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식약처 "메디톡스 '메디톡신주' 품목허가 취소" - 바이오스펙테이터

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식약처 "메디톡스 '메디톡신주' 품목허가 취소"

입력 2020-06-18 07:33 수정 2020-06-18 07:44

바이오스펙테이터 장종원 기자

3개 품목 26일자로 품목허가 취소 결정.."서류조작, 무관용 원칙으로 대응"

메디톡스의 보툴리눔 톡신 제제 '메디톡신주'에 대해 품목허가 취소 결정이 내려졌다.

식품의약품안전처는 18일 메디톡스의 보툴리눔 톡신 제제 '메디톡신주' 3개 품목에 대해서 품목허가를 취소한다고 밝혔다.

품목허가 취소 대상은 메디톡신주, 메디톡신주50단위, 메디톡신주150단위 3개 품목으로 오는 26일자로 품목허가가 취소된다.

앞서 식약처는 지난 4월 17일자로 3개 품목의 잠정 제조·판매·사용을 중지한 뒤 품목허가 취소 등 행정처분 절차를 진행해 왔다.

식약처에 따르면 메디톡스는 메디톡신 생산과정에서 무허가 원액 사용과 서류 조작했으며, 원액 및 역가시험 결과를 허위 기재했으며 조작된 자료로 식약처 국가출하승인을 받아 시중에 의약품을 판매했다.

이에 따라 식약처는 제조·품질관리 서류를 허위로 조작한 메디톡스의 약사법 위반행위에 대해 메디톡신 3개 품목은 허가 취소, 또다른 보툴리눔 톡신 제품인 '이노톡스'는 제조업무정지 3개월에 갈음하는 과징금 1억7460만원을 처분했다. 이와 함께 허가 취소된 메디톡신 3개 품목을 회수·폐기토록 명령했다.

식약처는 이번 품목허가 취소 결정과 관련해 "메디톡스는 2012년부터 2015년까지 지속·반복적으로 원액을 바꿔치기하고 원액 및 제품의 시험성적서 등을 고의로 조작한 것이 검찰 수사를 통해 밝혀졌다"면서 "앞으로 국민의 건강을 위협하고 관리당국을 기만하는 서류 조작행위에 대해 무관용 원칙으로 강력하게 단속·처벌할 방침"이라고 밝혔다.

앞으로 제조·품질관리 서류 조작을 근절하기 위해 의약품 제조·품질 관리기준(GMP) 중 데이터 신뢰성 보증 체계를 집중적으로 강화하는 동시에 국가출하승인 제도 운영을 개선, 강화하겠다고 밝혔다.

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