New developments in consistency evaluation: injections have been well received, 19 drugs have been reviewed for the first time, and 5 injections have helped centralized procurement

Introduction:

• The acceptance number of CDE consistency evaluation undertaking reached 2861, and 41 injections were newly undertook this month

• 2199 product regulations nationwide passed the consistency evaluation, and 101 injections were added this month

• 19 drugs have been reviewed for the first time, involving 8 systemic anti-infectives

• Kelun, Yichang Renfu.

  
  

The acceptance number of CDE consistency evaluation undertaking reached 2861, and41 injections were newly undertook this month

As of the end of March 2021, CDE has undertaken a total of 2,861 conformity acceptance numbers, including 1,201 injections

Figure 1: Overview of CDE Consistency Evaluation Contractors Data source: Yaorongyun China Drug Evaluation Database

2199 product regulations nationwide passed the consistency evaluation, and101 injections were added this month

According to the Yaorong Cloud database, as of the end of March 2021, a total of 2,199 product regulations nationwide have been evaluated, involving 519 varieties

  19 drugs have been reviewed for the first time,

  Involving 8 systemic anti-infectives  

Among the 43 injection formulations approved this month, 19 were the first to be reviewed.
From the perspective of the therapeutic fields of these drugs, the most reviewed are systemic anti-infectives, followed by antitumor drugs and immune function modulators
.

Table 2: List of the first approved drugs for injections this month

Data source: Yaorongyun consistency evaluation database

Figure 2: The proportion of the first over-evaluated drug treatment field for injections this month.
Data source: Yaorongyun consistency evaluation database

  Kelun, Yichang Renfu.
.
.
Injections have been reviewed,

  5 injections to help centralized procurement  

Among the 101 injections that passed the consistency evaluation, 58 companies were involved
.
According to the statistics of the consistency evaluation database of Yaorongyun, the overview of the number of companies that passed the consistency evaluation this month is as follows
.
Sichuan Kelun Pharmaceutical and Yichang Renfu Pharmaceutical have passed the consistency evaluation with the largest number of varieties, reaching 3
.
Among them, 7 varieties were gathered to three by the number of manufacturers this month to help centralized procurement
.

Table 3: The data source of the three reviewed varieties collected this month: Yaorongyun consistency evaluation database