11 charts at a glance

Author: Mao Qiqiong

In October 2021, the number of new drugs approved globally remains stable

In terms of medical devices, the FDA has 3 medical devices listed through the pre-market approval (PMA) route; domestic medical device approvals are concentrated in in vitro diagnostic reagents, and a total of 500 items have been approved, most of which are domestically produced (490 items)

01 Global drug approval status

(1) Approval by the US FDA

Figure 1: Changes in the number of FDA drug approvals from 2008 to 2021

Source: U.

As of November 3, 2021, the FDA official website disclosed that in October 2021, the FDA has completed 57 first drug approvals (not including temporary approvals), of which 10 new drug applications (NDA)/biological product marketing authorization applications (BLA) have been approved ( Excluding provisional approval), see Table 1

Four of these drugs are used for ophthalmology-related diseases

Table 1: List of NDA/BLA drugs approved by the FDA in October 2021

Source: U.

(2) EU EMA approval status

As of November 3, 2021, the official website of EMA disclosed that the number of recommended drugs and new active substances (NAS) for the market from 2012 to October 2021 is shown in Figure 2

Figure 2: Changes in the number of drugs recommended by the EMA for marketing from 2012 to 2021 (pieces)

Source: Flint Creation Database

(3) NMPA approval status

As of November 3, 2021, NMPA disclosed that in October 2021, a total of 28 domestic first-registered drugs were approved

Table 2: List of approved Class 1 new drugs approved by NMPA

Source: State Drug Administration

Chengdu Microchip Pharmaceutical Co.

(4) Consistency evaluation of generic drugs

As of November 3, 2021, the official website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration disclosed that CDE has undertaken a total of 3,406 drug consistency evaluation acceptance numbers, and a total of 74 new acceptance numbers have been contracted in October 2021

At present, there are a total of 914 product specifications (167 varieties) of injections that have passed the consistency evaluation, and a total of 46 product specifications (25 varieties) of injections have been reviewed this month

Figure 3: Changes in the number of approvals for consistency evaluation of generic drugs from 2020 to October 2021 (units)

Source: State Drug Administration

02 Global medical device approval status

(1) Approval by the US FDA

As of November 3, 2021, the FDA has approved a total of 232 510(k) route products in October, of which 20 are Class I devices, 205 are Class II devices, and 7 are unclassified

After categorizing the 510(k) pre-market notification devices according to the medical professional use in the United States, it was found that the most approved types of products in October were general hospital and personal use devices, general and plastic surgery devices, orthopedics devices, and radiology.

Figure 4: Distribution of product types approved for marketing through the FDA 510(k) route in October 2021

Data source: U.

In October 2021, there were 3 initial listings through the pre-market approval (PMA) route, as shown in Table 3

Table 3: Devices approved by PMA for the first time in October 2021

Source: U.

(2) Domestic approval

As of November 3, 2021, in October 2021, the State Administration has announced that 11 Class III medical devices have entered the green channel for innovation approval, as shown in Table 4
.

Table 4: Three types of innovative devices entering the green channel in October 2021

Source: National Medical Device Evaluation Center

As of November 3, 2021, in October 2021, the State Administration has announced that 3 Class III innovative devices have been approved for marketing, as shown in Table 5
.

Table 5: Three types of innovative devices approved for marketing in October 2021

Source: National Medical Device Evaluation Center

As of November 3, 2021, in October 2021, the State Administration has approved a total of 85 third-class medical device products for the first registration, of which 69 are domestically produced and 16 are imported
.
In October, the provincial drug regulatory authorities approved a total of 411 domestic Class II medical devices and 898 Class I registered medical devices
.

Statistics show that the number of in vitro diagnostic reagents is the largest, with a total of 500 items, accounting for 35.
11%, basically all domestically produced, at 490 items
.
Except for in vitro diagnostic reagents, the top three approved registration categories are infusion, nursing and protective devices, physical therapy devices, and clinical testing devices
.

Table 6: Distribution of the number of domestic and imported medical devices approved and registered in October 2021

Source: National Medical Device Evaluation Center

In terms of geographic distribution, in October 2021, the three regions with the largest number of domestically produced second and third types of registered product approvals were Jiangsu Province (92), Guangdong Province (88), and Hunan Province (69), as shown in Figure 5
.

Figure 5: Regional distribution of domestically approved devices

Source: Flint Creation Database