In November, more than 40 drug registration certificates have been cancelled

On November 16, the State Food and Drug Administration issued an announcement stating that in accordance with Article 83 of the Drug Administration Law and other relevant regulations, the Food and Drug Administration has decided to stop the treatment of pediatric phenol Amin Granules, Aminophena tablets, and compound prescriptions from now on.
The production, sales, use, and cancellation of 8 varieties of aminopyrine theophylline tablets, amrinol capsules, aminoglycol tablets, bufenac cream, pediatric compound aspirin tablets, and aminofibrol tablets in China, and cancelled Drug registration certificate
.
Coincidentally, on November 4, the State Drug Administration just issued the "Announcement on the Cancellation of 34 Drug Registration Certificates including Mercury Bromine Solution (2021 No.
132)" notice
.
According to the "Announcement", in accordance with the relevant provisions of the "Regulations on the Implementation of the Drug Administration Law" and the "Administrative Measures on Drug Registration", the State Food and Drug Administration has decided to cancel 34 drug registration certificates including amalgam solution
.
These 34 drugs involve 4 dosage forms: solution, tablet, cream, and aerosol.
In addition to mercury bromide solution, glucose injection, oxytetracycline tablets, analgin tablets, and chlorpheniramine maleate Tablets and other drugs are also on the cancellation list
.
Among them, it is worth mentioning that Analgin has actually been issued many policies to restrict the use of its products
.
For example, on September 4, 1982, the former Ministry of Health issued the "Notice on Announcement of Elimination of 127 Drugs".
In this list of eliminated drugs, "Compound Analgin Tablets" were eliminated in the same batch
.
On March 17, 2020, the National Medical Products Administration issued the "Announcement on the Cancellation of Drug Registration Certificates for Analgin Injections and Other Drugs" (No.
29 of 2020) and the "Regulations on Revising the Instructions for Related Products of Analgin" Announcement (No.
34 of 2020), which also requires the production, sales and use of Analgin injection in China to be stopped.
The manuals for the recent films and other varieties were revised
.
In this regard, the industry believes that in recent years, especially since this year, the State Drug Administration has actually issued multiple announcements on the cancellation of drug registration certificates
.
This is the general trend caused by the survival of the fittest under the in-depth progress of the consistency evaluation work
.
It is understood that, for a long time, my country’s generic drug industry has always had low concentration and serious approval documents.

.
Among the existing 189,000 drug approvals, 95% are generic drug approvals, and pharmaceutical companies are almost dominated by generic drugs
.
However, this situation has also caused a large number of low-level redundant construction in the pharmaceutical market, serious homogenization competition, and very low utilization rate of pharmaceutical product production capacity
.
Therefore, in recent years, the policy environment of the pharmaceutical industry has continued to change, driven by stricter supervision, drug bidding, medical insurance control fees, consistency evaluation, and volume purchases, and more and more drugs that are not effective and unsafe have begun to be accelerated.
Retirement
.
In this context, the industry expects that the concentration of the pharmaceutical industry will further increase under the continuous changes in the domestic pharmaceutical market
.
At the same time, the "elimination competition" of the pharmaceutical industry is expected to accelerate, and a large number of drug registration certificates will also be cancelled
.