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瀹為獙瀹よ祫璁綉

CFDA鏀瑰悕鈥滃尰鐤椾骇鍝佺洃绠″眬鈥漀MPA 鏂板鏁板瓧鍖荤枟浜у搧瀹¤瘎鏍囧噯

瀹為獙瀹よ祫璁綉鏃堕棿:2018-09-05 鐐瑰嚮: 娆?/span> 鐧惧害鎼滅储

銆愬璇汇€?/strong>鍥藉鑽洃灞€鑻辨枃绠€绉板畾涓衡€淣MPA鈥濓紝鍏朵腑鈥渕edical products鈥濈殑琛ㄨ堪寮曞彂瀵硅嵂鐩戝眬灏嗘潵瀹¤瘎鍐呭鐨勭寽娴嬨€傛垜鍥芥暟瀛楀尰鐤椾骇鍝佺殑瀹¤瘎鏀跨瓥涓庢爣鍑嗙洰鍓嶈繕涓嶆槑纭紝浣嗗仴搴风偣鏄ㄦ棩鐙鑾锋倝鑽洃灞€鍖荤枟鍣ㄦ瀹¤瘎涓績涓撳瀵规绫讳骇鍝佺殑瀹¤瘎鎬濊矾锛屽垵姝ヨ€冭檻灏嗕綔涓哄尰鐤楀櫒姊版姤鎵圭殑鍖荤枟AI杞欢鍖哄垎涓轰腑浣庨闄┿€侀珮椋庨櫓涓や釜瀹¤瘎......
TAG鏍囩锛?CFDA 鏁板瓧鍖荤枟 NMPA 鍖荤枟浜у搧鐩戠灞€ 浜у搧瀹¤瘎

29鏃ヤ笅鍗堬紝鍘熷浗瀹堕鍝佽嵂鍝佺洃鐫g鐞嗘€诲眬缃戠珯鍙戝竷鐨勬秷鎭樉绀猴紝鑽搧娉ㄥ唽鎶ョ洏杞欢涓墍娑夊強“CFDA”鑻辨枃绠€绉板彉鏇翠负“NMPA”銆?                                                            

 

瀵艰锛氬浗瀹惰嵂鐩戝眬鑻辨枃绠€绉板畾涓?ldquo;NMPA”锛屽叾涓?ldquo;medical products”鐨勮〃杩板紩鍙戝鑽洃灞€灏嗘潵瀹¤瘎鍐呭鐨勭寽娴嬨€傛垜鍥芥暟瀛楀尰鐤椾骇鍝佺殑瀹¤瘎鏀跨瓥涓庢爣鍑嗙洰鍓嶈繕涓嶆槑纭紝浣嗗仴搴风偣鏄ㄦ棩鐙鑾锋倝鑽洃灞€鍖荤枟鍣ㄦ瀹¤瘎涓績涓撳瀵规绫讳骇鍝佺殑瀹¤瘎鎬濊矾锛屽垵姝ヨ€冭檻灏嗕綔涓哄尰鐤楀櫒姊版姤鎵圭殑鍖荤枟AI杞欢鍖哄垎涓轰腑浣庨闄┿€侀珮椋庨櫓涓や釜瀹¤瘎閫氶亾銆傚悓鏃惰瀹氾紝绠楁硶椹卞姩鍨嬭蒋浠舵洿鏂般€佹暟鎹┍鍔ㄥ瀷杞欢鏇存柊瀵艰嚧绠楁硶鎬ц兘璇勪及缁撴灉鍙戠敓鏄捐憲鎬ф敼鍙樼殑锛岄兘灞炰簬閲嶅ぇ杞欢鏇存柊锛岄渶瑕侀噸鏂版姤鎵广€?/span>

CFDA鏀瑰悕鈥滃尰鐤椾骇鍝佺洃绠″眬鈥漀MPA 鏂板鏁板瓧鍖荤枟浜у搧瀹¤瘎鏍囧噯

29鏃ヤ笅鍗堬紝鍘熷浗瀹堕鍝佽嵂鍝佺洃鐫g鐞嗘€诲眬缃戠珯鍙戝竷鐨勬秷鎭樉绀猴紝鑽搧娉ㄥ唽鎶ョ洏杞欢涓墍娑夊強“CFDA”鑻辨枃绠€绉板彉鏇翠负“NMPA”锛屽叾鍏ㄧО涓嶅嚭鎰忓鐨勮瘽渚挎槸“National Medical Products Administration”锛屽嵆鐜板浠婄殑鍥藉鑽搧鐩戠潱绠$悊灞€銆?/p>

鐢?ldquo;drug”鍒?ldquo;medical products”锛屽叾鎵€鎸囩О鐨勫唴瀹规洿鍔犱笓娉ㄤ簬鍖荤枟浜у搧銆?/p>

涓€浣嶆帴杩戝浗瀹惰嵂鐩戝眬鐨勪笓瀹跺垎鏋愯锛屾柊鐨勮〃杩版洿绗﹀悎瀹為檯锛屼粬璁や负缁忓鏍哥鍚堝尰鐤楀櫒姊板畾涔夌殑锛屽寘鎷簰鑱旂綉鍜孉I绛夋暟瀛楀尰鐤椾骇鍝侊紝閮藉簲璇ユ寜鐓у尰鐤楀櫒姊扮鐞嗗苟杩涜澶囨鎴栨敞鍐岋紝杩欑被浜у搧涔熶竴鐩撮兘鏄寜鐓с€婂尰鐤楀櫒姊扮洃鐫g鐞嗘潯渚嬨€嬪紑灞曞伐浣滅殑銆?/p>

CFDA鏀瑰悕鈥滃尰鐤椾骇鍝佺洃绠″眬鈥漀MPA 鏂板鏁板瓧鍖荤枟浜у搧瀹¤瘎鏍囧噯

鍘熼鑽洃灞€缃戠珯娑堟伅鏄剧ずCFDA绠€绉板彉鏇翠负NMPA

鎴戝浗鏁板瓧鍖荤枟浜у搧瀹¤瘎鏍囧噯寰呯粺涓€

Medical products鐨勮〃杩板紩鍙戜簡瀵硅嵂鐩戝眬鐩戠鍐呭瓒呭嚭鑽搧鍜屽尰鐤楀櫒姊扮殑鐚滄祴锛岄殢鐫€浜掕仈缃戙€丄I榛戠鎶€鐨勫彂灞曪紝鍖荤枟浜у搧涓嶆柇鎵╁锛岃嵂鐩戝眬鎵€鐩戠鐨勮嵂姊版槸鍚︿細娑电洊灞傚嚭涓嶇┓鐨勬暟瀛楀尰鐤椾骇鍝侊紵

“涓哄悗缁亴鑳芥墿灞曠暀鍑轰簡绌洪棿銆?rdquo;涓浗鑽搧鐩戠潱绠$悊鐮旂┒浼氫笓瀹跺鍛樸€佸浗瀹惰鏀垮闄㈠壇鏁欐巿鑳¢寤夊姝ゆ鑽洃灞€鏇村悕琛ㄧず銆傝嚦浜庤兘鎵╁睍澶氬皯锛?ldquo;杩樺緱鐪嬩笁瀹氭柟妗?rdquo;銆?/p>

杩戞棩鍏竷鐨勫浗瀹惰嵂鐩戝眬涓夊畾鏂规鏄庣‘锛屽浗瀹惰嵂鐩戝眬鐩戠瀵硅薄涓鸿嵂鍝併€佸尰鐤楀櫒姊板拰鍖栧鍝佷笁绫伙紝鍖呮嫭瀵硅繖涓夌被浜у搧鐨勫畨鍏ㄧ洃鐫g鐞嗐€佹爣鍑嗙鐞嗐€佹敞鍐岀鐞嗐€佽川閲忕鐞嗐€侀闄╃鐞嗐€傝嚧浼楃鎶€甯傚満閮ㄧ粡鐞嗘潹杈惧憡璇夊仴搴风偣锛岀洰鍓嶅鍖荤敤杞欢銆佺Щ鍔ㄥ尰鐤楀櫒姊扮瓑涔熼兘鏈変簡娉ㄥ唽鎶€鏈鏌ユ寚瀵煎師鍒欍€?/p>

鏍规嵁8鏈?鏃ヨ捣鐢熸晥鐨勩€婂尰鐤楀櫒姊板垎绫荤洰褰曘€嬶紙浠ヤ笅绠€绉般€婄洰褰曘€嬶級锛屾妸鍖荤敤杞欢鎸変簩绫汇€佷笁绫诲尰鐤楀櫒姊拌缃鎵归€氶亾銆?/p>

銆婄洰褰曘€嬫寚鍑猴紝鑻ヨ瘖鏂蒋浠堕€氳繃鍏剁畻娉曪紝鎻愪緵璇婃柇寤鸿锛屼粎鍏锋湁杈呭姪璇婃柇鍔熻兘锛屼笉鐩存帴缁欏嚭璇婃柇缁撹锛屾湰瀛愮洰褰曚腑鐩稿叧浜у搧鎸夌収绗簩绫诲尰鐤楁鍣ㄧ鐞嗐€傝嫢璇婃柇杞欢閫氳繃鍏剁畻娉曞鐥呭彉閮ㄤ綅杩涜鑷姩璇嗗埆锛屽苟鎻愪緵鏄庣‘鐨勮瘖鏂彁绀猴紝鍒欏叾椋庨櫓绾у埆鐩稿杈冮珮锛屾湰瀛愮洰褰曚腑鐩稿叧浜у搧鎸夌収绗笁绫诲尰鐤楀櫒姊扮鐞嗐€傛墍浠ワ紝鐩墠鎴戜滑鎵€鐪嬪埌鐨凙I浜у搧锛屽ぇ澶氬簲灞炰簬绗笁绫诲尰鐤楀櫒姊般€?/p>

鑷翠紬绉戞妧妫€娴嬩簨涓氶儴鎬荤洃鍙插浗榻愬憡璇夊仴搴风偣锛屼粬璁や负鑽洃灞€鍚嶇О鐨勫彉鍖栧姞寮轰簡鍖荤枟鍣ㄦ鐨勫湴浣嶏紝涓€浜涘睘浜庡尰鐤楀櫒姊扮殑鏁板瓧鍖荤枟浜у搧涓€鐩村浜庤嵂鐩戝眬鐩戠涓紝浣嗛渶瑕佸垎娓呮槸鍚﹀睘浜庡尰鐤楀櫒姊般€?/p>

鍙插浗榻愯〃绀猴紝鐩墠涓浗杩樻湭鏈変竴娆炬槑纭互AI鍔熻兘涓轰富鐨勪骇鍝佺敵鎶ャ€備腑鍥藉尰鐤楀櫒姊拌涓氬崗浼氭櫤鎱у尰鐤楀垎浼氱涔﹂暱绠$嚂鍛婅瘔鍋ュ悍鐐癸紝鐢变簬鐩墠AI浜у搧鐩稿叧鐨勬斂绛栧拰鏍囧噯杩樹笉鏄庣‘锛屼紒涓氫篃寰堣糠鑼€?/p>

瀵规暟瀛楀尰鐤椾骇鍝佺殑瀹¤瘎锛屾潹杈捐〃绀猴紝鍥藉宸茬粡闄嗙画鍙戝竷瀹炴柦浜嗚蒋浠躲€佺Щ鍔ㄥ尰鐤楀櫒姊扮殑娉ㄥ唽鎶€鏈寚瀵煎師鍒欙紝涓€浜涗笟鍐呬汉澹〃绀猴紝浠庡璇勮搴﹀叾瀹炲皻鏈畬鍏ㄤ弗鏍煎疄鏂斤紝鍥犻儴鍒嗘寚瀵煎師鍒欑殑棰佸竷鏃堕棿杩樿緝鐭紝鍏跺疄鏂芥椂闂村皻鐭紝杩樺瓨鍦ㄤ竴浜涗笉鏄庣‘鐨勯棶棰樸€備絾涓€浜涗笉鎻愪緵鍖荤枟鍔熻兘锛屼綔涓虹函绮硅繛鎺ユ偅鑰呬笌鍖婚櫌銆佸尰鐢熺殑骞冲彴鍨嬩簰鑱旂綉浜у搧锛屼笉鑳界畻浣滃尰鐤楀櫒姊般€?/p>

鐩墠锛屼腑鍥芥湁閮ㄥ垎浼佷笟宸茬粡鐜囧厛鐢宠浜嗕簩绫昏瘉銆備絾濡侫irdoc銆佷緷鍥惧尰鐤椼€佹帹鎯崇鎶€绛夌敵鎶ヤ笁绫诲櫒姊扮殑浜у搧閮藉皻鏈緱鍒拌璇併€傚仴搴风偣鍙戝竷鐨勩€婁腑鍥藉尰鐤椾汉宸ユ櫤鑳戒骇涓氭姤鍛娿€嬩篃鎻愬埌锛屾寜鐓у尰鐤楀櫒姊版敞鍐屾祦绋嬶紝浜у搧浠庣敵鎶ュ埌鏈€缁堣繃瀹¤缁忚繃浜у搧瀹氬瀷銆佹娴嬨€佷复搴婅瘯楠屻€佹敞鍐岀敵鎶ャ€佹妧鏈璇勩€佽鏀垮鎵圭瓑鍏銆傜洰鍓嶏紝鐢虫姤涓夌被鍣ㄦ鐨勫尰鐤椾汉宸ユ櫤鑳戒骇鍝佸ぇ澶氬仠鐣欏湪娉ㄥ唽鐢虫姤璧锋闃舵銆?/p>

鎺ㄦ兂绉戞妧缇庡浗鍒嗛儴璐熻矗浜洪倱鏄辨灚鍛婅瘔鍋ュ悍鐐癸紝FDA鍜孋FDA璁よ瘉杩囩▼涓嶄細鏈夊お澶у樊寮傦紝闅惧害鐩镐技銆備富瑕佽繕鏄湅鍖荤枟鍣ㄦ鐨勫畨鍏ㄦ€у拰鏈夋晥鎬э紝鑷充簬瀹℃壒閫熷害鍙栧喅浜庝骇鍝佺殑棰勬湡鐢ㄩ€斻€佷娇鐢ㄧ幆澧冦€佽蒋浠堕闄╃瓑銆?/p>

鍚屾牱鎵庢牴浜庡尰鐤椾汉宸ユ櫤鑳借涓氱殑鍥剧帥娣辩淮涔熷湪绉瀬鐢宠涓夌被鍖荤枟鍣ㄦ璁よ瘉銆傛嵁浜嗚В锛岀洰鍓嶅浘鐜涙繁缁寸殑鑲虹粨鑺備骇鍝佸凡缁忛€氳繃浜嗗師CFDA浜岀被鍖荤枟鍣ㄦ璁よ瘉锛屽苟涓旀鍦ㄧ敵璇?FDA鍣ㄦ璁よ瘉銆?/p>

瀵逛簬 CFDA 鏇村悕NMPA锛屽浘鐜涙繁缁磋仈鍚堝垱濮嬩汉鍏糃TO楂樺ぇ灞辫〃绀猴紝“浣滀负浼佷笟鏉ヨ锛屽璇勫鎵规祦绋嬫洿鍔犲揩鎹锋柟渚夸篃浼氱粰AI鍖荤枟浼佷笟甯︽潵姝e悜浣滅敤銆?rdquo;

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