Analysis Report on Consistency Evaluation of Generic Drugs in 2021

In 2015, the State Council issued the "Opinions on Reforming the Review and Approval System for Drugs and Medical Devices", which clearly pointed out the goal of improving the quality of generic drugs
.
In recent years, the drug regulatory authorities have attached great importance to the quality and efficacy consistency evaluation of generic drugs (hereinafter referred to as the consistency evaluation), and the number and coverage of over-evaluated drugs have increased significantly, and the "running" has accelerated
.
In 2021, the consistency evaluation work will be steadily advanced, and the results will be obvious
.
Based on the relevant data from the website of the State Food and Drug Administration and the Yaorong Cloud database, this paper analyzes the consistency evaluation situation in 2021 and finds that a total of 1,972 generic drugs of grades passed the consistency evaluation (including those classified according to the new registration of chemical drugs).
895 approved generic drugs), involving 571 pharmaceutical companies and 532 drug varieties, of which 264 drug varieties are the first to be reviewed
.
The number of supplementary applications is decreasing year by year.
Enterprises focus on the application of new registration classification drugs and analyze the consistency evaluation of supplementary applications and new registration classification applications in the past three years.
From 2019 to 2021, the Center for Drug Evaluation of the State Food and Drug Administration will continue to evaluate supplementary applications and new registrations.
The situation of classified applications (generic drugs category 3/4 and imported drugs category 5.
2) shows a completely opposite trend (see Figure 1 for details), and the number of supplementary applications continues to decline.
A total of 891 applications will be accepted in 2021, while the number of new registration category applications continues to Rising, reaching 1,843 items in 2021, a year-on-year increase of 63.
39%
.
It can be seen that the focus of generic drug companies has begun to shift, from focusing on the consistency evaluation of listed drugs before the implementation of the new registration classification to focusing on the development of new generic drugs with high-quality standards
.
The proportion of over-evaluated drugs for injections has increased significantly, and the competition in the industry has become more intense.
From the perspective of over-evaluated drug dosage forms, injections are the main dosage forms of drugs that have passed the consistency evaluation in 2021, with a total of 879 product specifications, accounting for 44.
57%; followed by tablets, with a total of 44.
57%.
824 product specifications, accounting for 41.
79% (see Figure 2 for details)
.
In the past three years, the proportion of injections in over-evaluated drug formulations has also shown a continuous upward trend, from 5% in 2019 to nearly 45% in 2021 (see Figure 3 for details)
.
From the perspective of enterprise over-evaluation, in 2021, a total of 571 drugs declared by enterprises have passed the consistency evaluation.
Among them, the company with the largest number of over-evaluated drug varieties is Qilu Pharmaceutical Co.
, Ltd.
, which has over-evaluated a total of 34 drug varieties (see Figure 4 for details).

.
Judging from the number of companies that have passed the consistency evaluation of the same product, the drug product with the largest number of companies passing the consistency evaluation in 2021 is omeprazole sodium for injection, and a total of 24 companies have passed the consistency evaluation (see Figure 5 for details)
.
This variety is in the 2018 edition of the National Essential Drug List and the 2020 National Medical Insurance Category B variety.
It is used in the treatment of duodenal ulcer, gastric ulcer, reflux esophagitis and Zollinger-El lison syndrome.
, alternative therapy when oral therapy is not appropriate
.
Omeprazole sodium for injection has been in clinical application for more than 20 years so far, with definite curative effect, high safety, large market scale, and obvious pharmacoeconomic advantages.
Therefore, the competition of over-evaluation enterprises for this variety is relatively fierce
.
The "Opinions on Carrying out Consistency Evaluation of the Quality and Efficacy of Generic Drugs" issued in 2016 clarifies that the drug varieties that have passed the consistency evaluation will not be paid in terms of medical insurance payment.
With proper support, medical institutions should give priority to procurement and use in clinical practice
.
If there are more than three production enterprises that pass the consistency evaluation of the same variety of drugs, the varieties that have not passed the consistency evaluation will no longer be selected for centralized drug procurement
.
In addition, the "Implementation Opinions on Expanding the Regional Scope of the National Organization of Centralized Drug Procurement and Use Pilots" issued in 2019 pointed out that the quality of generic drugs is in principle based on the consistency evaluation of quality and efficacy
.
Consistency evaluation has become the basic threshold for shortlisted generic drugs to be purchased with volume
.
Among the over-evaluated drugs in 2021, a total of 252 drugs of different specifications were included in the national drug collection list, accounting for 12.
78%
.
Among them, 218 medicines were included in the fifth batch of national drug collection list, and 34 were included in the fourth batch of national medicine collection list (see Figure 6 for details)
.
In 2021, the smooth progress of the evaluation of the quality and efficacy of generic drugs will provide strong support for the national centralized drug procurement
.
(Wang Wenhao, Public Opinion Monitoring Center of China Health Media Group)