A batch of drugs no longer sold by hospitals (with list attached)

Release date:

2020-07-20

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Recently, the Shaanxi Provincial Pharmaceutical and Medical Device Centralized Procurement Platform released the "Announcement (No. 2) on Varieties Involved in the Expansion of the Pilot Program for National Organization of Centralized Drug Procurement and Use."

The announcement indicates that 7 drugs have passed the review and meet the requirements for online listing, while 24 drugs have been disqualified from being listed due to having more than three competing products evaluated. The specific list is as follows:

The "Shaanxi Province Implementation Plan for Expanding the Regional Scope of National Pilot Programs on Centralized Drug Procurement and Use" explicitly states that, for the 25 generic-name drugs included in the expanded pilot program, if three or more manufacturing companies have passed the consistency evaluation for the same drug product, centralized procurement will no longer select products that have not yet achieved such evaluation—provided that supply can be reliably ensured.

Previously, on November 26, 2019, the Shaanxi Provincial Medical Equipment Centralized Procurement Website issued the "Notice on Effectively Implementing the Expansion of the Regional Scope for the National Pilot Program of Centralized Drug Procurement and Use." The notice stated that if three or more products with the same generic name, dosage form, and specification have already been listed and passed the consistency evaluation, the listing qualifications of products that have not yet undergone this evaluation will be revoked. As a result, 19 drugs were removed from the list. Adding these to the 24 drugs now announced, Shaanxi has collectively disqualified a total of 43 drugs from being listed, effectively cutting them off from the hospital market.

A batch of drugs has been removed from the online platform.

According to the "Opinions on Conducting Evaluations of Generic Drug Quality and Therapeutic Equivalence" (Guobanfa [2016] No. 8), issued by the General Office of the State Council on March 5, 2016, it is explicitly required that once three or more manufacturers have passed the consistency evaluation for a particular drug product, drugs that have not undergone such evaluation should no longer be selected in centralized procurement processes and other related activities.

This means that once three pharmaceutical companies have completed the consistency evaluation for this product, those products that haven’t yet passed the evaluation will risk losing their hospital market.

According to the requirements of the National Medical Products Administration, generic drugs—including those containing essential medicines—that were approved for market prior to the implementation of the new registration classification for chemical drugs must, in principle, complete consistency evaluation within three years after the first product has passed such evaluation.

As more and more products successfully pass the consistency evaluation, the three-year deadline following the first approval has become both a source of pressure—and a powerful driving force—for many pharmaceutical companies to keep pushing forward. Otherwise, they risk losing not only their presence in the hospital market, but also potentially even their drug registration approvals altogether.

With the intensive release of policies and documents related to generic drug consistency evaluation, coupled with the advancement of national volume-based procurement, many pharmaceutical companies have already realized that achieving generic drug consistency is an inevitable trend—so much so that they not only need to act, but also should do it promptly.

Otherwise, the product will quickly lose its competitiveness in the market.

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