涓浗鍜屽嵃搴﹁繎鏈熸病鏈夎鍒掑姞鍏?/p>
ICH
鍜?/p>
PICS
(2016-09-19 20:59:04)
涓浗鍜屽嵃搴﹁繎鏈熸病鏈夎鍒掑姞鍏?/p>
ICH
鍜?/p>
PICS
鏍规嵁缇庡浗琛屼笟濯掍綋
Regulatory Focus
锛?/p>
RF
锛夋姤閬擄紝涓や釜鏈�澶х殑鍥介檯鑽搧鐩戠缁勭粐
鈥?/p>
鍥介檯
鍖昏嵂鍝佺ń鏌ュ崗绾︾粍缁囷紙
PIC/S
锛夊拰浜虹敤鑽搧娉ㄥ唽鎶�鏈姹傚浗闄呭崗璋冪悊浜嬩細锛?/p>
ICH
锛夎〃绀轰腑鍥?/p>
鍜屽嵃搴﹀湪杩戞湡娌℃湁浠讳綍璁″垝鍔犲叆浠讳綍涓�涓粍缁囥�?/p>
PIC/S
涓诲腑
Paul Hargreaves
鍦?/p>
9
鏈?/p>
12
鏃ュ湪缇庡浗鍗庣洓椤跨壒鍖轰妇琛岀殑
PDA/FDA
骞翠細涓婅〃绀猴紝
涓浗鏇捐〃杈句簡澶氬勾鏉ュ鍔犲叆
PIC/S
鐨勫叴瓒ｏ紝
PIC/S
宸茬粡浼氳浜嗕腑鍥藉浗瀹堕鍝佽嵂鍝佺洃鐫ｇ鐞嗘�?/p>
灞�锛?/p>
CFDA
锛夌殑鐩稿叧浜哄憳锛屼絾鈥滅敱浜庤鏀胯绔嬫柟寮忥紝杩欏浜庝腑鍥戒笉鏄竴涓畝鍗曠殑杩囩▼銆傗�濅粬
琛ㄧず锛?/p>
鈥滀腑鍥藉湪涓嶅悓鐨勭渷甯傛湁涓嶅悓鐨勬鏌ラ儴闂ㄢ�濓紝
灏界杩欐牱涓浗鍔犲叆
PIC/S
涔熸槸鍙兘鐨?/p>
锛堝洜
涓轰笌寰峰浗鐨勬儏鍐垫湁浜涚被浼硷紝铏界劧寰峰浗鐨勮鏀胯缃樉鐒惰灏忓緢澶氾級锛?/p>
鏁翠釜涓浗瑕佽揪鎴愬崗璁紝鑰?/p>
涓嶆槸浠呪�滄寫閫夊拰缁勫悎鈥濇煇浜涘湴鍖恒�備笌涓浗鐨勫璇濅粛鍦ㄧ户缁�?/p>
Hargreaves
琛ㄧず锛屸�滄暣涓浗瀹?/p>
鍏ㄩ儴鍔犲叆鎴栬�呭叏閮戒笉鍔犲叆鈥濓紝骞惰ˉ鍏呰〃绀猴紝
CFDA
鐢氳嚦涓嶈兘鑷繁鍐冲畾鏄惁鐢宠鍔犲叆锛屽洜涓鸿繖
鏍风殑鍐崇瓥蹇呴』鏉ヨ嚜浜庝腑鍥界殑浠庢斂鑰呫�傝繕鏈夊叧浜庝腑鍥藉彴鍖楀拰棣欐腐鐨?/p>
PIC/S
浼氬憳闂锛屼互鍙婂叾
瀹冨叧浜庤繖涓や釜鍦版柟鏄惁褰掑叆涓浗浣滀负涓�涓暣浣撶殑鏀挎不鍒嗘銆?/p>
Hargreaves
鎸囧嚭锛?/p>
鍗板害鐨勬儏鍐典篃
鈥滈潪甯稿洶闅锯�?/p>
锛?/p>
寰堝鍗板害鍒惰嵂浼佷笟
鈥滈潪甯稿弽瀵瑰姞鍏?/p>
PIC/S
鈥?/p>
锛?/p>
鍥犱负澶槀璐碉紝鑰屼笖鍗板害灏嗕笉寰椾笉鏄捐憲鎻愰珮鏍囧噯浠ユ弧瓒?/p>
PIC/S
鐨勮姹傦紙灏界鍗板害鍟嗗姟閮ㄥ凡缁?/p>
琛ㄨ揪浜嗗鍔犲叆
PIC/S
鐨勫叴瓒ｏ級銆備粬杩樿В閲婃寚鍑猴紝涓�浜涗汉琛ㄧず濡傛灉鍗板害瀵瑰埗鑽敓浜ч噰鐢ㄨ嵂鍝?/p>
鐢熶骇璐ㄩ噺绠＄悊瑙勮寖锛?/p>
GMP
锛夋爣鍑嗭紝鍗板害鎮ｈ�呭皢涓嶈兘璐熸媴寰楄捣鎵�闇�鑽搧銆?/p>
缇庡浗
FDA
鎴樼暐璁″垝鍔炲叕瀹や富浠诲拰
FDA
鐨?/p>
ICH
棰嗗浜?/p>
Theresa Mullin
琛ㄧず锛屾湁鍏充腑鍥藉姞鍏?/p>
ICH
濂圭湅鍒颁簡绫讳技鐨勯棶棰橈紝浣嗘槸鈥滃嵃搴︽病鏈夊弬鍔犳垨鍑哄腑杩?/p>
ICH
浼氳銆傛垜浠病鏈夌湅鍒板嵃搴﹀
鍔犲叆
ICH
琛ㄧ幇鍑轰换浣曠壒鍒殑鍏磋叮銆傗�?/p>