Will companies be able to apply for EUA for COVID-19 tx?

It's legally possible, but only when the MFDS announces it

Pfizer

The development of COVID-19 treatments is actively progressing at home and abroad.

 

Pfizer's oral treatment Paxlovid received EUA from the MFDS in December last year and is expected to be used in Korea soon.

 

Currently, pharmaceutical companies that develop COVID-19 treatments are in a position to introduce them quickly in Korea through EUA like Paxlovid.

 

By the way, is EUA possible only with the will of pharmaceutical companies?

 

Companies can apply for the EUA.

 

However, the MFDS must first announce the scope of medical products subject to emergency.

 

The EUA is a system introduced under the "Special Act for Promotion of Development and Emergency Supply of Medical Products Responding to Public Health Crisis" enacted in March last year.

 

The EUA refers to the urgent introduction of drugs that have not been approved for domestic items.

 

Even before this law, it was possible to introduce unlicensed imported items in Korea through special import system.

 

In February last year, it was decided to introduce the Pfizer COVID-19 vaccine through special import.

 

However, special import was only possible if the head of related organizations, such as the head of the KDCA, requested special cases.

 

In other words, as a special import procedure, the developer could not request approval for the item.

 

The newly established EUA system can introduce drugs not only at the request of the heads of related agencies, but also when the MFDS deems it necessary to adequately cope with public health crises.

 

At this time, the MFDS must announce ▲ the scope of medical products subject to EUA, and ▲other matters determined by the Minister of Food and Drug Safety as necessary, such as EUA requirements and approval period, etc.

 

Based on this announcement, pharmaceutical companies can apply for the EUA.

 

The application documents include data that can prove the safety and effectiveness of medical products.

 

Evidence such as▲ Clinical trial results of medical products studied until the date of announcement, ▲ current status of domestic and foreign permits, etc., ▲reason for applying for the EUA, ▲ the instructions for the medical product, ▲ Quality inspection results of overseas manufacturing plants, etc.

 

should be submitted.

 

The MFDS is in a position that at least a clinical second-phase report that can prove its validity should be secured.

 

Under this EUA system, pharmaceutical companies that develop COVID-19 treatments have completed phase 2 clinical trials and quickly introduced products into Korea.

 

However, It does not mean that the EUA system can be used according to the will of pharmaceutical companies.

 

Only when the MFDS announces it first can it be applied to pharmaceutical companies.

 

In the current COVID-19 situation, it is not easy for the MFDS to announce alone because the state oversees the purchase of vaccines and treatments.

 

Therefore, like the existing special import system, it is highly likely that the MFDS will review EUA products by applying for KDCA.

 

Pfizer's Paxlovid is also a case in which the EUA was decided by KDCA application.

 

An official from the MFDS explained, "If EUA is needed, corporate applications can be received, but since COVID-19 tx and vaccines are purchased and managed under state control, it will be difficult to do EUA without KDCA applications." The recent plan that pharmaceutical companies that develop COVID-19 treatments will apply for EUA to the MFDS cannot be considered feasible.

 

This is because the state must purchase the treatment.