2020 inventory: Chongqing drug review analysis! Ranked in the national drug declaration volume top17

National drug declarations are still on the rise in 2020, with 10,321 receptions received by CDEs as of December 31, an increase of 27.7% over 2019.
is the case with chongqing drug declarations in 2020? Please look at the following detailed annual analysis of Chongqing 2020: First, 2020 CDE acceptance of Chongqing drug registration according to the latest statistics of the pharmaceutical registration and acceptance database, in 2020 CDE co-hosted Chongqing City new drug registration applications have been accepted number 83 (in terms of acceptance number, the same below), a decrease of 29 compared to 2019, accounting for only 0.8% of the total acceptance of the country.
the acceptance of drug registration applications in Chongqing from 2011 to 2020 can be found in Figure 1.
1 2011-2020 Chongqing Drug Acceptance Note: Data as of December 31, 2020 1.1 1 class of innovative drug acceptance 2020 CDE accepted 12 applications for registration of Chongqing Class 1 innovative drugs (in order to accept the number), of which 11 clinical applications, 1 supplementary application.
by drug type, 8 chemicals, 4 biological products.
1.2 Declaration of each drug type In terms of the declaration of each drug type, mainly to the acceptance of chemical drugs (to the acceptance number), of which 69 chemical drugs, 9 Chinese medicine, biological products declaration mainly from 13 onwards, in 2020 there are 5 acceptance numbers.
of drug types received in Chongqing from 2011 to 2020 can be found in Figure 2.
Figure 2 2011-2020 Chongqing Drug Type Acceptance Note: Data as of December 31, 2020 1.3 Declared Area 2020 CDE received the number of drug applications in Chongqing City (in terms of acceptance number), ranked 17th in the national provincial municipalities directly under the Central Government drug declaration.
the declarations of the provinces and municipalities in 2020 can be found in figure 3.
Figure 3 2020 CDE Provincial and Municipal Declaration Note: Data as of December 31, 2020 Let us analyze in detail the registration and evaluation of chemical, Chinese medicine and biological products.
II, chemical drugs in 2020 a total of 69 chemical drugs (in terms of acceptance number), from the application type, including: new drugs, imitation, supplementary applications, imports, import re-registration 5 categories;
2015-2020 CDE Chongqing municipal chemical drugs, imitation, supplementary applications three categories of acceptance of the details of Figure 4.
Figure 4 2015-2020 CDE Chongqing New drugs, imitation, supplementary applications three categories of acceptance Note: data as of December 31, 2020 2.1 chemical drugs 1 category of new drug declaration according to the current classification of chemical drugs registration, chemical drugs 1 category defined as: domestic and foreign are not listed innovative drugs, including new structured compounds with pharmacological effects, with clinical value of drugs.
2020, Chongqing Chemical Drugs 1 category declaration for 8 (in terms of acceptance number), all of which are Chongqing Fuyon Pharmaceutical Research Co., Ltd. declaration, declared varieties are: FCN-647 tablets, FCN-207 tablets, FCN-011 capsules, FCN-338 tablets;
2020 Chongqing chemical drugs 1 category of declaration acceptance details can be found in Table 1.
1 2020 Chongqing Chemical Drugs Category 1 Declaration Acceptance Note: Data as of December 31, 2020 2.2 Consistent Evaluation Affected by the General Trend of Consistent Batching, 2020 Chongqing consistency evaluation acceptance number declaration 28 (in terms of acceptance number), a decrease of 8 from 2019, accounting for 3.08 percent of the total number of national consistent evaluation acceptance in 2020 (to understand the specific situation, please pay attention to the pharmaceutical intelligence registration acceptance database).
2020, Chongqing enterprises consistency evaluation of the number of acceptances as detailed in Figure 5.
Figure 5 2020 Chongqing Enterprise Consistency Evaluation Acceptance Note: Data as of December 31, 2020 In this year's chemical drug consistency evaluation declaration list, Fu'an Pharmaceutical Group Qingyutang Pharmaceutical Co., Ltd. is still the first, a total of 6 acceptance numbers, followed by Peking University Pharmaceuticals, Chongqing Sanhuayu, Chongqing Huabang declaration 4 side by side second; 2: Table 2 2020 Chongqing City Consistency Evaluation Declaration Acceptance Note: Data as of December 31, 2020 3, Chinese medicine 2020 CDE-sponsored Chongqing Chinese medicine registration applications to accept a total of 9, are supplementary applications, including Taiji Group declaration 3, Tiansan Pharmaceutical 3, Chongqing Huayou Pharmaceutical 1, Chongqing Tianji Pharmaceutical Industry 1, Chongqing Core South China Sea Pharmaceutical 1.
2011-2020, Chongqing Chinese medicine declaration acceptance is detailed in Figure 6.
2020 Chongqing Chinese medicine declaration acceptance see Table 3: Figure 6 2011-2020 Chongqing Chinese medicine acceptance number Note: Data as of December 31, 2020 Table 3 2020 Chongqing Chinese medicine acceptance Note: Data as of 2 December 31, 2020 Four, biological products 2020 Chongqing a total of 5 receiving numbers were accepted by CDE, all of which are therapeutic biological products;
2013-2020, Chongqing bio-product declaration acceptance is detailed in Figure 7.
2020 Chongqing Bio-Products Declaration acceptance see Table 4: Figure 7 2013-2020 Chongqing Bio-Products Acceptance Quantity Note: Data as of December 31, 2020 Table 4 2020 Chongqing Bio-Products Acceptance Note: Data as of December 31, 2020 May, 2020 Chongqing Drug Registration Review and Approval According to the latest statistics of the Pharmaceutical Intelligence Registration and Acceptance Database, the number of acceptance numbers will be closed in 2020 (January 1, 2020 to December 31, 2020) (refers to the number of varieties that CDE has completed technical review and handed over for approval, and the status of processing includes approval, approval or certification completion, in terms of acceptance number) totalling 69.
addition, there are 12 clinical trials implied license acceptance number, the default approval of clinical (for specific information, please pay attention to the pharmaceutical registration acceptance database).
2020, the conclusion of various drug types in Chongqing city is detailed in Figure 8.
Figure 8 Review of Drug Types in Chongqing, 2020 Note: Data as of December 31, 2020 12 of the 81 review closing numbers have been approved, including: Chongqing Re-creation Pharmaceutical Research Co., Ltd., a class 1 new drug FKN-338 Tablets, Southwest Pharmaceutical Co., Ltd.'s improved new drug hydrochloric acid morphine slow release tablets, etc., approved the production of 13, including Chongqing Sanhua Pharmaceutical Co., Ltd. injection of sodium crea acid, Chongqing Lemie Pharmaceutical Co., Ltd. injection of methionyl nylon sodium oxide, etc. (for specific information, please pay attention to the pharmaceutical registration and acceptance database).
2020 Chongqing drug registration approval clinical and approved production details can be found in Table 5.
5 2020 Chongqing City approved clinical/approved production