FDA鐕�(y铆ng)椁�(y菐ng)鎴愬垎妯�(bi膩o)绨芥柊瑕�(gu墨)姝ｅ紡瀵�(sh铆)鏂�,鈥滄坊鍔犵硸鈥濆繀闋堣伈鏄�
鐧�(f膩)甯�: 2020.02.28
浠婂勾浼婂锛岀編鍦�(gu贸)椋熷搧钘ュ搧鐩�(ji膩n)鐫ｇ鐞嗗眬锛團DA)鐧�(f膩)甯冧簡銆婇鍝侀鐢ㄩ噺銆佷俊鎭洐鍒楁帓甯冩(bi膩o)绨芥渶绲傛寚鍗椼��,锛屼互骞姪椋熷搧鐢熺敘(ch菐n)寤犵鍚團DA鐨勭嚐(y铆ng)椁�(y菐ng)妯�(bi膩o)绨芥硶瑕�(gu墨),銆傞�欐剰鍛宠憲缇庡湅(gu贸)FDA鐕�(y铆ng)椁�(y菐ng)鎴愬垎妯�(bi膩o)绨芥柊瑕�(gu墨)鐝�(xi脿n)宸叉寮忓(sh铆)鏂姐��
瑭叉渶绲傛寚鍗楄鏄庝簡椋熷搧椋熺敤閲忓強瀵�(sh铆)鏂戒俊鎭洐鍒楁帓甯冩(bi膩o)绨界殑瑕佹眰,銆傛渶绲傛寚鍗楁秹鍙�:
1,銆佸柈娆￠鐢ㄧ殑椋熷搧鍖呰鐨勫畾缇╋紱
2,銆佹寜鎱ｄ緥椋熺敤鐨勯鍝佸弮鑰冩暩(sh霉)閲�,锛岀浉闂�(gu膩n)鍏徃鎳�(y墨ng)鏍规摎(j霉)鎸囧崡纰哄畾椋熺敤閲忥紱
3,銆侀洐鍒楁(bi膩o)绨藉晱椤�,锛屽寘鎷(bi膩o)绨芥牸寮忓晱椤岋紱
4,銆佸叾浠栧晱椤�,锛屽鍙ｉ绯栨(bi膩o)绀恒�侀浂鍞鍝佺殑鍖呰绛�,銆�
鏍规摎(j霉)瑭叉柊瑕�(gu墨),锛岄嚌灏�(du矛)骞村害椋熷搧閵峰敭椤嶇偤涓�鍗冭惉缇庡厓鎴栦互涓婄殑鐢熺敘(ch菐n)寤犲晢锛屽緸2020骞�1鏈�1鏃ラ枊濮�,锛屾(bi膩o)绨藉氨蹇呴爤绗﹀悎FDA娉曡(gu墨),锛涘勾搴﹂姺鍞灏戜簬涓�鍗冭惉缇庡厓鐨勭敓鐢�(ch菐n)寤狅紝鍏跺繀闋堢鍚堟硶瑕�(gu墨)鐨勬棩鏈熷皣鍐嶅欢闀�(zh菐ng)涓�骞�,锛涢嚌灏�(du矛)鍠竴鎴愬垎绯栭,锛屽铚傝湝銆佹绯栨伎,銆佹煇浜涜敁瓒婃鐢�(ch菐n)鍝佺殑鐢熺敘(ch菐n)寤�,锛岀鍚堟硶瑕�(gu墨)鐨勬棩鏈熷欢闀�(zh菐ng)鑷�2021骞�7鏈�1鏃ャ��
FDA鐨勬柊妯�(bi膩o)绨芥硶瑕�(gu墨)涓昏鏄挤(qi谩ng)鍒惰姹備紒妤�(y猫)灏�(du矛)椋熷搧妯�(bi膩o)绨界殑鐕�(y铆ng)椁�(y菐ng)鎴愬垎琛�,锛岄鐢ㄥ垎閲�,锛屾瘡鏃ラ鐢ㄩ噺锛屼互鍙婃洿澶氭柟闈㈢殑鍏�(n猫i)瀹归��(j矛n)琛屾洿鏂�,銆傚叾涓緢閲嶈鐨勪竴榛�(di菐n),锛孎(xi脿n)DA瑾�(r猫n)璀夋(bi膩o)绨介澶栧鍔犱簡灏�(du矛)鈥滄坊鍔犵硸鈥濈殑妯�(bi膩o)绀鸿姹傘�傚湪椋熷搧涓坊鍔犵硸鏄偤浜嗗鍔犻鍝佺敎鍛�,锛屽苟涓旀坊鍔犵硸閫氬父鑸囬鍝佷腑澶╃劧绯栫殑椤炲瀷涓嶅悓,锛孎(xi脿n)DA瑾�(r猫n)鐐猴紝濡傛灉涓�鍊�(g猫)浜烘敐鍏ョ殑鑳介噺鏈�10%浠ヤ笂渚嗚嚜浜庢坊鍔犵硸,锛岄偅涔堜粬寰堥洠灏囨瘡澶╂敐鍏ョ殑鑳介噺鎺у埗鍦ㄥ缓璀板�间互鍏�(n猫i),锛屽挨鍏舵槸鐣�(d膩ng)椋查涓寘鍚緢澶氬寘瑁濋鍝佹檪(sh铆),銆傚洜姝わ紝鏂版(bi膩o)绨芥湁鍔╀簬璁撴秷璨�(f猫i)鑰呬簡瑙ｉ鍝佷腑娣诲姞绯栫殑鍚噺,锛屽皪(du矛)鍚堢悊鏀濆叆鑳介噺鏈夐噸瑕佹剰缇�,銆�
鏍规摎(j霉)鍏叡鍒╃泭绉戝(xu茅)涓績锛圕SPI锛夌殑瑾�(di脿o)鏌ワ紝濡備粖缇庡湅(gu贸)浜烘瘡澶╁钩鍧囨秷鑰楁帀23鑼跺寵椤嶅鐨勭硸,銆傞�欎簺鐢滃懗鍔戦毐钘忓湪涓�鍒囧緸浣犲枬鐨勮尪鍒颁綘鍚冪殑閰稿ザ鍜岃卜鐨勮姳鐢熼啲涓�,銆傚湪椋查涓坊鍔犻亷澶氱殑绯栧彲澧炲姞榻查綊銆佽偉鑳�,銆佸績鑷熺梾鍜岀嚐(y铆ng)椁�(y菐ng)涓嶈壇鐨勯ⅷ(f膿ng)闅�(xi菐n),銆�
FDA灏�(du矛)鏂板鈥滄坊鍔犵硸鈥濈殑妯�(bi膩o)绨借姹傛槸浠�涔堬紵 鏍规摎(j霉)瑭茶(gu墨)鍓�,锛屾瘡浠藉惈鏈�1鍏嬫垨鏇村鈥滄坊鍔犵硸鈥濈殑鐢�(ch菐n)鍝佺殑妯�(bi膩o)绨藉繀闋堝湪鈥滅附绯栭噺鈥濅笅绺��(j矛n)妯�(bi膩o)绀衡�滃寘鍚玿x g娣诲姞绯栤��,锛屽惈鏈夊皯浜�1鍏嬫坊鍔犵硸鐨勭敘(ch菐n)鍝佺殑妯�(bi膩o)绨藉鏋滀粬鍊戜笉鍋氫换浣曠敎鍛冲姂鎴栫硸鑱茬ū锛屽墖鐒￠渶鐢冲牨(b脿o),锛涚浉鍙�,锛岄�欎簺妯�(bi膩o)绨藉彲鑳介渶瑕佸湪鐕�(y铆ng)椁�(y菐ng)鍍�(ji脿)鍊艰〃鐨勫簳閮ㄩ’绀衡�滀笉鏄噸瑕佺殑娣诲姞绯栦締婧愨�濄��
1,銆佽┎瑕�(gu墨)鍓囧皣鈥滄坊鍔犵硸鈥濆畾缇╃偤鍦ㄩ鍝佸姞宸ラ亷绋嬩腑鍔犲叆鐨勭硸锛堟父闆㈢殑鍠硸鍜屼簩绯栵級,銆佺硸婕裤�佽渹铚滃拰婵冪府鏋滆敩姹佷腑瓒呭嚭瑭插ぉ鐒舵灉钄眮鐨勭硸鍒�,锛屼富瑕佸瓨鍦ㄤ簬鍚硸椋叉枡锛堝杌熼２鏂�,銆佹按鏋滈２鏂欍�佸挅鍟″拰鑼�,銆侀亱(y霉n)鍕�(d貌ng)鑳介噺椋叉枡浠ュ強鍚厭绮剧殑椋叉枡锛夊拰闆堕绯栨灉锛堝璋烽鐢滈粸(di菐n),銆佷钩鍒跺搧鐢滈粸(di菐n)銆佺硸鏋�,銆佹灉閱拰绯栨伎锛変腑,銆傛柊瑕�(gu墨)瑕佹眰鍔犲伐閬庣▼涓坊鍔犵殑绯栵紝瑷�(j矛)鍔冩坊鍔犲埌椋熷搧涓殑绯�,锛屼互鍙婃煇浜涜嚜鐒跺瓨鍦ㄧ殑绯栧繀闋堣鍦ㄢ�滅附绯栭噺鈥濅箣澶栧彟澶栧柈鐛�(d煤)鑱叉槑,銆�
2銆丗DA瑕佹眰鍒堕�犲晢淇濈暀鍦ㄥ姞宸ュ墠鍜屽姞宸ラ亷绋嬩腑娣诲姞鐨勭硸鐨勮閷勪互鍙婅垏椋熷搧涓�璧蜂綔鐐哄柈鐛�(d煤)鎴愬垎鍖呰鐨勭硸,锛屽鏋滈�氶亷鐧�(f膩)閰垫垨鐒︾硸鍖栭檷浣庣硸,锛屽埗閫犲晢鍙互淇濆瓨绉戝(xu茅)鏁�(sh霉)鎿�(j霉)鐨勮閷勶紝浠ラ(y脿n)璀夎伈鏄庣殑鏁�(sh霉)閲忔槸姝ｇ⒑鐨�,锛屾垨鑰呰珛(q菒ng)姹傛浛浠ｇ殑鍚堣(gu墨)鏂瑰紡,銆傚埗閫犲晢蹇呴爤璀夋槑鎵�鏈夋暩(sh霉)鎿�(j霉)鐨勬簴(zh菙n)纰烘�с�侳DA瑕佹眰鍦ㄧ敘(ch菐n)鍝侀��(j矛n)鍏ョ編鍦�(gu贸)甯傚牬(ch菐ng)鍚庡皣瑷橀寗淇濆瓨鍏╁勾銆�
鐐轰粈涔團DA瑕佹眰澧炲姞绯栭鑱叉槑,锛�
灏堝瑾�(r猫n)鐐衡�滃湪妯�(bi膩o)绨戒笂澧炲姞绯栫殑妯�(bi膩o)璀�(sh铆)灏囦娇浜哄�戦渿椹氱殑鎰忚瓨(sh铆)鍒颁粬鍊戝悆浜嗗灏戠硸,锛岄�欎篃榧撳嫷(l矛)浼佹キ(y猫)閲嶆柊瑷�(sh猫)瑷�(j矛)鐢�(ch菐n)鍝佺殑閰嶆柟锛屼娇瀹冨�戞洿鍋ュ悍,?锛�?br />
2015骞磋喅椋熸寚鍗楀挩瑭㈠鍝℃渻(hu矛)锛圖GAC锛夌殑鍫�(b脿o)鍛婂缓璀版笡灏戠編鍦�(gu贸)浜虹殑椋查涓坊鍔犵殑绯栵紝鍥�?y脿n)姒堝悶鑿檢鍏ラ噺鑸囧績琛�绠＄柧鐥呴ⅷ(f膿ng)闅�(xi菐n)闄嶄綆涔嬮枔瀛樺湪寰堝挤(qi谩ng)鐨勭浉闂�(gu膩n)鎬�,銆�
椋熷搧鍏徃渚濋潬娣诲姞绯栬澈鍙栦簡澶ч噺鍒╂饯(r霉n),锛岀硸妤�(y猫)鍗�(xi茅)鏈�(hu矛)鍜岄浂鍞埗閫犲晢鍗�(xi茅)鏈�(hu矛)閮藉弽灏�(du矛)鍦ㄦ(bi膩o)绨戒笂妯�(bi膩o)绀烘坊鍔犵硸閫欎竴琛�,銆備絾灏辩洰鍓嶈�岃█,锛屼粬鍊戠殑娓歌澶辨晽浜嗐�侳DA鎻愯鍦ㄦ(bi膩o)绨戒腑澧炴坊鈥滀汉宸ユ坊鍔犵硸鈥濅互渚垮公鍔╂秷璨�(f猫i)鑰呯煡閬撳埌搴曟湁澶氬皯鐨勭硸琚汉鐐哄湴娣诲姞閫�(j矛n)浜嗛鍝�,銆傛鑸夋剰鍛宠憲椋熷搧鍒堕�犲晢闇�瑕佺洝蹇湴灏嬫壘浣庡崱璺噷鐨勭敎鍛冲姂渚嗗彇浠ｅ偝绲�(t菕ng)绯栭,銆�
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