Consistency Evaluation Approval Reshuffle

Since the country first announced the list of products that have passed the consistency evaluation in December 2017, the deadline for "complete consistency evaluation within 3 years" has passed for many produc.

Promoting the upgrade of the generic drug industry through consistency evaluation has entered the acceptance stage, and the number of approvals is an important indicat.

This means that the shuffling speed of domestic chemical drug approvals is much higher than the speed of new approvals, and the consistency evaluation has a significant effect on the upgrading of the generic drug indust.

Top 50 varieties of approved documents

Ranked by the number of historical approvals, the top 50 varieties of domestic chemical drugs with the largest number of historical approvals had a total of 33,362 approvals during the peak period, and 21,792 approvals remained as of April 202

Since 2016, the industry believes that the biggest driving force for the elimination of chemical drug approvals is the consistency evaluation poli.

No reference preparation "grandfather medicine"

As shown in Table 1, from the perspective of the elimination of the approval documents of the top 50 chemical drugs with the largest number of historical approvals, many of the top-ranked varieties have no reference preparations and cannot start the consistency evaluati.

For these "grandfather drugs" without reference preparations, should a consistency evaluation be initiated? The reason why the industry has this concern is that, on the one hand, most of these approvals were approved before 2007; on the other hand, these products are exempted from conformity evaluation in foreign countri.

Reasons for enterprises to give up re-registration

Among the varieties with the highest number of historical approvals for chemical drugs, in addition to many that did not pass the consistency evaluation, there are many approvals that have not been re-register.

Pre-judgment disappearance approval document next stop

Once the first company is approved for consistency, it is expected that many approval documents will be eliminated in the next st.

Amoxicillin capsules declared the hottest

The number of conformity evaluation declarations can reflect the manufacturer's recognition of the market value of these old approval documents; but it may also be because the API is monopolized, which prevents the company from starting the conformance evaluati.

Over-evaluation of formulary varieties

TOP20 eliminates 2000 approvals

Chronic disease medicines and injections are popular varieties for consistency evaluati.

The remaining approval documents still need to face the pressure of continuous price reduction for centralized procurement in the futu.

As shown in Table 2, in fact, many varieties that have passed the consistency evaluation (including deeming) and formulary belong to the newly approved generic drugs in recent years, such as tadalafil tablets, entecavir tablets, ticagrelor filme.

From the perspective of time, the varieties that can no longer be declared for consistency evaluation include Amlodipine Besylate Tablets, Amoxicillin Capsules, Metformin Hydrochloride Tablets, Rosuvastatin Calcium Tablets, Atorvastatin Calcium Tablets, Metformin Hydrochloride Sustained-Release Tablets tablets, montmorillonite powder, olanzapine tablets and tenofovir disoproxil fumarate table.

Whether to guarantee the approval after the three-year period

In theory, the first application that passes the consistency evaluation will not be accepted for three yea.

According to the policy, "after the first variety has passed the consistency evaluation, the same variety of other drug manufacturers should, in principle, complete the consistency evaluation within 3 years", that is, the consistency evaluation cannot be applied for after the 3-year peri.

In addition, there are still companies that have re-registered with the approval of amoxicillin capsul.

Assuming that the re-registration of a product expires in April 2022, the deadline for consistency evaluation is March 2022, and the product submits an application for consistency evaluation in February 2022, then, even if the consistency evaluation has not been approved, the company's re-registration Can registration be approved? This is a detail that the industry pays more attention .

Thinking questions<<<

Which approvals are worth re-registration?

The consistency evaluation of domestic enterprises investing in generic drugs, in the final analysis, is the market opportunity brought by the shuffling of approval documen.

However, from the perspective of the variety of amoxicillin capsules, the provinces should, in principle, complete the consistency evaluation for the same variety of other drug manufacturers within 3 years after the first variety has passed the consistency evaluati.

The implementation of the "re-registration" policy has not formed uniform implementation rul.

In the policy of encouraging companies to do consistency evaluation, if three or more companies of the same type of drug have passed the consistency evaluation, they will not be allowed to sell products that have not passed the consistency evaluation in medical institutio.

At present, this policy has basically been implement.

On the other hand, judging from official data, there is currently no comprehensive public data on the first company that passed the consistency evaluation and the time when the first company passed the consistency evaluati.

This means that there is no authoritative data on which products cannot start the consistency evaluation after 3 yea.

In addition, for products that have not started conformity evaluation, there are no uniform rules around whether re-registration can be delayed, and the standards for del.

Improving industry concentration by shuffling approval documents is the original intention of formulating the poli.

The delay in the shuffling of approval documents will affect the willingness of enterprises to apply for consistency evaluati.

At present, most of them rely on the self-consciousness of the enterprise, that is, the enterprise voluntarily does not declare and re-regist.

The industry maintains a certain wait-and-see attitude on whether to guarantee the approv.

However, under the background of industrial upgrading, for those varieties that have been declared together, it is very risky to invest in insurance approval documents aga.

For varieties with fewer over-evaluated and declared manufacturers, the risks and opportunities of re-investing in the approval documents coexi.