Pharmaceutical News | The latest global list of approved drugs and devices in April

In April 2021, the number of new drugs approved globally has increased.

01

Global drug approval status

(1) Approval by the US FDA

Figure 1: Changes in the number of FDA drug approvals from 2010 to 2021

Source: U.

As shown in Figure 1, as of May 6, 2021, the FDA official website disclosed that in April 2021, the FDA had completed 59 first drug approvals (not including provisional approval), of which 5 were NDA/BLA approved (not including provisional approval).

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

Source: U.

(2) EU EMA approval status

As of May 6, 2021, the official website of EMA disclosed that there were 3 drugs approved for marketing in April 2021, including 1 new active substance (NAS).

Figure 2: Changes in the number of EMA drug approvals from 2010 to 2021

Source: European Medicines Agency

Table 2: List of drugs approved by EMA in April 2021

Source: European Medicines Agency

(3) NMPA approval status

As of May 6, 2021, NMPA disclosed that in April 2021, a total of 84 domestic first-registered drugs were approved.

Table 3: List of first generic drugs approved by NMPA in April 2021

Source: State Drug Administration

(4) Consistency evaluation of generic drugs

As of May 6, 2021, the CDE official website disclosed that a total of 2,960 acceptance numbers for drug consistency evaluation have been undertaken, and a total of 60 new acceptance numbers have been accepted this month.

A total of 79 product specifications (54 varieties) of injection formulations have been reviewed this month.

Figure 3: Generic drugs from 2020 to April 2021

Changes in the number of approvals for consistency evaluation

Source: State Drug Administration

02

Global medical device approval status

(1) Approval by the US FDA

As of May 6, 2021, the FDA has approved a total of 259 510(k) route products in April 2021, including 8 Class I devices, 239 Class II devices, and 12 unclassified devices.

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 April were general and plastic surgery devices, orthopedics devices, radiology devices, and cardiovascular devices, as shown in Figure 4.

Figure 4: Passing the FDA 510(k) route in April 2021

Distribution of approved product types

Source: U.

Table 4: Devices approved for the first time by PMA in April 2021

Source: U.

03

Domestic approval

As of May 6, 2021, in April 2021, the State Administration has announced that 8 Class III medical devices have entered the green channel for innovation approval.

Table 5: Three types of innovative devices entering the green channel in April 2021

Source: National Medical Device Evaluation Center

As of May 6, 2021, in April 2021, the State Administration has announced that 3 innovative medical devices of the third category have been approved for listing.

Table 6: Innovative medical devices approved for marketing in April 2021

Source: National Medical Device Evaluation Center

As of May 6, 2021, in April 2021, the State Administration approved a total of 74 third-class medical device products for the first registration, of which 58 were domestically produced and 16 were imported.

Statistics show that the number of in vitro diagnostic reagents is the largest, with a total of 679 items, accounting for 30.

Table 7: Domestic and imported medical devices in April 2021

Distribution of the number of approved registration categories

Source: National Medical Device Evaluation Center

In terms of geographical distribution, the three regions with the most approvals for the second and third categories of registered products in April were Hunan Province, Guangdong Province and Jiangsu Province.
See Figure 5.

Figure 5: Regional distribution of approved devices in China

Source: National Medical Device Evaluation Center

summary

In April 2021, the number of new drugs approved worldwide has increased.
The FDA has completed 59 first drug approvals (not including provisional approvals), of which 2 drugs are newly approved new molecular entities.
Two cell therapy drugs have been approved for marketing.
EMA approved a total of 2 new drugs for marketing, including 1 new active substance.

The newly approved drugs in China are all generic drugs, and a number of blockbuster first generic drugs have been approved for marketing.
The consistency evaluation of generic drugs has been carried out steadily.
With the development of the consistency evaluation of injection formulations, more and more injections will be included in the scope of volume procurement.

In terms of medical devices, the FDA approved 2 PMA devices for the first time.
This month, domestic medical device approvals focused on in vitro diagnostic reagents.
A total of 679 items were approved, accounting for 30.
9%.