<div class="bv_cont" style="margin: 0px; padding: 15px 20px; border: none; font-size: 15px; line-height: 1.5em; color: rgb(102, 102, 102); font-family: 'Nanum Gothic', 나눔고딕, NanumGothic, '맑은 고딕', 'Malgun Gothic', 돋움, Dotum, sans-serif; background-color: rgb(255, 255, 255);"> <p class="0" style="margin-right: 0px; margin-left: 52px; padding: 0px; border: none; text-indent: -39pt; text-align: center; word-break: keep-all;"><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-weight: bold; font-size: 10pt;">대한민국약전 일부개정고시</span></p><br> <p class="1" style="margin-right: 0px; margin-left: 0px; padding: 0px; border: none;"><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-family: '맑은 고딕'; font-size: 10pt;">1. </span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">개정이유</span></p><br> <p class="2" style="margin-right: 0px; margin-left: 0px; padding: 0px; border: none;"><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;"></span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; letter-spacing: 0pt; font-size: 10pt;">「</span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">대한민국약전</span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; letter-spacing: 0pt; font-size: 10pt;">」</span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">기준</span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-family: '맑은 고딕'; font-size: 10pt;">·</span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">규격을 국제조화하여 의약품의 적정한 품질관리를 합리적으로 지원하고</span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-family: '맑은 고딕'; font-size: 10pt;">, </span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">의약품 등의 개발 및 제약업계의 수요사항 등을 반영한 일부 일반정보를 최신 과학 수준에 맞게 신설함으로써 우수한 품질의 의약품이 유통될 수 있도록 함</span></p><br> <p class="1" style="margin-right: 0px; margin-left: 0px; padding: 0px; border: none;"><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-family: '맑은 고딕'; font-size: 10pt;">2. </span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">주요내용</span></p><br> <p class="0" style="margin-right: 0px; margin-left: 41px; padding: 0px; border: none; text-indent: -30.8pt;"><span style="margin: 0px; padding: 0px; border: none; font-size: 10pt; font-family: '맑은 고딕';"></span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">가</span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-size: 10pt; font-family: '맑은 고딕';">. </span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">시험법 정확도 개선 및 현대화</span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-size: 10pt; font-family: '맑은 고딕';">(</span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">안 별표 </span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-size: 10pt; font-family: '맑은 고딕';">3, 4)</span></p><br> <p class="0" style="margin-right: 0px; margin-left: 41px; padding: 0px; border: none; text-indent: -31pt;"><span style="margin: 0px; padding: 0px; border: none; font-size: 10pt; font-family: '맑은 고딕';"></span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">나</span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-size: 10pt; font-family: '맑은 고딕';">. ‘</span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">알킬설폰산에스테르류 분석법</span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-size: 10pt; font-family: '맑은 고딕';">’ </span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">및 </span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-size: 10pt; font-family: '맑은 고딕';">‘</span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">재조합 </span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-size: 10pt; font-family: '맑은 고딕';">C </span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">인자를 이용한 엔도톡신 시험법</span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-size: 10pt; font-family: '맑은 고딕';">’ </span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">신설</span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-size: 10pt; font-family: '맑은 고딕';">(</span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">안 별표 </span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-size: 10pt; font-family: '맑은 고딕';">6)</span></p><br> <p class="1" style="margin-right: 0px; margin-left: 0px; padding: 0px; border: none;"><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-family: '맑은 고딕'; font-size: 10pt;">3. </span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">기타 참고사항</span></p><br> <p class="0" style="margin-right: 0px; margin-left: 0px; padding: 0px; border: none;"><span style="margin: 0px; padding: 0px; border: none; font-size: 10pt; font-family: '맑은 고딕';"></span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">가</span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-size: 10pt; font-family: '맑은 고딕';">. </span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">관계법령</span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-size: 10pt; font-family: '맑은 고딕';">: </span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">약사법</span></p><br> <p class="0" style="margin-right: 0px; margin-left: 48px; padding: 0px; border: none; text-indent: -36pt;"><span style="margin: 0px; padding: 0px; border: none; font-size: 10pt; font-family: '맑은 고딕';"></span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">나</span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-size: 10pt; font-family: '맑은 고딕';">. </span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">예산조치</span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-size: 10pt; font-family: '맑은 고딕';">: </span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">별도조치 필요 없음</span></p><br> <p class="0" style="margin-right: 0px; margin-left: 0px; padding: 0px; border: none;"><span style="margin: 0px; padding: 0px; border: none; font-size: 10pt; font-family: '맑은 고딕';"></span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">다</span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-size: 10pt; font-family: '맑은 고딕';">. </span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">합 의</span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-size: 10pt; font-family: '맑은 고딕';">: </span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">해당사항 없음</span></p><br> <p class="0" style="margin-right: 0px; margin-left: 0px; padding: 0px; border: none;"><span style="margin: 0px; padding: 0px; border: none; font-weight: bold; font-size: 10pt; font-family: '맑은 고딕';"></span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">라</span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-size: 10pt; font-family: '맑은 고딕';">. </span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">기 타</span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-size: 10pt; font-family: '맑은 고딕';">:</span></p><br> <p class="0" style="margin-right: 0px; margin-left: 0px; padding: 0px; border: none;"><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-size: 10pt; font-family: '맑은 고딕';">(1) </span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">행정예고</span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-size: 10pt; font-family: '맑은 고딕';">(‘23.3.20</span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; letter-spacing: 0pt; font-size: 10pt;">∼</span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-size: 10pt; font-family: '맑은 고딕';">‘23.5.19) </span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">결과 특기사항 없음</span></p><br> <p class="0" style="margin-right: 0px; margin-left: 0px; padding: 0px; border: none;"><span style="margin: 0px; padding: 0px; border: none; font-size: 10pt; font-family: '맑은 고딕';"></span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-size: 10pt; font-family: '맑은 고딕';">(2) </span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">규제심사</span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-size: 10pt; font-family: '맑은 고딕';">: </span><span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">신설</span>·<span style="margin: 0px; padding: 0px; border: none; font-family: '맑은 고딕'; font-size: 10pt;">강화 규제 없음</span></p></div> <div class="bv_file_box" style="margin: 40px 0px -1px; padding: 0px; border-top: 1px solid rgb(109, 109, 109); border-right: none; border-bottom: none; border-left: none; border-image: initial; position: relative; color: rgb(102, 102, 102); font-family: 'Nanum Gothic', 나눔고딕, NanumGothic, '맑은 고딕', 'Malgun Gothic', 돋움, Dotum, sans-serif; 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