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    Home > Medical News > Medical World News > Take stock. The latest global list of approved medicines and devices in September 2020.

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

    • Last Update: 2020-10-22
    • Source: Internet
    • Author: User
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    In September 2020, the number of new drugs approved by the United States and the European Union increased, and all newly approved drugs on the domestic market are generics.
    the largest number of domestic medical devices approved is still related to the outbreak of protective medical devices, accounting for 34.9%.
    Global Drug Approval 01 FDA Approval Figure 1: Changes in FDA Drug Approval Numbers for 2008-2020 Source: FDA Figure 1, as of October 10, 2020, the FDA's official website discloses that the FDA completed a total of 90 drug first approvals (not including provisional approvals), of which NDA/BLA approved 7 (not temporary drugs).
    four of these drugs were designated as orphan drugs and three drugs were declared at 505 (b) (2), accounting for 42.9 per cent and 57.1 per cent, respectively.
    and 505 (b) (2) remain the focus of the declaration.
    Table 1: FDA Approval of NDA/BLA Drug List Data for September 2020 Source: FDA 02 EU EMA Approval As of October 10, 2020 EMA Official Website Discloses that a total of 5 drugs were approved for market in September 2020, of which new activity Substance (New active substance, NAS) 2, of which Avapritinib is the first targeted therapy in the European Union for patients carrying PDGFRA D842V mutation GIST, which has been submitted to CDE by Keystone Pharmaceuticals in April this year and has been eligible for priority review.
    Figure 2: Changes in the number of EMA drug approvals for 2010-2020 Source: European Medicines Agency Table 2: List of drugs approved by the EMA in September 2020 Source: 03NMPA Approvals of the European Medicines Agency as of October 10, 2020 NMPA disclosed that a total of 30 domestically registered drugs were approved in September 2020.
    weighted by dosage form, a total of 16 drug varieties.
    no new drugs have been approved this month.
    04 generic drug consistency evaluation as of October 10, 2020 NMPA disclosed that in September 2020 through generic drug consistency evaluation of 20 varieties, of which 14 varieties are adopted as the same, as by means of a new registration of chemical drugs classified as 3,4,5.2 classes of oral solid preparations and injections, if the same pass, then the follow-up will not need to do generic drug conformity evaluation.
    As can be seen from Figure 3, a total of 498 varieties will be evaluated by generic consistency in 2020, compared with previous years, the number of drugs evaluated by generic drug consistency is gradually increasing trend, and pharmaceutical companies are stepping up the evaluation of generic drugs under the continuous improvement of relevant policies.
    Figure 3: Data on changes in the number of generic consistent evaluation approvals Source: Approval of Global Medical Devices by the State Drug Administration 01 FDA Approvals as of October 10, 2020, and FDA approvals for 248 510 (k) pathways in September 2020, including 11 first-class devices, 227 class II devices, and 9 unclassified products.
    2020, a total of one was listed for the first time through pre- LISTING approval (PMA).
    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 September were orthopaedic surgery, radiology and cardiovascular, as shown in Figure 4.
    4: Distribution data on the types of products approved for market through the FDA 510(k) in September 2020 Source: U.S. Food and Drug Administration Table 3: Device Data First Approved by the PMA in September 2020 Source: U.S. Food and Drug Administration 02 domestic approval as of October 10, 2020, in September 2020 the State Bureau approved the first registration of three types of medical device products 20, of which 11 domestic and 9 imported.
    based on the continuous resumption of work and re-production throughout the country, provincial drug regulatory departments approved a total of 995 registrations of the second category of medical devices in China in September, and 1682 medical devices for the record.
    Affected by the materials needed for the domestic and foreign outbreaks, medical device approval is still concentrated in injection, nursing and protective equipment, a total of 973 items were approved this month, accounting for 34.9%, the approval of the main category of medical personnel protective supplies, operating room infection control supplies and other medical devices to control the spread of the virus.
    addition to infusion, nursing and protective equipment, other medical devices related to the outbreak, such as in-body diagnostic reagents, physiotherapy equipment, clinical testing equipment, etc. Table
    4: Data on the distribution of the number of approved registration categories for domestic and imported medical devices in September 2020: The State Administration of Drug Administration, from the geographical distribution, in September, the largest number of approvals for the second and third categories of registered products in China were in Guangdong Province, Hunan Province and Jiangsu Province.
    see Figure 5.
    Figure 5: Data on the regional distribution of approved devices in China Source: State Drug Administration Conclusion In September 2020, the number of new drugs approved by the United States and the European Union increased, and all newly approved drugs approved in China were generic drugs.
    fda completed a total of 90 drug first approvals (without provisional approval);
    approved 1 PMA device for the first time in September, affected by the materials needed for domestic and foreign outbreaks, medical device approval this month is still concentrated in injection, nursing and protective equipment, this month a total of 552 approved, accounting for 35.7%.
    .
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