agºÍ¼Ç

À´Ô´£ºÄÚÒÂÄÐÊ¿°Ö°Ö £¬×÷Õߣº £¬£º

ÚÀ £¬ÎÒ¸úÄ㽲࣠£¬×î½üÎÒ´øÎÒ±íµÜ¿ËÁËÌË÷ÖÝÆ·²èÊÂÇéÊÒ £¬ÕæµÎÊÇÓÐÒâ˼¡£Õâ¼ÒµØ·½°¡ £¬ÌýÃû×Ö¾ÍÏþµÃ £¬¸ã²èµÄÂï £¬¶Ô°É£¿µ«ÄãǧÍò±ðÒÔΪí¥×Ó¼òµ¥ £¬½øÈ¥Ï¹×øÒ»¹þ¾ÍÍêÊÂÁË¡£ÀïÃæµÄ½²¾¿ £¬ßõ £¬¿ÉÒÔÈÆµÃ±È¹ðÁÖÍõ³ÇÀïµÄ·»¹ÅÓ´ó¿©¡£²»¹ý £¬ÕÕÎÒ¿´À´à£ £¬¶®µãÃŵÀ¾ÍºÃ £¬Ã»µÃÐëÒª¸ãµÃÏñÄîÊ鿼ÊÔÒ»Ñù½ôÕÅ¡£

÷ÖÝÆ·²èÊÂÇéÊÒ £¬ÊÇɶ×ÓζµÀ£¿

Õâ¸öÂï¡­¡­Ã·ÖÝÆ·²èÊÂÇéÊÒ £¬Õ¦ËµÄØ £¬Ó¦¸ÃËãÊǹðÁÖÈ˰®·¢»áñ²£¨Ïй䣩µÄÐÂÈ¥´¦¡£¹ðÁÖÈ˲»°®Æ·Üø£¿Äǿɲ»ÊÇ¿© £¬ÎÒÃǰ®Æ·Üø £¬µ«¸ü°®ºÈζµÀ¡£Ã·ÖÝÆ·²èÊÂÇéÊÒµÄζµÀ £¬²»¿ÉÊDzèÒ¶ÄǸöÏã £¬Õվɯø·ÕÄǸöÊæÐÄ¡£Äã½øµ½ÀïÍ· £¬¿´µ½ÄǼ¸¸öÀÏ²èºø¡¢Ä¾×À×Ó¡¢ÁíÓÐǽÉÏ¹ÒÆðµÄÄǵã¹Å»­ £¬ßõ £¬ÂíÉϾÍÏþµÃ £¬Õâ²»ÊÇÆÕͨµØ·½¡£

ÚÀ £¬ÎҼǵÃÓÐÒ»»Ø £¬ÄÇ¿­£¨Ì죩ÎÒ³ÔÍêÎç·¹ £¬Ëæ±ã·¢»áñ² £¬×ß½øÆ·²èÊÂÇéÊÒ £¬¿´µ½Ò»¸öʦ¸µÔÚÅÝÒ»ºøÌú¹ÛÒô¡£ÎÒ¸úËûÁÄÁËÒ»¹þ £¬ËûËÃ÷ÈÕâ¸öÌú¹ÛÒôÊÇ´Ó¸£½¨Ô˹ýÀ´µÄ £¬ÅÝÆðÀ´Î¶µÀÌØ±ðÕý×Ú¡£ÎÒ³¢ÁËÒ»¿Ú £¬ÕæµÎÊÇÓÐÄÇζ £¬¹ðÁֲ˵¶Çз۵ÄÄÇÖÖ´¿Ïã £¬à£~δ¼¸²»ÉÙ £¬¸ÕÇ¡ºÃ¡£

Ïà¹ØÍ¼Æ¬

Æ·²èµÄÃŵÀ £¬ÀϹðÁֵľ­Ñé

Ïà¹ØÍ¼Æ¬

½²µ½Æ·²è°¡ £¬Ðí¶àÈ˶¼ÒÔΪֻҪ²èÒ¶ºÃ¾ÍÐÐÁË¡£ÚÀ £¬Õâ¸öÏ뷨࣠£¬²»È«¶Ô¡£²èÒ¶ºÃÊÇǰÌá £¬µ«³å²èÊÖ·¨²ÅÊÇÒªº¦¡£Ã·ÖÝÆ·²èÊÂÇéÊҵIJèʦ¸µ £¬ËûÃÇÅݲèµÄÊÖ·¨ £¬ÎÒ¿´ÁËÒ»¹þ £¬ßõ £¬½²¾¿µÃºÜ£¡

Ïà¹ØÍ¼Æ¬ ͵͵¸æËßÄã࣠£¬ÅݲèÓиö¡°»Æ½ðÈý²½¡±£ºµÚÒ»²½ £¬Ë®ÎÂÒªÕÆÎպà £¬Ìú¹ÛÒôÒ»°ãÓÃ90¶ÈµÄË® £¬²»¿ÉÌ«ÌÌÒ²²»¿ÉÌ«À䣻µÚ¶þ²½ £¬²èÒ¶Á¿ÒªºÏÊÊ £¬×¥Ò»Ð¡´é¾Í¹»ÁË £¬±ð¸ãµÃÏñÖó·¹Ò»ÑùÂúÂúµÄ£»µÚÈý²½ £¬ÅݵÄʱ¼ä £¬µÚÒ»Åݲ»ÒªÁè¼Ý30Ãë £¬ºóÃæ¿ÉÒÔÉÔ΢³¤Ò»µã¡£Äã½²ÊÇûÊÇ¿©£¿¼òµ¥ÓÖʵÓᣠÏà¹ØÍ¼Æ¬

ÁíÓа¡ £¬Ã·ÖÝÆ·²èÊÂÇéÊҵIJè¾ßÒ²ÂùÓн²¾¿¡£Äã±ðÒÔÎªËæ±ãÄøö±­×Ó¾ÍÄÜÅݺòè £¬ÄÇÊDz»¿ÉÄܵĿ©¡£Ê¦¸µÒ»°ãÓÃ×Ïɰºø»òÕ߰״ɺø £¬×Ïɰºø±£Ïã £¬°×´ÉºøÄÜ¿´²èÌÀ £¬ßõ £¬ºÈÆðÀ´¸üÓÐζµÀ¡£Õâ¸ö½²¾¿ £¬µÖµÃÉÏÈýÆ·ÍõµÄ±²Ë·Û £¬ÖµµÃѧһ¹þ¡£

±ð¹âÆ·Üø £¬»¹ÒªÌý¹ÊÊÂ

ÚÀ £¬¶ÔÁË £¬Ã·ÖÝÆ·²èÊÂÇéÊÒÁíÓиöºÃÍæµÄµØ·½ £¬¾ÍÊÇÐí¶à²èʦ¸µÏ²»¶°ÚÁúÃÅÕó£¨ÁÄÌ죩¡£ÄãÒ»±ßÆ·Üø £¬Ò»±ßÌýËûÃǽ²¹Å×Ð £¬ºÃ±ÈÄÄ×ÓÀ´µÄ²èÒ¶¡¢ÄÄ×Ó¸ÄÁ¼µÄÅÝ·¨¡¢ÁíÓÐËûÃÇÔõô´ÓÍâµØ°ÑºÃ²è´ø»Ø¹ðÁÖ¡£Ìý×ÅÌý×Ű¡ £¬¾Í¾õµÃÆ·Üø²»¿ÉÊǺÈζµÀ £¬ÕվɺÈÎÄ»¯à£¡£

ÎҼǵÃÓдΠ£¬Ò»¸öʦ¸µ¸úÎÒ½² £¬ËûÄêÇá¿­£¨Ê±ºò£©¿ËÔÆÄÏѧ¹ý¼¸¸öÔµIJèÒÕ¡£»ØÀ´ºó £¬Ëû°ÑÔÆÄÏµÄÆÕ¶ý²èÅÝ·¨ £¬¸úÎÒÃǹðÁÖµÄÓͲèÎÄ»¯½áºÏÆðÀ´ £¬¸ã³öÁËÒ»ÖÖ¡°¹ðʽÆÕ¶ý¡±¡£ÚÀ £¬Õâ¸ö²èÅݳöÀ´ £¬Î¶µÀÓеãÏñÓͲè £¬µ«¸üÇåÏã £¬ºÈÁËÁ½±­ £¬Õû¸öÈ˶¼ËÉ¿ªÁË¡£Äã½² £¬ÕâÊDz»ÊǺÜÓÐÒâ˼£¿


×ܽáºÍÄã¿ÉÄÜÏëÎʵÄ

÷ÖÝÆ·²èÊÂÇéÊÒ࣠£¬ÕÕÎÒ¿´À´ £¬ÊǸöÖµµÃ¿ËÒ»¹þµÄµØ·½¡£²»¹ÜÄãÊǰ®Æ·ÜøÕվɰ®Ìý¹ÊÊ £¬×ÜÄÜÕÒµ½µãÈÃÄãϲ»¶µÄ¹¤¾ß¡£ÚÀ £¬ÓÐÈË¿ÉÄÜ»áÎÊÎÒ£ºÈç¹ûµÚÒ»´Î¿Ë £¬Ñ¡É¶×Ó²è±È½ÏºÃ£¿

ÎÒ¸úÄ㽲࣠£¬µÚÒ»´ÎÈ¥ £¬½¨ÒéÑ¡Ìú¹ÛÒô»òÕßÁú¾® £¬ÕâЩ²èζµÀÎÂºÍ £¬ÊʺÏÐÂÊÖ¡£±ð¸ãµÃÌ«ÅÓ´ó £¬ºÈ×ÅÊæÐľͺá£

±êÇ©£º

  • ÷ÖÝÆ·²èÊÂÇéÊÒ
  • ¹ðÁÖ²èÎÄ»¯
  • Æ·²èÃŵÀ
  • ÀϹðÁÖ¹Å×Ð
  • ²èÒÕÌåÑé

¡¶²è�ÓÐÅ®ÉúÅãÆ·ÜøÊǸÉʲô¡·

È»¶ø £¬ÎüÈë·ÛÎí¼Á×÷Ϊµä·¶µÄ¡°Ò©ÐµÒ»Ì塱¸ß¶ËÅÓ´ó·ÂÖÆÒ© £¬¼¼Êõ±ÚÀݼ«¸ß £¬ºã¾Ã±»¿ç¹úÒ©Æó¢¶Ï¡£Æä·ÂÖÆÃæÁÙÈýºÆ½ÙÌ⣺һÊÇÉúÎïµÈЧÐÔ¡°¾«¶È¿¼Ñ顱£ºÎüÈë·ÛÎí¼Áͨ³£¼ÁÁ¿Îª¡°Î¢¿Ë¼¶¡± £¬PK-BEÌåÄÚÁÙ´²ÊÔÑéÖÐ £¬Ò©Îï»îÐÔÉí·ÖÈëѪºóµÄѪҩŨ¶È½öΪ¡°Æ¤¿Ë¼¶¡± £¬ÒªÊµÏÖÓëÔ­ÑÐÒ©ÌåÄÚÍêÈ«ÉúÎïµÈЧ £¬¶ÔÖÆ¼ÁÅä·½¡¢Éú²ú¹¤ÒյĿØÖƾ«¶ÈÒªÇó½üºõ¿Á¿Ì£»¶þÊÇҩеЭͬ¡°ÊÊÅäÄÑÌ⡱£ºÁÆÐ§ÒÀÀµÒ©ÎïÓëÎüÈë×°Öõĸ߶ÈÊÊÅä £¬×°Öýṹ¡¢Ò©ÎïÓ븨Áϵľۼ¯ºÍÊèɢЧ¹ûÖ±½ÓÓ°ÏìÒ©ÎïÔڷβ¿µÄÓÐЧ³Á»ýÂÊ £¬¡°Ò©ÐµÒ»Ìå¡±ÌØÐÔ´ó·ùÌáÉýÑз¢ÅÓÆ¯ºóÓëÖÜÆÚ£»ÈýÊÇFDA¼à¹Ü¡°ÑÏ¿Á±ê×¼¡±£ºFDAÕë¶Ô´ËÀàÅÓ´ó·ÂÖÆÒ©£¨Complex generics£©¹«²¼×¨Êôµ¥Æ·Ö¸ÄÏ£¨Product-Specific Guidance £¬PSG£© £¬ÒÔÃãÀøºÍÔö½øÒ©Æó¿ªÕ¹ÅÓ´óÖÆ¼Á·ÂÖÆÑо¿ £¬Ö¸ÄÏÖжÔÒªº¦ÖÊÁ¿ÊôÐÔ£¨CQA£© £¬ÈçÌåÄÚÍâÉúÎïµÈЧÑо¿¡¢×°ÖÃÏàËÆ¶ÈµÈ×÷³öÑÏ¿Á»®¶¨ £¬ºË²éÈ«ÃæÏ¸Ö £¬Ì§¸ß×¼ÈëÃż÷¡£

¡¶Íþº£Æ·²èwx¸öÈËÖ÷Ò³¡·

2024Äê £¬È«¹úÑÝÒÕÊг¡È«ÃæËÕÐÑ £¬ÉîÌõÀíÎÄ»¯Ïû·ÑÐèÇó¼¯ÖÐÊÍ·Å¡£ÖÐÑÝÔºÏßÒÔÆìÏÂÖ±Óª¾çԺΪÒÀÍÐÌᳫȫ¹úÑÝÒÕÊг¡¹ÛÑÝÒâÏòÊÓ²ì £¬ÊÕ¼¯ÓÐЧµ÷ÅÌÎʾí3000Óà·Ý¡£ÊÓ²ìÆÊÎö±¨¸æÏÔʾ £¬ÖÐÇàÄêÅ®ÐÔȺÌåÊÇÑÝÒÕÊг¡µÄÖ÷Òª¹ÛÖÚ £¬Å®ÐÔ¹ÛÖÚÕ¼±È¸ß´ï80.49%¡£ÆäÖÐ £¬18ÖÁ30Ëê¹ÛÖÚÕ¼±È53.43% £¬31ÖÁ50Ëê¹ÛÖÚÕ¼±È39.18%¡£±ðµÄ £¬Áè¼ÝÈý·ÖÖ®Ò»µÄ¹ÛÖÚÓÐÎåÄêÒÔÉϽø¾çÔº¹ÛÑݵľ­Àú¡£

¡¶½úÖÝÆ·ÜøµÄµØ·½¡·

´ËʱÏÖÔÚ £¬¹â·üÆóÒÃ÷ÈÕý×ßÔÚ¸ÖË¿ÉÏ¡£×ó±ßÊÇÒòÒø¼Û±©ÕǶøµ¼ÖµÄÏÖ½ðÁ÷¶ÏÁÑ £¬ÓÒ±ßÊÇÒò¼¤½ø¼¼ÊõÌæ´ú¶øÂñϵÄÔ¶ÆÚµØÀס£ÎÞÂÛÄÄÒ»ÖÖ £¬¶¼ÐèÒªÖ§¸¶²ÒÖØµÄ¼ÛÇ®¡£

ÍøÕ¾µØÍ¼