10 charts in the monthly report, a quick overview of the latest approvals of global pharmaceutical devices in January

In January 2022, the global approval rate of new drugs slowed down slightly

For medical devices, the FDA has no products that were first marketed through the premarket approval (PMA) pathway

01Global drug approvals

(1) US FDA approval

Figure 1: Changes in the number of FDA drug approvals from 2010 to January 2022 Source: US Food and Drug Administration

As shown in Figure 1, as of February 15, 2022, the FDA’s official website disclosed that in January 2022, the FDA had completed a total of 69 first-time approvals (excluding provisional approvals), of which 8 were approved by NDA/BLA (excluding provisional approvals), see table 1

Table 1: List of FDA-approved NDA/BLA drugs in January 2022

Source: U.

(2) EU EMA approval

As of February 15, 2022, the EMA official website disclosed that the number of recommended drugs and new active substances (NAS) from 2012 to January 2022 is shown in Figure 2

Figure 2: Changes in the number of drugs recommended by EMA from January 2012 to 2022 Source: Firestone Creation Database

As of February 15, 2022, the EMA has authorized 6 new medicines in January, as shown in Table 2

Table 2: List of EMA Authorized Medicines for January 2022

Source: Flint Creation Database

(3) NMPA approval

As of February 15, 2022, NMPA disclosed that in January 2022, a total of 91 domestically-produced first-time registered drugs were approved

Table 3: Approved List of Class 1 Innovative Drugs Approved by NMPA

Source: State Drug Administration

Icaritin (Acoradine)/Icaridin (Acoradine) Soft Capsules is a first-in-class Chinese medicine (first-in-class) developed by Beijing Shennuoji Pharmaceutical Technology Co.

(3) Consistency evaluation of generic drugs

As of February 15, 2022, CDE's official website disclosed that CDE has undertaken a total of 3,687 drug consistency evaluation acceptance numbers, and in January 2022, a total of 88 new acceptance numbers have been undertaken

Figure 3: Changes in the number of generic drug consistency evaluation approvals from 2018 to January 2022 Source: State Drug Administration

02Global medical device approvals

(1) US FDA approval

As of February 15, 2022, the FDA approved a total of 237 510(k) products in January, including 18 Class I devices, 216 Class II devices, and 3 unclassified

Figure 4: Distribution of product types approved through the FDA 510(k) pathway in January 2022 Source: US Food and Drug Administration

There are no products first marketed through the premarket approval (PMA) pathway in January 2022

(2) Domestic approvals

As of February 15, 2022, in January 2022, the National Bureau has not announced that the three types of medical devices have entered the green channel for innovation approval

Source: National Center for Medical Device Evaluation

As of February 15, 2022, in January 2022, the State Administration approved a total of 175 Class III medical device products for the first registration, of which 152 were domestically produced and 23 were imported

Source: National Center for Medical Device Evaluation

In terms of geographical distribution, in January 2022, the three regions with the most approvals for domestically produced second- and third-class registered products were Hunan Province (275 cases), Guangdong Province (189 cases), and Jiangsu Province (185 cases), as shown in Figure 5

Figure 5: Regional distribution of domestically approved devices Source: Firestone Creation Database