[앵커]
YTN reported on the suspicion and controversy over the world’s first stem cell treatment through broadcast on the 20th.
The Ministry of Food and Drug Safety has launched an investigation into the suspicion that unauthorized stem cell freezing, which could shake the safety and effectiveness of pharmaceuticals during the manufacturing process, is being done.
Reporter Kim Dae-gyeom reports.
[기자]
Heartiselgram AMI, a treatment for acute myocardial infarction.
It is the world’s first stem cell therapy product approved in 2011.
According to the permission, there are no freezing and thawing procedures anywhere in the manufacturing process.
By the way, as a result of YTN’s coverage, a situation was found that the pharmaceutical company Phamicel freezes some of the stem cells isolated from the bone marrow.
The reason for this unauthorized freezing seems to be because the sale of HeartiCelgram was linked to the frozen storage of bone marrow for stem cell treatment, that is, the banking business.
[줄기세포 보관 영업 사원 : (냉동 보관한) 사람들은 언제든지 와서 맞으려고 하면 해줘야 돼요. 우리가 그렇게 (환자) 모집을 했고, 회사에서도 그렇게 지시를 했고….]
In response, Famicel’s side claimed that it was’freezing’, but in 2007 the KFDA voted to interpret it as’minimal manipulation’.
However, the Ministry of Food and Drug Safety said that such facts were not confirmed, and said that it could not find any documents presented by Famicel as the basis for the interpretation of votes.
In particular, the Ministry of Food and Drug Safety considers that’freezing’ is a violation of the permission matters, regardless of whether or not’minimal manipulation’ falls under the discretion of doctors.
An official from the Ministry of Food and Drug Safety emphasized that’freezing’ in the manufacturing process of HeartiCelgram is not a problem of pharmaceutical quality control standards, but that it violates the approval requirements that pharmaceutical companies must follow.
In the meantime, it cannot be said that it is security that the investigation will be conducted, but after confirming the facts, he said he would administer it according to regulations.
If, as a result of the KFDA investigation, the suspicion of unauthorized freezing turns out to be true, it is possible to suspend the work of Parmicel or cancel the permission of HeartiCelgram.
[신현호 / 의료 전문 변호사 : (냉동, 해동은) 세포치료제를 제조하는 하나의 과정이에요. 그럼 이건 당연히 첨단바이오 의약품 법에 따라서 제조 허가를 받아야죠.]
Apart from the investigation by the Ministry of Food and Drug Safety, the police also launched an investigation into the suspicion of unauthorized frozen manufacturing.
We received a complaint from Mr. A, who had a legal dispute with Kim Hyun-soo, CEO of Famicel, and completed the investigation of the accuser.
This is YTN Kim Dae-gyeom.
[저작권자(c) YTN & YTN plus 무단전재 및 재배포 금지]
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