1.
鑽墿鍒嗘瀽鐨勪富瑕佷换鍔★細
1
锛?/p>
鑽搧鐨勮川閲忚瘎浠凤紙缁撴瀯纭瘉銆佽川閲忕爺绌躲�佹爣鍑嗗埗璁級
2
锛?/p>
鑽搧璐ㄩ噺淇濋殰涓庣洃鐫ｏ紙鐢熶骇杩囩▼璐ㄩ噺淇濋殰锛屼笂甯傝嵂鍝佽川閲忕洃鐫ｏ級
3
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涓村簥鐢ㄨ嵂鐩戞祴锛堣瘎浠风敤鑽畨鍏ㄦ�с�佹湁鏁堟�э級
2.
鑽搧璐ㄩ噺鏍囧噯鍖呮嫭鐨勫唴瀹规湁鍝簺
1
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鍝佸悕
2
锛?/p>
鏈夋満鑽墿鐨勭粨鏋勫紡
3
锛?/p>
鍒嗗瓙寮忎笌鍒嗗瓙閲?/p>
4
锛?/p>
鏉ユ簮鎴栧寲瀛﹀悕绉?/p>
5
锛?/p>
鍚噺鎴栨晥浠疯瀹?/p>
6
锛?/p>
澶勬柟
/
鍒舵硶
7
锛?/p>
鎬х姸
8
锛?/p>
閴村埆
9
锛?/p>
妫�鏌?/p>
10
锛?/p>
鍚噺鎴栨晥浠锋祴瀹?/p>
11
锛?/p>
绫诲埆
12
锛?/p>
瑙勬牸
13
锛?/p>
璐棌
14
锛?/p>
鍒跺墏
3.
2015
骞磋嵂鍏歌緝涔嬩互寰�鐨勭増鏈湁鍝簺鐗圭偣锛?/p>
1
锛?/p>
鑽吀鏀惰浇鍝佺澧炲姞锛堝骞呰揪
27.4%
锛?/p>
2
锛?/p>
鑽吀闄勫綍锛堥�氬垯锛?/p>
銆佽緟鏂欑嫭绔嬫垚鍗凤紝鏋勬垚銆婁腑鍥借嵂鍏搞�嬪洓閮ㄧ殑涓昏鍐呭銆?/p>
3
锛?/p>
鑽敤杈呮枡鍝佺鏀惰浇鏁伴噺鏄捐憲澧炲姞锛屽闀跨巼楂樿揪
97%
4
锛?/p>
瀹夊叏鎬ф帶鍒剁殑椤圭洰澶у箙鎻愬崌
浠ュ寲瀛﹁嵂鐗╀负渚嬶細
瀹炵幇瀵瑰凡鐭ユ潅璐ㄥ拰鏈煡鏉傝川鐨勫尯鍒帶鍒讹紝
浼樺寲浜嗘姉鐢熺礌鑱氬悎鐗?/p>
鐨勬祴瀹氭柟娉曪紝鏁翠綋涓婅繘涓�姝ユ彁楂樻湁鍏崇墿璐ㄩ」鐩殑绉戝鎬у拰鍚堢悊鎬?/p>
5
锛?/p>
鏈夋晥鎬ф帶鍒跺緱鍒拌繘涓�姝ュ姞寮?/p>
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鐢熺墿鍒跺搧鈥斺�旇繘涓�姝ユ彁楂樻晥鍔涙祴瀹氭柟娉曠殑瑙勮寖鎬э紝
鍔犲己浣撳娉曟浛浠ｄ綋鍐呮硶杩涜鏁?/p>
鍔涙祴瀹氱爺绌朵笌搴旂敤锛屼繚璇佹柟娉曠殑鍑嗙‘鎬у拰鍙搷浣滄�с�?/p>
4.
ICH
鎸囧鍘熷垯鍒嗕负鍑犱釜绫诲埆锛熷垎鍒槸浠�涔堬紵
4
涓被鍒?/p>
1
锛?/p>
ICH
鏈夊叧鑽搧璐ㄩ噺鐨勬妧鏈姹傦紙
Quality,Q
锛?/p>
11
绉?/p>
2
锛?/p>
ICH
鏈夊叧鑽搧瀹夊叏鎬х殑鎶�鏈姹傦紙
Safety,S
锛?/p>
10
绉?/p>
3
锛?/p>
ICH
鏈夊叧鑽搧鏈夋晥鎬х殑鎶�鏈姹傦紙
Efficacy,E
锛?/p>
16
绉?/p>
4
锛?/p>
ICH
鏈夊叧鑽搧缁煎悎鎶�鏈姹傦紙
Multidisciplinary,M
锛?/p>
8
绉?/p>