α-GPC can be adjusted in advance up on to clinical plan

First official position after clinical reevaluation announcement, there was no consultation with the MOHW

Determining the period and method after reviewing the plan

The MFDS briefed on the clinical evaluation of Choline alfoscerate on the 30th.

The MFDS announced its position for the first time in the clinical re-evaluation of 'Choline alfoscerate', a brain function improving agent.

 

The MFDS said there were no procedural issues related to this evaluation, and the duration or number of tasks will be decided after the clinical plan is received.

 

However, it emphasized that approval could be adjusted even before clinical re-evaluation.

 

The drug safety evaluation department, the main department of clinical re-evaluation of Choline alfoscerate, held a briefing for reporters at the headquarters in Osong on the morning of the 30th.

 

The briefing was attended by Kim Jung-yeon, director, and Yoo-bin Lee, Secretary of the Department of Pharmacy Safety Evaluation, and Kim Mi-jung, who conducted internal review of Choline alfoscerate formulations.

 

The MFDS actively explained the suspicion of protests surrounding clinical re-evaluation on the day, but was cautious about specific schedules and methods.

 

When the clinical re-evaluation decision was later than the reimbursement re-evaluation, Kim Jeong-yeon said, “The drug price re-evaluation and drug efficacy re-evaluation were operated separately.” Although communication between agencies was different, the timing of the decision was different because the decision range was different.

 

She added, "When conducting a clinical reevaluation, we do not consult with the MOHW regarding the drug price." The Central Pharmaceutical Affairs Review Committee said, it was not true that there was no vote.

 

"The committee asked whether the clinical re-evaluation of Choline alfoscerate approval was conducted, and all agreed," said Kim.

 

"We plan to open a committee on the validity of the proposal and decide whether to target it." The committee decides when a majority (2/3) or more agree, and the clinical re-evaluation of Choline alfoscerate is 'all agree'.

 

However, the MFDS explained that the future schedule and direction should be reviewed by reviewing clinical plans from companies by December 23.

 

"The number of clinical tasks for each indication and the time period to set the plan must come in and it is difficult to determine whether or not dementia is present even in the first indication," said Lee Yu-bin.

 

"Choline alfoscerate is an old item that has been approved for 95 years, and its efficacy and effectiveness are wide in current standards.

 

If the company prepares a clinical plan with specific indications, it will be possible to adjust the permit even before re-evaluation." "When conducting clinical trials for patients with dementia, it can be done alone or in combination with other drugs, and although there are some standards internally, it is necessary to look at the data submitted by the company," she said.

 

She said that if there is a new overseas basis among domestic clinical reevaluation, it can be used as a reference.

 

The MFDS plans to clarify the special reevaluation target in the future.

 

In this regard, it is an explanation that the details of the reasons for selection have not been detailed in the past, and have not been conducted in connection with the re-evaluation of Choline alfoscerate.

 

"In the future, we will select a special reevaluation target by reviewing it according to standards," said Kim Jeong-yeon.

 

"Choline alfoscerate needs to be validated by the current standards even if there were no problems 25 years ago according to the standards at the time," he said.