鏍规摎(j霉)瑕�(gu墨)瀹氾紝鍑℃槸缇庡湅(gu贸)鏈湡鐢熺敘(ch菐n)鎴栫編鍦�(gu贸)閫�(j矛n)鍙ｉ姺(xi膩o)鍞殑椋熷搧銆佽棩鍝侊紙鍖呮嫭鐛歌棩锛�銆侀啱(y墨)鐧傚櫒姊般€侀鍝佹坊鍔犲姂銆佸寲濡濆搧銆佸嫊(d貌ng)鐗╅鍝佸強钘ュ搧銆侀厭绮惧惈閲忎綆浜�7%鐨勮憽钀勯厭椋叉枡浠ュ強闆诲瓙鐢�(ch菐n)鍝侀兘蹇呴爤缍�(j墨ng)閬�(gu貌)FDA妾㈤(y脿n)璀夋槑瀹夊叏鍚�锛屾柟鍙湪甯傚牬(ch菐ng)涓婇姺(xi膩o)鍞€�
鍥�?y脿n)妾獲浜涚敘(ch菐n)鍝佸湪鎶甸亱(y霉n)缇庡湅(gu贸)鍙ｅ哺鏅�(sh铆)锛岄兘鏈�(hu矛)閫�(j矛n)琛岄€愭壒鐨勬娊鏌�锛屾娊鏌ユǎ鍝佸悎鏍�锛岃┎鎵圭敘(ch菐n)鍝佹墠鍙斁琛岋紝濡傛灉涓嶅悎鏍�锛孎(xi脿n)DA鏈夋瑠(qu谩n)灏�(du矛)鐢熺敘(ch菐n)寤犲閫�(j矛n)琛岃瀵�銆佹湁娆�(qu谩n)灏�(du矛)閬曟硶鑰呮彁鍑鸿捣瑷�锛岄倓鍙互閫�(j矛n)琛屸€滆嚜鍕�(d貌ng)鎵ｇ暀鈥濄€�
FDA娉ㄥ唺(c猫)鍜屾娓�(c猫)锛屽偦鍌诲垎涓嶆竻妤�
FDA瑾�(r猫n)璀夐€氬父鍒嗙偤鍌崇当(t菕ng)鐨凢DA娉ㄥ唺(c猫)銆丗DA妾㈡脯(c猫)鑸嘑DA瑭�(p铆ng)浼�
FDA娉ㄥ唺(c猫)锛氱偤浜嗙⒑淇濆粻鍟嗙敘(ch菐n)鍝佸嚭鍙ｇ編鍦�(gu贸)绗﹀悎鐣�(d膩ng)?sh霉)姘愯厙DA瑕佹眰锛岃姹備紒妤�(y猫)鍋氱殑鑷垜瀹ｅ憡鎿�(d膩n)淇濇祦绋�锛屾敞鍐�(c猫)鎴愬姛浠ュ悗鍙互鍦‵DA瀹樼恫(w菐ng)鏌ヨ(x煤n)娉ㄥ唺(c猫)淇℃伅銆�
FDA妾㈡脯(c猫)锛欶DA妾㈡脯(c猫)鏇村鎸囩殑鏄鍝佹帴瑙告潗鏂欑殑瀹夊叏妾㈡脯(c猫)锛岀敘(ch菐n)鍝佹帴瑙搁(l猫i)鍖呰鐨勬娓�(c猫)锛岄啱(y墨)鐧傜敘(ch菐n)鍝佺殑鐢熺墿鍏煎娓�(c猫)瑭�锛岃嚚搴婂畨鍏ㄦ脯(c猫)瑭︾瓑銆�
椤嶆韩QIANG锛堢磪澶栫窔娓�(c猫)婧剙锛夐嚌灏�(du矛)閲忔脯(c猫)浜洪珨椤嶆韩鍩烘簴(zh菙n)瑷�(sh猫)瑷�(j矛)锛屼娇鐢ㄩ潪甯哥啊(ji菐n)鍠�銆佹柟渚�銆�1绉掑彲婧�(zh菙n)纰烘脯(c猫)婧�锛岀劇(w煤)閻冲皠榛�(di菐n)锛屽厤闄ゅ皪(du矛)鐪肩潧涔嬫經鍦ㄥ偡瀹�锛屼笉闇€鎺ヨЦ浜洪珨鐨啔锛岄伩鍏嶄氦鍙夋劅鏌�锛屼竴閸垫脯(c猫)婧紝鎺掓煡娴佹劅銆傞婧玅IANG宸ヤ綔鍘熺悊:浠讳綍鐗╅珨鍦ㄩ珮浜庣禃灏�(du矛)闆跺害(-273鈩�)浠ヤ笂鏅�(sh铆)閮芥渻(hu矛)鍚戝鐧�(f膩)鍑虹磪澶栫窔,椤嶆韩QIANG閫氶亷(gu貌)鍌虫劅鍣ㄦ帴鏀剁磪澶栫窔锛屽緱鍑烘劅鎳�(y墨ng)婧害鏁�(sh霉)鎿�(j霉)銆�
FDA灏�(du矛)閱�(y墨)鐧傚櫒姊扮殑绠＄悊閫氶亷(gu貌)鍣ㄦ鑸囨斁灏凧IANG搴蜂腑蹇冿紙CDRH锛夐€�(j矛n)琛岀殑锛屼腑蹇冪洠(ji膩n)鐫ｉ啱(y墨)鐧傚櫒姊扮殑鐢熺敘(ch菐n)銆佸寘瑁�銆佺稉(j墨ng)閵�(xi膩o)鍟嗛伒瀹堟硶寰嬩笅閫�(j矛n)琛岀稉(j墨ng)鐕�(y铆ng)娲诲嫊(d貌ng)銆傞啱(y墨)鐧傚櫒姊拌寖鍦嶅緢寤�锛屽皬鍒伴啱(y墨)鐢ㄦ墜濂�锛屽ぇ鑷冲績鑷熻捣鍗氬櫒锛屽潎鍦‵DA鐩�(ji膩n)鐫ｄ箣涓�锛屾牴鎿�(j霉)閱�(y墨)鐧傜敤閫斿拰灏�(du矛)浜洪珨鍙兘鐨勫偡瀹筹紝F(xi脿n)DA灏囬啱(y墨)鐧傚櫒姊板垎鐐衡厾銆佲叀銆佲參椤�(l猫i)锛岃秺楂橀(l猫i)鍒ョ洠(ji膩n)鐫ｈ秺澶�
