[Reporter's view] The MFDS shouldn't selectively explain

In a recent series of incidents, the MFDS did not properly explain, causing confusion.

 

It wasn't a big issue, but it's not something to skip.

 

The issue of whether the RNA-based QTP104, which was approved for phase 1 clinical trial on the 20th, was initially marked as "domestic development" on a site where approval status can be checked, but it was changed to "foreign development." A reporter raised a question through an article, and this time it was changed to "domestic development." As a result, there was confusion among reporters.

 

The vaccine could not be clearly processed because it was not distinguished whether it was the first RNA-based or overseas vaccine.

 

As of 4 p.m.

 

on the 22nd, it is marked as "domestic development," so it seems to be a domestic development vaccine, but there is no clear answer from the MFDS.

 

It is the government's long-cherished project to localize the RNA vaccine that Pfizer and Moderna monopolized.

 

As there is also a great interest in the public, it was important to understand the reality of phase 1 clinical approval of QTP104.

 

However, the MFDS has changed its mark from "domestic development" to "foreign development" again, making it difficult to identify the reality.

 

I also asked the MFDS.

 

Even now, the MFDS should quickly answer whether QTP104 is a vaccine developed in Korea.

 

It seems necessary to explain the use and capacity change of the 31st new drug "Leclaza" developed by Yuhan.

 

The MFDS said it was legally changed at the request of the company, but the usage and capacity were changed a day before the benefit confirmation this month.

 

.Moreover, it is necessary to clarify why the dosage and indications have been changed because the diagnosis method is different compared to Leclaza's competitive drug Tagrisso

 

.The MFDS should not just announce on its website the cancellation of the item license of Daewoong's Albis D, but explain it more actively

 

.Previously, the Fair Trade Commission and the Korea Intellectual Property Office detected data manipulation during the patent registration process of this product

 

.The cancellation of item permits is the strongest disposition that the MFDS can make

 

.It should be explained whether the disposition is an extension of the disposition of the Fair Trade Commission and the Korean Intellectual Property Office, or is part of the GMP investigation

 

.Watching this series of events, I suspect that the MFDS is deciding what to explain

 

.It also seems that there is no problem with procedural justification or neglects explanation if it does not become an issue

 

.Even though the method of storing the Pfizer vaccine was changed last time, journalists of daily and economic newspapers raised questions because they did not notify it

 

.Since the MFDS has not explained each and every change in permission, the reporter thought it would not be a big issue

 

.However, As the MFDS' lack of objectiveness continues, it may not have been recognized as a public communication problem.