<p style="border: 1pt rgb(0, 0, 0); border-image: none; line-height: 2.3; text-indent: 0pt; font-size: 14pt;"><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt; font-weight: bold;">식품의약품안전처 고시 제</span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt; font-weight: bold;">2021-51</span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt; font-weight: bold;">호</span></p> <p style="border: 1pt rgb(0, 0, 0); border-image: none; line-height: 2.3; text-indent: 0pt; font-size: 14pt;"><span style="font-family: 한양신명조,굴림; font-size: 14pt;"> </span></p> <p style="border: 1pt rgb(0, 0, 0); border-image: none; text-align: center; line-height: 2.3; text-indent: 0pt; font-size: 16pt;"><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 16pt; font-weight: bold;">국가출하승인의약품 지정</span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 16pt; font-weight: bold;">, </span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 16pt; font-weight: bold;">승인 절차 및 방법 등에 관한 규정 일부개정고시</span></p> <p style="border: 1pt rgb(0, 0, 0); border-image: none; text-align: right; line-height: 2.3; text-indent: 0pt; font-size: 14pt;"><span style="font-family: 함초롬바탕,굴림; font-size: 14pt;"> </span></p> <p style="border: 1pt rgb(0, 0, 0); border-image: none; line-height: 2.3; text-indent: 0pt; font-size: 15pt;"><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 15pt; font-weight: bold;">1. </span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 15pt; font-weight: bold;">개정이유 및 주요내용</span></p> <p style="border: 1pt rgb(0, 0, 0); border-image: none; line-height: 2.3; text-indent: 0pt; font-size: 14pt;"><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 굴림체; font-size: 14pt;">  </span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">국가출하승인 대상 의약품인 혈장분획제제 중 건조농축사람혈액응고Ⅷ인자 등 </span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">5</span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">개 품목의 시료량을 줄이고</span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">, </span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">사람혈청알부민 등 </span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">16</span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">개 품목의 검정항목 중 면역화학시험을 확인시험으로 변경하거나 삭제하는 등 국가출하승인 제도를 적정하게 운영하려는 것임</span></p> <p style="border: 1pt rgb(0, 0, 0); border-image: none; line-height: 2.3; text-indent: -26pt; font-size: 14pt; margin-left: 26pt;"><span style="font-family: 한양신명조,굴림; font-size: 14pt;"> </span></p> <p style="border: 1pt rgb(0, 0, 0); border-image: none; line-height: 2.3; text-indent: 0pt; font-size: 15pt;"><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 15pt; font-weight: bold;">2. </span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 15pt; font-weight: bold;">참고사항</span></p> <p style="border: 1pt rgb(0, 0, 0); border-image: none; line-height: 2.3; text-indent: -17pt; font-size: 14pt; margin-left: 17pt;"><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">가</span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">. </span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">관계법령 </span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">: </span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">생</span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 굴림체; font-size: 14pt;">    </span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">략</span></p> <p style="border: 1pt rgb(0, 0, 0); border-image: none; line-height: 2.3; text-indent: -121pt; font-size: 14pt; margin-left: 121pt;"><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">나</span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">. </span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">예산조치 </span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">: </span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">별도조치 필요 없음</span></p> <p style="border: 1pt rgb(0, 0, 0); border-image: none; line-height: 2.3; text-indent: -121pt; font-size: 14pt; margin-left: 121pt;"><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">다</span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">. </span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">합</span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 굴림체; font-size: 14pt;">    </span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">의 </span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">: </span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">해당사항 없음</span></p> <p style="border: 1pt rgb(0, 0, 0); border-image: none; line-height: 2.3; text-indent: -98pt; font-size: 14pt; margin-left: 98pt;"><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">라</span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">. </span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">기</span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 굴림체; font-size: 14pt;">    </span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">타 </span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">: (1) </span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">행정예고 </span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">: </span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">의견없음</span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">(2021. 6. 4. </span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">～ </span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">2021. 6. 24.) </span><br> <span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">(2) </span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">규제심사 </span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">: </span><span style="border: 1pt rgb(0, 0, 0); border-image: none; font-family: 한양신명조,굴림; font-size: 14pt;">규제 신설·강화 없음</span></p> <p><strong><br></strong></p> <p><strong><br></strong></p> <p><strong>* 자세한 내용은 첨부파일 참고 </strong></p>
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