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

Global Drug Approval 01 FDA Approval Figure 1: Changes in FDA Drug Approval Numbers 2008-2020 Source: FDA Figure 1, as of October 10, 2020, the FDA website discloses that the FDA completed 90 drug first approvals (not including provisional approvals), of which NDA/BLA approved 7 (not including 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 September 2020 Source: FDA 02 EUEMA 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 Data source: European Medicines Agency Table 2: List of drugs approved by the EMA in September 2020 Source: European Medicines Agency 03NMPA Approvals As of October 10, 2020, NMPA disclosed that 30 domestically registered drugs were approved for the first time 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, a total of 20 varieties were evaluated through generic drug conformity, of which 14 varieties were adopted as if they were classified as class 3,4,5.2 oral solids and injections according to the new registration, and if adopted, subsequent generics conformity evaluation would not be required.
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, under the continuous improvement of relevant policies, pharmaceutical companies are stepping up the consistent evaluation of generic drugs.
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 October 10, 2020, the FDA approved a total of 248 510 (k) pathway products, including 11 for class I devices, 227 for Class II devices, and 9 for non-classification.
2020, a total of one was listed for the first time through pre- LISTING approval (PMA).
by classifying 510(k) pre-market notified 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 of approved product types through fda 510(k) in September 2020 Source: U.S. Food and Drug Administration Table 3: Device Data first approved by PMA in September 2020 Source: U.S. Food and Drug Administration 02 Domestic Approval As of October 10, 2020, in September 2020, the State Administration approved the first registration of three types of medical device products 20, of which 11 were domestic and 9 were 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 epidemic at home and abroad, 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
: Distribution of the number of approved registration categories for domestic and imported medical devices in September 2020 Data source: State Administration of Drug Administration from the geographical distribution, in September, the second and third categories of domestic registered product approvals were the largest in Guangdong Province, Hunan Province, Jiangsu Province, three regions.
see Figure 5.
Figure 5: Regional Distribution of Approved Devices In China Data 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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