More than 600 drugs delisted in a single year, the highest number is 90!

In the era of accelerated elimination of generic drugs, it has become a common phenomenon in the industry that pharmaceutical companies take the initiative to cancel drug approvals.

A few days ago, the State Food and Drug Administration issued the "Announcement on the Cancellation of 226 Drug Registration Certificates including Bromelain Enteric-coated Tablets", and 226 drugs are facing delisting.

Why do pharmaceutical companies actively choose to cancel approval documents?

Affected by factors such as mass procurement, comprehensive promotion of consistency evaluation of drugs and injections, large-scale withdrawal of unreviewed products, excessive repetition of catalog "warnings", and reshaping of the market structure, more drugs will face reshuffle in the future.

01 Excessive competition, high-volume procurement, and consistency evaluation are forced

90! Jiangsu Huanghe Pharmaceutical Co.

With the introduction of consistency evaluation, whether or not to pass the evaluation has become a survival issue for pharmaceutical companies.

This means that conducting consistency evaluation is a compulsory course for pharmaceutical companies to retain drug approvals.

Among the delisted drugs announced this time, 4 companies have applied for the cancellation of drug approvals for multiple specifications of the hypertension treatment drug captopril tablets.

In the third batch of centralized procurement conducted in August last year, the captopril film entered the era of "points" pricing.

Obviously, under the dual effects of policy guidance and market regulation, there will be more companies like Captopril that have not been evaluated or won the bid to optimize their product lines by canceling drug approvals, which is also a manifestation of the transformation and upgrading of the pharmaceutical industry.

02 Production gathers together, low-level and high-repeat varieties are "warned"

At the same time, most of the drug approvals that have been cancelled are not exclusive varieties.

At present, many domestic drugs are over-declared.

Excessive repetition of the drug catalog does have some "persuade" effects in reducing the number of approvals, manufacturers, and zombie approvals for the corresponding varieties.

According to data from the State Food and Drug Administration, there are thousands of approvals for 6 drugs including Analgin, compound sulfamethoxazole, paracetamol, vitamin C, glucose, and metronidazole, which are 1,275, 1,284, and 1,301, respectively.

Obviously, the list of excessive repeated use of drugs reminds relevant pharmaceutical companies to make reasonable evasions in project establishment, research and development, and agency.

03 Reappearance of multinational pharmaceutical companies

It is worth noting that among the 18 pharmaceutical companies that have revoked the approval this time, multinational pharmaceutical companies have once again appeared.

Among them, this time Bristol-Myers Squibb revoked the drug registration approval for 0.

Bristol-Myers Squibb is not the first multinational pharmaceutical company to voluntarily revoke the approval.
In recent years, many multinational pharmaceutical companies have applied to revoke the approval.

According to incomplete statistics, as early as 2018, Novartis, Takeda, and Merck had successively revoked some product regulations of the original products: Novartis revoked zoledronic acid for injection; Takeda revoked alogliptin benzoate tablets; Merck revoked Approval for recombinant follicle stimulating hormone β injection; In 2020, Roche revoked some product regulations of trastuzumab for injection; Pfizer revoked its approval for tigecycline for injection.
.
.
Shantian, Teva, BI and other foreign companies also have several Application for cancellation of product regulations, and it is rare for Bristol-Myers Squibb to revoke 12 drug approvals in one breath.

Although the specific reasons for Squibb’s application for cancellation of the approval document are not yet known, the analysis pointed out that from the past experience of multinational pharmaceutical companies applying for drug delisting, the delisting of original research drugs is often affected by many factors, and the approval period has expired and the product has been changed.
Product regulations, low market demand, and optimized product management may all be reasons for voluntarily revoking approvals.