±±¾©Ê¯ÓÍ»¯¹¤Ñ§Ôº2026ÄêÑо¿ÉúÕÐÉú½ÓÊÕµ÷¼Á¹«¸æ
²é¿´: 4913  |  »Ø¸´: 26
µ±Ç°Ö»ÏÔʾÂú×ãÖ¸¶¨Ìõ¼þµÄ»ØÌû£¬µã»÷ÕâÀï²é¿´±¾»°ÌâµÄËùÓлØÌû

³ÕÃÎäìÏæ

ľ³æ (ÖøÃûдÊÖ)


[½»Á÷] רÀûÑÓÆÚÓëÊг¡¶ÀÕ¼ ÒÑÓÐ19È˲ÎÓë

רÀûÑÓÆÚ£¨Patent Term Restoration£©ÓÉרÀûÓÉPTOÅú×¼£¬Êг¡¶ÀռȨ£¨Exclusivity£©ÓÉFDAÅú×¼£¬¶þÕß×÷ÓÃÏàËÆ£¬³ý¶ù¿ÆÓÃÒ©Í⣬¶þÕß»¥²»Ïà¸É¡£Èç¹ûij¸ö²úƷûÓÐרÀû±£»¤£¬ÒÀÈ»¿ÉÒÔÏíÊÜÊг¡¶ÀռȨ¡£Êг¡¶ÀռȨһ°ã²»ÑÓ³¤×¨Àû±£»¤ÆÚ£¬µ«¶ù¿ÆÓÃÒ©³ýÍ⣬¼´¿ÉÒÔÔÚרÀû±£»¤ÆÚÉÏÔö¼Ó6¸öÔ¡£¸÷ÀàÒ©Æ·Êг¡¶ÀÕ¼ÆÚ¸÷²»Ïàͬ£º
¹Â¶ùÒ©£¨Orphan Drug£©¡ª¡ª7Äê
л¯Ñ§ÊµÌ壨New Chemical Entities£©¡ª¡ª5Äê
мÁÐÍ¡¢ÐÂÊÊÓ¦Ö¢¡¢´¦·½Ò©±ä·Ç´¦·½¡ª¡ª3Äê
µÚÒ»¸ö·ÂÖÆÒ©¡ª¡ª180Ìì
¶ù¿ÆÓÃÒ©¡ª¡ª6¸öÔ£¨¿ÉÔÚרÀû±£»¤ÆÚÉÏÔö¼Ó6¸öÔ£©
²úÆ·±»FDAÅú×¼ºó60ÌìÄÚ£¬¿ÉÒÔÏòPTOÌύרÀûÑÓÆÚÉêÇ룬ÓÉFDA¸¨ÖúPTO¾ö¶¨×¨ÀûÑÓ³¤ÆÚÏÞ¡£×¨ÀûÑÓ³¤ÆÚÏÞÓëÇ¿ÖÆÉó²éÆÚ£¨Regulatory Review Period£©Óйأ¬Ç¿ÖÆÉó²éÆÚÓÉÁ½²¿·Ö¹¹³É£¬¼´ÊÔÑé½×¶Î£¨´ÓINDÉêÇëµ½NDAµÝ½»£©ºÍÉóÅú½×¶Î£¨´ÓNDAµÝ½»µ½FDAÅú×¼£©£¬¾ßÌåËã·¨ÊÇ£º
רÀûÑÓ³¤ÆÚ=ÊÔÑé½×¶ÎºÄʱ/2+ÉóÅú½×¶ÎºÄʱ
רÀûÑÓÆÚ×î¶à5Ä꣬²úÆ·ÉÏÊкóµÄÕû¸ö±£»¤ÆÚ²»³¬¹ý14Äê¡£ÀýÈç¾­¹ý¼ÆË㣬ij²úƷרÀû¿ÉÑÓÆÚ5Ä꣬µ«ËüÉÏÊÐʱʣÓàרÀû±£»¤ÆÚΪ10Ä꣬ÄÇô¸ÃרÀûÖ»ÄÜÑÓÆÚ4Äê¡£
×îÓÐȤµÄÊǸù¾ÝHatch-Waxman Act£¬·ÂÖÆÒ©ÉÌ¿ÉÒÔÔÚҩƷרÀûµ½ÆÚǰÏòFDAÉêÇë·ÂÖÆÒ©£¬×¨ÀûÒ©ÉÌÒ²ÓÐȨÔÚ45ÌìÖ®ÄÚÒÔÇÖ·¸×¨ÀûȨÌá³öËßËÏ£¬·´¶Ô·ÂÖÆÒ©µÄÉêÇë¡£Èç¹ûÁ¢°¸£¬FDA²»µÃÔÚÕùÒéÆÚͨ¹ýADNA£¬³ý·ÇÓÚ30¸öÔÂÄڽ᰸¡£ÓÚÊÇÓÐÈËÏë³öÁËÆµ·±ËßËÏ·¨£¬Ö»Òª×¨ÀûÂÉʦ¹»Ë®Æ½£¬¾Í¿ÉÒÔÍÏÑÓÊýÄê¡£2003Äêºó£¬¸Ã©¶´±»ÐÞÕý£¬×¨ÀûÒ©É̱ØÐëÒ»´Î30¸öÔÂÄÚ½â¾öרÀû¾À·×¡£
ÕâÑù×îÀíÏëÇé¿ö£¬Ò»¸öNCEµÄרÀû±£»¤ÆÚ¿É´ï20£¨»ù±¾×¨Àû±£»¤ÆÚ£©+5£¨×î¸ßרÀûÑÓ³¤ÆÚ£©+6¸öÔ£¨¶ùͯÓÃÒ©£©+30¸öÔ£¨×¨Àû¾À·×ÆÚ£©=28Äê¡£µ±È»Êµ¼ÊÇé¿öÊDz»¿ÉÄܵģ¬Ò»°ãÊÇ»ù±¾×¨Àû±£»¤20Ä꣬Íâ¼ÓÓÐЧרÀûÑÓÆÚ2-3Ä꣬ÀýÈçÒÁÂíÌæÄáרÀûÉêÇëÓÚ1993Ä꣬2015Äêµ½ÆÚ£¬Èç¹ûÄܽÁ½ø×¨Àû¾À·×£¬¿ÉÄÜÔÙÑÓ³¤¼¸¸öÔ¡£×î²»Ðҵĵ±È»ÊÇÒ©»¹Ã»ÉÏÊУ¬×¨Àû¹ýÆÚÁË£¬ÃÀ¹úºÃ´õ»¹ÓÐ5Äê»ò7ÄêµÄÊг¡¶ÀÕ¼ÆÚ£¬ÆäËû¹ú¼Ò¾ÍÄѰìÁË¡£

Á½¸öÃÀ¹úFDAµÄÎļþ+һƪÖйúµÄÏà¹ØÂÛÎÄ£º[ Last edited by ³ÕÃÎäìÏæ on 2013-1-13 at 21:43 ]

¹ØÓÚÖйúµÄÐÐÕþ±£»¤ÓëרÀû±£»¤¼û£º
http://blog.sina.com.cn/s/blog_af34cba10101dc8v.html

[ Last edited by ³ÕÃÎäìÏæ on 2013-4-17 at 11:30 ]
»Ø¸´´ËÂ¥

» ±¾Ìû¸½¼þ×ÊÔ´Áбí

» ÊÕ¼±¾ÌûµÄÌÔÌûר¼­ÍƼö

ÐÂÒ©Ñз¢±Ø±¸×ÊÁÏ ¡®Ò©Îï¡¢ÓлúºÏ³ÉÑо¿Ô±¡¯×ÊÁÏ´óÈ« Ñз¢¹¤ÒÕ Ó°ÊÓ·½Ãæ
New Drug Research and Development ÐÂÒ©Ñз¢ ½ø¿ÚÒ©Æ·×¢²á Ò©ÑÐÎöÒÉ
ºÜÓÐÓà ҩÑÐ ÊÕ¼ ·ÂÒ©
ÐÅÏ¢¼ìË÷ ´ýÏÂÔØ ÎÒµÄÌÔÌùר¼­ »Ø¸´
×¢²áÉ걨

» ±¾ÌûÒÑ»ñµÃµÄºì»¨£¨×îÐÂ10¶ä£©

» ²ÂÄãϲ»¶

ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû

taizicun

Òø³æ (ÖøÃûдÊÖ)

¡ï
Сľ³æ: ½ð±Ò+0.5, ¸ø¸öºì°ü£¬Ð»Ð»»ØÌû
ÒýÓûØÌû:
3Â¥: Originally posted by ³ÕÃÎäìÏæ at 2013-01-13 12:42:55
Êг¡¶ÀÕ¼ÆÚÊÇFDAÔÚÅú×¼ÉÏÊÐʱ¸øµÄ£¬ÓëרÀû±£»¤ÆÚ²»Äܵþ¼Ó£¬Ï൱ÓÚ²¢ÐÐË«±£ÏÕ£¬Ö»ÒªÁ½ÕßÓÐÒ»¸öÔÚ£¬·ÂÖÆÒ©¾Í²»ÄÜ»ñÅú¡£±ÈÈçij¸ö¹Â¶ùÒ©ÉÏÊÐʱרÀûÒѹýÆÚ£¬µ«ËüÈÔÓÐ7ÄêFDAÊÚÓèµÄ±£»¤ÆÚ¡£¶ù¿ÆÓÃÒ©³ýÍ⣬ÓÐרÃŵķ¨Âɹ涨 ...

лл¹þ£¬ÒÔǰһֱ¶¼ÊÇÒ»Öª°ë½âÖÐ
¶«£¬·Ç³£µÀ~
4Â¥2013-01-13 12:45:31
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû
²é¿´È«²¿ 27 ¸ö»Ø´ð

taizicun

Òø³æ (ÖøÃûдÊÖ)

¡ï
Сľ³æ: ½ð±Ò+0.5, ¸ø¸öºì°ü£¬Ð»Ð»»ØÌû
"Êг¡¶ÀռȨһ°ã²»ÑÓ³¤×¨Àû±£»¤ÆÚ"
Êг¡¶ÀռȨÆðʼÈÕÆÚÊÇרÀûµ½ÆÚÈÕ£¨»òרÀûÑÓÆÚµ½ÆÚÈÕ£©Âð£¿
¶«£¬·Ç³£µÀ~
2Â¥2013-01-13 12:16:53
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû

³ÕÃÎäìÏæ

ľ³æ (ÖøÃûдÊÖ)


ÒýÓûØÌû:
2Â¥: Originally posted by taizicun at 2013-01-13 12:16:53
"Êг¡¶ÀռȨһ°ã²»ÑÓ³¤×¨Àû±£»¤ÆÚ"
Êг¡¶ÀռȨÆðʼÈÕÆÚÊÇרÀûµ½ÆÚÈÕ£¨»òרÀûÑÓÆÚµ½ÆÚÈÕ£©Âð£¿

Êг¡¶ÀÕ¼ÆÚÊÇFDAÔÚÅú×¼ÉÏÊÐʱ¸øµÄ£¬ÓëרÀû±£»¤ÆÚ²»Äܵþ¼Ó£¬Ï൱ÓÚ²¢ÐÐË«±£ÏÕ£¬Ö»ÒªÁ½ÕßÓÐÒ»¸öÔÚ£¬·ÂÖÆÒ©¾Í²»ÄÜ»ñÅú¡£±ÈÈçij¸ö¹Â¶ùÒ©ÉÏÊÐʱרÀûÒѹýÆÚ£¬µ«ËüÈÔÓÐ7ÄêFDAÊÚÓèµÄ±£»¤ÆÚ¡£¶ù¿ÆÓÃÒ©³ýÍ⣬ÓÐרÃŵķ¨Âɹ涨¡£

[ ·¢×ÔÊÖ»ú°æ http://muchong.com/3g ]
3Â¥2013-01-13 12:42:55
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû

²»ÖªµÀ1

Ìú¸Ëľ³æ (ÕýʽдÊÖ)

Ì«ºÃÁË£¬Ð»Ð»·ÖÏí¡£

[ ·¢×ÔÊÖ»ú°æ http://muchong.com/3g ]
6Â¥2013-01-13 19:41:31
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû
×î¾ßÈËÆøÈÈÌûÍÆ¼ö [²é¿´È«²¿] ×÷Õß »Ø/¿´ ×îºó·¢±í
[¿¼ÑÐ] ÕÅ·¼Ãú-Öйúũҵ´óѧ-»·¾³¹¤³Ìר˶-298 +4 ÊÖ»úÓû§ 2026-03-26 4/200 2026-03-28 07:17 by mmm just
[¿¼ÑÐ] 295Çóµ÷¼Á +5 1428151015 2026-03-27 6/300 2026-03-28 04:04 by fmesaito
[¿¼ÑÐ] Çóµ÷¼Á +8 ÕÅzz111 2026-03-27 9/450 2026-03-28 03:41 by fmesaito
[¿¼ÑÐ] ¡¾Çóµ÷¼Á¡¿085601²ÄÁϹ¤³Ìר˶ | ×Ü·Ö272 | +5 ½Å»¬µÄÊØ·¨¹«Ãñ 2026-03-27 5/250 2026-03-27 22:50 by lcl13500..
[¿¼ÑÐ] 085602 307·Ö Çóµ÷¼Á +6 ²»ÖªµÀ½Ðʲô£¡ 2026-03-26 6/300 2026-03-27 22:00 by ´ß»¯´ó°×
[¿¼ÑÐ] 265Çóµ÷¼Á11408 +3 ÁõС¹lu 2026-03-27 3/150 2026-03-27 20:53 by nihaoar
[¿¼ÑÐ] ²ÄÁÏÇóµ÷¼Á +8 @taotao 2026-03-21 8/400 2026-03-27 11:21 by wangjy2002
[¿¼ÑÐ] ¿¼Ñе÷¼Á +9 СÀ¯ÐÂ±Ê 2026-03-26 9/450 2026-03-27 11:10 by ²»³Ôô~µÄ؈
[¿¼ÑÐ] Ò»Ö¾Ô¸¼ª´ó071010£¬316·ÖÇóµ÷¼Á +3 xgbiknn 2026-03-27 3/150 2026-03-27 10:36 by guoweigw
[¿¼ÑÐ] ²ÄÁÏѧ˶333Çóµ÷¼Á +8 ±±µÀÏï 2026-03-24 8/400 2026-03-27 10:18 by ÎÒÊÇС¿µ
[¿¼ÑÐ] µ÷¼ÁÇóÊÕÁô +7 ¹ûÈ»ÓÐÎÒ 2026-03-26 7/350 2026-03-27 00:26 by wxiongid
[¿¼ÑÐ] 085602 289·ÖÇóµ÷¼Á +8 WWWÎ÷Î÷¸¥Ë¹ 2026-03-24 8/400 2026-03-26 16:33 by ²»³Ôô~µÄ؈
[¿¼ÑÐ] 263Çóµ÷¼Á +6 yqdszhdap£­ 2026-03-22 10/500 2026-03-26 13:11 by ¹«èªåÐÒ£
[¿¼ÑÐ] 26¿¼ÑÐ-291·Ö-ÏÃÃÅ´óѧ£¨085601£©-ÈáÐÔµç×ÓѧԺ²ÄÁϹ¤³ÌרҵÇóµ÷¼Á +3 min3 2026-03-24 4/200 2026-03-25 18:22 by xcjcqu
[¿¼ÑÐ] ÉϺ£µçÁ¦´óѧ²ÄÁÏ·À»¤ÓëвÄÁÏÖØµãʵÑéÊÒÕÐÊÕµ÷¼ÁÑо¿Éú£¨²ÄÁÏ¡¢»¯Ñ§¡¢µç»¯Ñ§£¬»·¾³£© +4 ÎÒ°®Ñ§µç³Ø 2026-03-23 4/200 2026-03-25 00:59 by 1027_324
[¿¼ÑÐ] 0703»¯Ñ§µ÷¼Á£¬Çóµ¼Ê¦ÊÕ +7 ÌìÌìºÃÔËÀ´Éϰ¶° 2026-03-24 7/350 2026-03-24 20:26 by peike
[¿¼ÑÐ] 328Çóµ÷¼Á +4 LHHL66 2026-03-23 4/200 2026-03-23 14:55 by lbsjt
[¿¼ÑÐ] Çóµ÷¼ÁԺУÐÅÏ¢ +6 CX 330 2026-03-21 6/300 2026-03-22 15:25 by ÎÞи¿É»÷111
[¿¼ÑÐ] Çóµ÷¼Á +4 ÒªºÃºÃÎÞÁÄ 2026-03-21 4/200 2026-03-21 18:57 by ѧԱ8dgXkO
[¿¼ÑÐ] Çóµ÷¼Á +3 .m.. 2026-03-21 4/200 2026-03-21 16:25 by barlinike
ÐÅÏ¢Ìáʾ
ÇëÌî´¦ÀíÒâ¼û