Take stock The latest global list of approved medicines and devices in November 2020

01 FDA Approval Figure 1 Changes in FDA Drug Approvals 2010-2020 Source: FDA Figure 1, as of December 3, 2020, the FDA's official website discloses that the FDA completed 62 drug first approvals (without provisional approval), of which NDA/BLA approved 10 (not including provisionally approved drugs).
three of the drugs were newly approved new molecular entities, five were eligible for orphan drugs and four were declared on the market through 505 (b) (2).
1 November 2020 FDA Approved NDA/BLA Drug List Data Source: FDA 02 EUEMA Approval As of December 3, 2020 EMA official website disclosed that a total of 8 drugs were approved for sale in November 2020, including 4 new active substances (New active, NAS).
approvals for 2010-2020 are shown in figure 2.
Figure 2 Changes in the number of EMA drug approvals for 2010-2020 Data source: European Medicines Agency Table 2 List of drugs approved by the EMA in November 2020 Source: European Medicines Agency 03NMPA Approvals As of December 3, 2020 NMPA disclosed that a total of 26 domestically registered drugs were approved in November 2020.
According to the dosage form to weight, a total of 16 drug varieties, of which Zhengda Qing's Pomadumamine capsules, Chengdu Yuandong biological hydrochloric acid methionion slow release capsules and Qingfeng Pharmaceuticals' Lacosaamine injections are the first imitation varieties in China. the third immunomodulative inhibitor for multiple myeloma,
Pomadamine, developed and produced by The New Foundation of the United States, is the world's third most active immunomodulative inhibitor for multiple myeloma, which effectively promotes tumor apoptosis and inhibits cell proliferation, enhances the immune function of NK cells and T cells, and is by far the most active immunomodulant.
the drug was approved for listing by the FDA in February 2013, by the EMA in August 2013, and the new company submitted a clinical application and approval in November 2013, but has not yet filed a listing application.
2020 global sales of 2.235 billion U.S. dollars, a total of 20 domestic enterprises submitted clinical applications, 3 enterprises submitted applications for listing, only Zhengda Tianqing was approved for listing.
04 generic drug consistency evaluation as of December 3, 2020 CDE official website disclosed that a total of 2556 acceptance numbers for drug consistency evaluation, a total of 65 new acceptance numbers were accepted this month.
As of December 3, 2020, a total of 1799 varieties of listed drugs through the consistent evaluation (including the same pass), this month a total of 111 standard drugs through the consistent evaluation of drugs (including the same pass), according to the dosage form, a total of 65 drug varieties, including 26 varieties of drugs for the first evaluation.
This month, a total of 39 drug evaluation of the injection dosage forms, including The East China and Zhengda Tianqing have passed the annual sales of more than 1 billion heavy-weight varieties, with the consistency evaluation work gradually carried out, the consistent evaluation of injection forms has become a hot spot of enterprise competition.
number of consistent evaluations for each month of 2020 is shown in figure 3.
Figure 3: Changes in the number of approvals for generic consistent evaluation Data sources: Approval of Global Medical Devices by the State Drug Administration 01 FDA Approval As of December 3, 2020, the FDA approved a total of 226 510 (k) pathway products, including 3 devices, 214 class ii devices, and 9 unclassified.
2020 through pre-LISTING (PMA) for the first time.
By classifying 510(k) pre-market notification devices according to the use of the U.S. medical profession, it was found that the most approved types of products in November were orthopaedic devices, general and plastic surgery devices, radiological devices, cardiovascular devices and dental devices, as shown in Figure 4.
4: Distribution of types of products approved for market through fda 510(k) in November 2020 Source: FDA Table 3: PMA First Time in November 2020 Approved Devices Data Source: FDA 02 Approvals As of December 3, 2020, the National Bureau of Medicine announced 13 categories of three medical devices entering the green channel for innovation approval.
see table 4.
Table 4 Three types of innovative devices entering the green channel in November 2020 Data sources: National Medical Device Review Center Table 5 Three types of innovative medical devices approved in November 2020 Data sources: National Medical Device Review Center As of December 3, 2020, the State Bureau approved the first registration of three types of medical device products 29, of which 21 were domestically produced and 8 were imported.
approved data this month increased from the previous month, with provincial drug regulators approving a total of 797 registered second-class medical devices in China in November, and 1,296 registered medical devices in one category.
statistics show that affected by the outbreak, the largest number of infusion, nursing and protective equipment, a total of 684, accounting for 32%, are basically domestic, 671 items.
addition to infusion, nursing and protective equipment, the top three approved registration categories are in-body diagnostic reagents, clinical testing devices and physiotherapy equipment. Table
6 Distribution of the number of approved registration categories for domestic and imported medical devices in November 2020 Data sources: National Medical Device Review Center From the geographical distribution, the largest number of approvals for two or three types of registered products in November were in Guangdong Province, Jiangsu Province and Hunan Province.
see Figure 5.
figure 5: Regional distribution of approved devices in China Data sources: National Medical Device Review Center Conclusions In November 2020, the number of new drugs approved worldwide decreased, and the FDA completed the first approval of 62 drugs (without provisional approval), of which 3 drugs were newly approved new molecular entities and 5 drugs were eligible for orphan drugs.
EMA approved a total of 8 new drugs on the market, including 4 new active substances.
The newly approved drugs in China are generic drugs, including Pomadoamine capsules, Chengdu Yuandong Bio's hydrochloric acid methionine slow release capsules and Qingfeng Pharmaceuticals' Lacosaamine injections are the first generic varieties in China, generic drug consistency evaluation work carried out steadily, a number of injection forms through consistent evaluation.
medical devices, the FDA approved 2 PMA devices for the first time, affected by the domestic and foreign epidemic materials required, this month's domestic medical device approval is still concentrated in infusion, nursing and protective equipment, a total of 684 approved, accounting for 32%.
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