식품의약품안전처가 바이오시밀러에 대한 신속심사 근거 마련과 바이오의약품의 제조방법 변경관리 체계 개선 등을 주요 내용으로 하는 '생물학적제제 등의 품목허가·심사 규정'을 6일 개정·시행한다고 밝혔다.
이번 개정은 올해 시행된 바이오시밀러의 허가기간이 406일에서 295일로 단축됨에 따라 신속심사 대상에 을 바이오시밀러를 추가하는 등 신속허가를 위한 행정지원 근거를 마련하기 위해 추진됐다.
또한, 그간 '변경허가' 절차로만 가능하였던 생물학적제제 등의 제조방법 변경에 대해서는 품질에 미치는 영향이 경미한 경우 등에는 시판 전 보고 또는 사후보고(연차보고)를 허용한다. 바이오의약품의 신속한 변경관리 체계를 마련하기 위해서다. 간접 용기·포장의 변경이나 공정의 명칭 변경, 기재사항의 정정 등이 해당된다.
식약처는 "이번 개정이 바이오의약품의 산업 발전을 지원하는 동시에 허가 체계를 보다 합리적으로 정비한 것"이라며 "앞으로도 행정지원을 통해 제도를 지속적으로 개선해 나가겠다"고 밝혔다.
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