4423 registration applications for review and approval and pending review approval 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 time pending 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 completed by the
technical review, 300 were for registration of Chinese medicine, 1104 for biological products, 5413 for registration of chemical drugs, and about 79% of the total amount of registration of chemical drugs was completed.
2. Completion of the review of all types of registration applications
figure 12 2016-2019 The completion of the review of all types of registration applications Note: The total number of registration applications for 2019 with 5 device combination products in 2019 is greater than the total number of registration applications for Chinese medicine, chemicals and biological products in 2019.
the Drug Review Center completed 1001 IND application reviews (including 1 device combination product), 270 NDA reviews (including 1 device portfolio), 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 Of 2019, the REVIEW of the Centre approved 926 IND applications, reviewed 164 NDA, reviewed 654 and 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 the number of varieties increased by 6.6 per cent year-on-year (57 varieties) compared to 2018 (57).
review through the listing of 1 0 varieties of innovative drugs, the review through the import of the original drug 58 varieties (including new indications), the specific varieties of the details are detailed in Schedule 2, 3.
(ii) Completion of the review of the registration of chemical drugs 1. General situation
Figure 13 2019 The review of various types of chemical drug injection applications completed the review of the chemical drug registration application signed by the Drug Review Center 5413 applications, of which a total of 746 clinical applications for chemical drugs (IND applications and validation clinical) were completed, 156 chemical drugs NDA 156 completed, and 1655 chemical and A.
the completion of the review of various registration applications for chemical drugs in 2019, as detailed in figure 13.
2. Review of the
Figure 14 2016-2019 NDA Review of Chemical Drugs Approved By Quantity List 1 The specific circumstances of the 2019 review of registration applications for chemical drugs
Note: "Other" refers to the applicant's voluntary application for withdrawal of registration applications, completion of the review pending the applicant to supplement the registration of the reporting information, non-drug review center review submitted to the National Bureau of Medicine.