In 2022, pharmaceutical companies will accelerate drug review

Carrying out the consistency evaluation of generic drugs can make generic drugs consistent with the original brand drugs in quality and efficacy, and can replace the original brand drugs in clinical practice; it can also save medical expenses while improving the quality of generic drugs in China and the overall development of the pharmaceutical industry level to ensure the safety and effectiveness of public medication
.
Therefore, it can be clearly seen that in recent years, the state has been encouraging the preferential procurement and use of products that have passed the consistency evaluation
.
In this context, pharmaceutical companies are also accelerating product reviews
.
The data shows that in 2021, a total of 1,965 generic drugs of 573 companies have passed the consistency evaluation or are deemed to have passed the consistency evaluation, a year-on-year increase of more than 70%
.
The time has entered 2022, and the drug consistency evaluation is still continuing
.
According to public information, 88 new consistency evaluation acceptance numbers will be added in January 2022; 150 approvals (including 57 deemed approved) have been reviewed
.
A total of 95 varieties of 97 companies were involved, of which 17 varieties were the first to be rated
.
From the point of view of the over-evaluation companies, the most over-evaluated companies in January were Nanjing Chia Tai Tianqing, Sinopharm Zhijun (Shenzhen) Pharmaceutical, Ruiyang Pharmaceutical, and Chenxin Pharmaceutical.
All of the above companies have passed the consistency evaluation for three varieties
.
It is understood that as of now, Nanjing Chia Tai Tianqing has applied for consistency evaluation of 47 varieties (including the declaration of newly registered generic drugs), and 28 varieties have been over-evaluated
.
Sinopharm Zhijun (Shenzhen) Pharmaceutical Co.
, Ltd.
has submitted 14 varieties for consistency evaluation (including the declaration of newly registered generic drugs), of which 8 varieties have been reviewed
.
Ruiyang Pharmaceutical Co.
, Ltd.
has submitted 49 varieties for consistency evaluation (including the declaration of new registration classification generic drugs), and 22 varieties have been evaluated
.
In addition, Chenxin Pharmaceutical has also applied for consistency evaluation of 30 varieties (including the declaration of newly registered generic drugs), of which 10 varieties have been over-evaluated.

.
On the whole, the industry believes that in recent years, in order to promote the consistency evaluation of generic drugs in China, a series of technical documents, guiding principles, notification announcements, etc.
, which have a guiding role in the consistency evaluation, have been issued to guide and help enterprises to pass the drug as soon as possible.
From the background of the consistency evaluation, the consistency evaluation of generic drugs in China is progressing smoothly, and the enthusiasm of pharmaceutical companies to participate in the consistency evaluation is constantly improving
.
Especially with the continuous advancement of the consistency evaluation and the reform of the drug review and approval system, after a large number of provinces and cities have suspended the listing of unreviewed drugs and lowered their prices, it is expected that more and more companies in the industry will begin to speed up the consistency evaluation work
.
However, it should be noted that industry insiders have also proposed that accelerating the promotion of generic drug consistency evaluation will also bring about a major reshuffle of China's generic drug industry, and local development will face more intense competition challenges
.
In the future, products that cannot pass the consistency evaluation may be difficult to gain market access, small and medium-sized enterprises will gradually withdraw, the market share of high-quality generic drugs will continue to increase, and the industry concentration will be improved
.
The industry suggests that for the majority of small and medium-sized pharmaceutical companies, in addition to accelerating product review, it is also necessary to deepen transformation and strengthen technological innovation as soon as possible
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.