BA-linked listed drugs are about to be re-evaluated

Will the issue be settled?

A face-to-face briefing on the 22nd

Need to solve aseptic control group drugs

Aseptic formulations will be included in the re-evaluation of the registered drug for BA test from October With the re-evaluation of listed drugs subject to the BA test scheduled to begin in October, attention is being reimbursed to whether some procedural problems will be resolved in advance.

 

The MOHW announced that it would directly conduct BA tests and re-evaluate the price of listed drugs in July 2023 after a three-year grace period.

 

Accordingly, the HIRA will receive data from pharmaceutical companies to prove whether they meet the standard requirements from October to February next year.

 

The question is whether the item will be able to submit related data by the deadline as it has expanded to the aseptic formulation for BA test since October this year.

 

The HIRA plans to consult with the MFDS on necessary measures such as the selection of control drugs for data submission.

 

According to the industry on the 16th, the HIRA will hold a briefing session from 1:30 p.m.

 

on the 22nd at the White Veil located in Seocho-gu, Seoul.

 

It is expected that the number of pharmaceutical companies related to the re-evaluation of the listed drug, which is a face-to-face explanation circuit that takes place for the first time in a long time, will exceed the capacity of the place.

 

The HIRA plans to re-evaluate listed drugs with the aim of applying them in July 2023 as scheduled.

 

Accordingly, pharmaceutical companies are requesting to submit data to prove whether they meet the standard requirements from October to February next year.

 

The core of the data is whether to prove equivalence through BA and others.

 

Most of the requirements for using registered raw materials drugs are expected to be met.

 

To this end, pharmaceutical companies have conducted BA tests by converting consigned manufactured items that have not undergone BA tests into their own production items.

 

The problem is that the drugs will also be subject to the BA test from October, when the data is submitted.

 

The health authorities say these aseptic drugs are subject to re-evaluation of drug prices.

 

After October, the equivalence must be demonstrated through the BA test for aseptic drugs such as injections or the chemical equivalence test that replaces them.

 

The problem is that comparators for tests will not be announced until after October.

 

The pharmaceutical industry believes that it may be difficult to submit data by February next year if the process of selecting a contrast agent is delayed.

 

An official from a pharmaceutical company pointed out, "It is unlikely that companies with many items will be able to manage their schedules," adding, "Aseptic drugs subject to BA tests in October need to extend the deadline for submitting data or hurry to announce control drugs." The MFDS is aware of this.

 

Accordingly, the government plans to apply for and announce the control group drug from time to time, and improve the recognition process.

 

At a meeting with the Korea Special Press Association on the 14th, Kim Ae-ryeon, head of the HIRA drug management office, said, "There is a need for consultation with the MFDS regarding the designation of contrast agents." In March, the HIRA unveiled 3,372 product groups of control drugs and first-time registered products that are excluded from revaluation among 33,618 listed items.

 

As a result, it is expected that items subject to re-evaluation, including aseptic drugs, will be clearly disclosed at the briefing session on the 22nd.