CDE publishes these 30 varieties of pharmacy research or more stringent!

On February 20, CDE issued the "Technical Requirements for Pharmaceutical Research of the First Batch of Reference Drugs Not Recommended for Reference" (draft for comments), including sodium chloride injection, glucose injection, calcium carbonate D3 tablets, and vitamin B2 tablets Wait for 30 varieties to be selected.

The first batch of 30 "no reference preparations" drug lists involved 12 injections, 14 oral preparations, 3 eye drops, and 1 gas (oxygen).

01 Does the consistency evaluation still need to be carried out?

Since the start of the consistency evaluation of injections in May 2020, the clinical value of "Sodium Chloride Injection, Glucose Injection, Glucose Sodium Chloride Injection, Water for Injection" and other chemical drugs with clear clinical value but no reference formulations can be determined.

In August last year, CDE once again proposed no consistency evaluation for chemical drugs with clear clinical value.

It is worth noting that chemical injections with a clear clinical value but no reference formulations have been identified without consistency evaluation.

Although there is no need to carry out consistency evaluation, the quality of medicines still needs to be strictly guaranteed.

"No reference preparation does not mean stepping in place.

02 Will there be centralized procurement in the future?

According to the current rules that the three companies can trigger centralized procurement after the evaluation, does the “exemption” of the consistency evaluation mean that a series of chemical generic drugs that cannot be determined as reference preparations, such as basic infusion, will not become the national centralized procurement target?

Taking basic infusion as an example, the current basic infusion and other medicines generally follow the policy of direct online procurement.

The person in charge of a large domestic infusion company previously stated publicly that the basic infusion is a high-risk injection, which is heavy, bulky, and low in price.

Although the industry generally believes that it is not necessary to purchase basic infusions in quantities, and some people in the industry said that the Medical Insurance Bureau has also stated that basic infusions will not be collected, but there is no clear policy and regulations, the industry still has doubts about this.

"When the technical requirements for pharmaceutical research are clarified, perhaps the national procurement will follow.