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1銆佹棆杞帇鐗囨満鐨勪笂閮ㄦ槸鍘嬬墖鐨勬瀯閫狅細瀹冪殑鏋勬垚涓昏渚挎槸鐢變笂鍐層�佷腑妯°�佷笅鍐蹭笁涓竴閮ㄥ垎榪炴帴鎴愪竴浣撶殑錛屽懆杈?9浠樺啿鍘嬫ā鍏峰寑縐扮殑鎽嗗湪杞洏鐨勮竟鐣屼笂涔熸湁宸﹀彸鍐叉潌鐨勫熬绔祵鍦ㄥ浐瀹氫笉鍔ㄧ殑鏇茬嚎鍥炬粦杞ㄤ笂錛屽綋杞洏鍋氳漿鍔ㄥ仴韜繍鍔ㄧ殑鏃跺�欙紝宸﹀彸鍐插嵆浼撮殢鐫�鏇茬嚎鍥捐建瀵間綔鍗囬檷鏈哄仴韜繍鍔ㄨ�屾姷杈懼帇鐗囩殑鐩湴銆?/span>
2銆佷富瑕佺殑宸ヤ綔榪囩▼鍙互鍒嗘垚浠ヤ笅鐨勪袱姝ワ細鈶村～鍏咃紱鈶靛帇鐗囷紱鈶跺嚭鐗囥�備笁閬撶▼搴忔祦紼嬭繛緇紑灞曪紝濉厖鍜屽帇鐗囨湁璋冩暣鎿嶇旱鏈烘瀯錛屼竴鑸兘闄勫甫琛ㄦ槑錛屽疄闄呮搷浣滅畝鍗曠畝鍗曘�?/span>
3銆佽璁懼閫夌敤鐨勬槸嫻佹爡寮忕殑鎶曟枡鏈烘瀯錛岃兘浣垮師鏉愭枡鍖�縐板湴鍏呮枼鐫�妯″瓟錛岄檷浣庣墖閲嶇殑涓嶄竴鏍楓�?/span>
4銆佺數(shù)鏈鴻鍦ㄦ満搴у唴錛岀敤涓夎鐨甫鎷栨嫿铚楄疆铚楁潌浼犲姩杞洏錛屽茍鍦ㄧ數(shù)鏈鴻醬涓婃満鍣ㄨ澶囨棤鏋佸彉閫熺毊甯︾洏錛屾牴鎹數(shù)鍔ㄦ満鐨勬尓鍔紝鍙互闅忔剰鐨勮皟鏁撮�熺巼錛屽簲鐢ㄨ搗渚嗗彲浠ヤ俊璧栬�屼笖娌掓湁鍣０銆?/span>
5銆佹満搴х殑杈逛笂闈㈤厤鏈夊綺夌錛屽湪鍏朵腑鏈夐鏈恒�佸偍綺夊銆佹護綺夊錛屽綋璁懼鍦ㄥ揩閫熷伐浣滀腑鐨勬椂鍊欙紝浼氶�犳垚椋炵矇涓庣珛妯″線涓嬪潬鐨勭矇鏈姸錛屾牴鎹綺夊槾灝嗗叾娓呮壂錛屼笉瀹規(guī)槗璁╃矘鎺ュ鍒幫紝鍧氭寔涓嶆噲宸ヤ綔涓彲浠ョǔ瀹氫竴鍒囨甯搞�俍P730E杞洏寮忓帇鐗囨満鏈変竴縐嶄笁鍘嬪紡縐瀬杞姩錛岃繛緇嚭鐗囩殑璁懼錛屽皢棰楃矑鏉愭枡闄愬畾鎴愬渾鐗囥�佸嵃瀛楀拰寮傚瀷銆佷笁鑹茬墖鍓傘�傚畠涓昏鐢ㄤ互鍒惰嵂涓氬伐涓氱敓浜х殑鐗囩姸鐢熶駭鍒墮�狅紝涓庢鍚屾椂閫傜敤鍖栧伐鍘傘�侀鍝佺被銆佺數(shù)瀛愬櫒浠剁瓑鍒墮�犱笟浼佷笟銆?/span>
鐗規(guī)�э細
1銆佸鍦哄牭鐩栦負涓嶉攬閽㈡澘鍏蟲帀鏂瑰紡錛屽収閮ㄦ┍鏌滃彴闈㈤�夌敤涓嶉攬閽㈡澘鏉愭枡錛岃兘鍧氭寔涓嶆噲琛ㄩ潰鍏夋辰搴︿笌閬垮厤 浜ゅ弶寮忕幆澧冩薄鏌擄紝鍒囧悎GMP瑙勫畾銆?/span>
2銆侀厤鏈夋湁鏈虹幓鐠冩澘閫忚紿楋紝鍙鎬у帇鐗囨儏鍐碉紝杈逛笂鎺у埗闈㈡澘鑳芥墍鏈夊紑鍚紝渚夸簬鍏ч儴娓呴櫎鍜岀淮鎶や繚鍏匯�?/span>
3銆佸叏閮ㄦ搷綰靛櫒鍜屽疄闄呮搷浣滀歡鍧囧悎鐞嗗竷灞�銆?/span>
4銆侀�夌敤鍙橀寮忓彉閫熸満鍣ㄨ澶囧紑灞曠數(shù)姘旇澶囧彉閫燂紝瀹為檯鎿嶄綔渚挎嵎錛岀炕杞ǔ瀹氾紝瀹夊叏鎬х簿鍑嗐�?/span>
5銆佽鏈夎繃鍘嬩繚鎶ゆ満鍣ㄨ澶囷紝褰撳伐浣滃帇鍔涜礋杞芥椂錛岃兘縐瀬鍏蟲満銆?/span>
6銆佷紶鍔ㄨ緗瘑灝佹�у湪鏈嶅姟鍣ㄤ笅杈規(guī)苯杞︽補綆變腑錛屾槸瀹夊叏鎬у垎紱誨嚭鏉ョ殑鍗曠嫭鏋勪歡錛屼害涓嶅鏄撴湁浜掔浉鐜姹℃煋錛屽張浣夸紶鍔ㄧ郴緇熼儴渚墊鼎鍦ㄦ補姹犱腑錛屾槗鎺掔儹涓旇�愮（鎹熴�?/span>
