The aftermath of the COVID-19 Pandemic

Until when is the rapid screening of vaccines and treatments?

Ministry of Food and Drug Safety "Planning future measures in consideration of urgency and necessity"

There is a need to convert COVID-19 vaccines and treatments, which had been designated for rapid screening, to general screening to cope with the COVID-19 pandemic situation.

 

This is because it is argued that screening personnel should not be wasted due to rapid screening of COVID-19 vaccines and treatments in a situation where the world is concerned about COVID-19.

 

In addition, there are voices that COVID-19 vaccines and treatments should be excluded from the rapid screening in order to focus on the Global Innovation Product Rapid Review Support System (GIFT) prepared by the Ministry of Food and Drug Safety last year.

 

In this regard, an official from the Ministry of Food and Drug Safety said, "The Ministry of Food and Drug Safety is keeping an eye on the COVID-19 pandemic discussion.

 

As it has been taken based on laws to cope with the COVID-19 public health crisis, we will take measures related to the rapid screening process for COVID-19 vaccines and treatments.

 

Since August 31, 2020, the Ministry of Food and Drug Safety has established a rapid screening department and is conducting rapid screening only for innovative products such as life-threatening diseases or treatments for rare and incurable diseases and drugs that respond to public health crises.

 

From September 2020 to July 2022, 23 items were designated for rapid examination of medicines, and 17 items were designated and subject to rapid approval review.

 

According to the items that have been approved, COVID-19 vaccines accounted for the largest number of items with 10, followed by five chemicals, one biopharmaceutical, and one biopharmaceutical.

 

The rapid screening period aims to shorten the general screening period to 75% of the general screening period, and the number of working days required for the rapid screening of the COVID-19 vaccine was short, averaging 26 days.

 

This is because the screening period was shortened by using preliminary reviews in consideration of urgency, and 5 out of 10 COVID-19 vaccines that were approved were pre-reviewed and frequently reviewed in areas such as clinical, non-clinical, and quality.

 

However, while the workload has increased, some say that the structure of drug screening personnel's work should be reorganized due to the rapid screening system of COVID-19 vaccines and treatments in order to properly utilize the GIFT system in the future.

 

An official from the pharmaceutical industry said, "The seriousness of COVID-19 has decreased to the extent that even the obligation to wear indoor masks is lifted," adding, "The Ministry of Food and Drug Safety should also consider ending the rapid screening system for COVID-19 vaccines and treatments." Some say that all permits and screening personnel have been put into a rapid screening of COVID-19 vaccines and treatments, and other tasks have been pushed back by nearly a year, he said.

 

"To solve the problem, we need to think about completing the system that was applied to a crisis." The United States recently declared that it would end the COVID-19 public health emergency from May to November.

 

Subsequently, there is an opinion that Korea will be able to completely lift its obligation to wear a mask in May.