ÈËÉú¾ÍÊDz«

NTEKÈËÉú¾ÍÊDz«¼ì²â¼¯ÍÅ

Ä¿½ñλÖà : Ê×Ò³ > ÈËÉú¾ÍÊDz«Ð§ÀÍ> ²úÆ·ÖÖ±ð> ʳÎï½Ó´¥ÖÊÁÏ

ÈËÉú¾ÍÊDz«Ð§ÀÍ

ÁªÏµÈËÉú¾ÍÊDz« +

ЧÀÍÈÈÏß 400-800-6106
ÈËÉú¾ÍÊDz«¼¯ÍÅ ¡¤ ×ܲ¿
µç»°£º0755-23200050 ÓÊÏ䣺ntek@ntek.org.cn ¹ã¶«Ê¡ÉîÛÚÊб¦°²ÇøÐÂÇŽֵÀÏóɽÉçÇøÐ·¢¶«Â·24ºÅ

ÃÀ¹úʳÎï½Ó´¥ÖÊÁϼì²â

»ù±¾ÏÈÈÝ

ÏàʶÓëÍâÑóʳÎï½Ó´¥ÖÊÁÏÏà¹ØµÄÇå¾²ÖÎÀíģʽºÍÖ´ÂÉÀýÔò £¬£¬£¬£¬£¬ÔöÇ¿¶ÔʳÎï½Ó´¥ÖÊÁϵÄÖÊÁ¿¿ØÖÆ £¬£¬£¬£¬£¬ÕâЩ¶ÔÖйúÆóÒµµÄ¶ÔÍâÉÌÒµÔ˶¯ÓÐ×ÅÖ÷ÒªÒâÒå¡£¡£¡£
ÈËÉú¾ÍÊDz«Êǹú¼Ê¹«ÈϵÄÖÊÁ¿ºÍ³ÏÐŵÄÈ«Çò»ù×¼ £¬£¬£¬£¬£¬Ê¼ÖÕ×ßÔÚÐÐÒµµÄǰ¶Ë£»£»£»£»ÒÀ¸½±é²¼È«ÇòµÄÊÖÒÕÖ§³ÖÆ½Ì¨ÍøÂç £¬£¬£¬£¬£¬×÷ÓýÁËÈËÉú¾ÍÊDz«½¹µã¾ºÕùÁ¦¡£¡£¡£ÈËÉú¾ÍÊDz«È«ÇòµÄÏà¹Ø×¨ÒµÈËÊ¿¿É·ÖÏí¸÷×Ô¹ú¼ÒµÄʳÎï½Ó´¥ÖÊÁϹæÔò £¬£¬£¬£¬£¬ÐÎÓñ³ÉÇòÍêÉÆµÄһվʽ½â¾ö¼Æ»® £¬£¬£¬£¬£¬ÖúÁ¦ÆóÒµ½µµÍÎ¥¹æÎ£º¦ £¬£¬£¬£¬£¬Ë³Ëì½øÈë¹ú¼ÊÊг¡¡£¡£¡£

ÓªÒµÌôÕ½

ÏÖÔÚ £¬£¬£¬£¬£¬ÒòʳÎï½Ó´¥ÖÊÁϺ¬ÓÐÓк¦ÎïÖʶøÒý·¢µÄʳÎïÇå¾²ÎÊÌâÒ»ÔÙ±¬·¢¡£¡£¡£¡°ËÜ»¯¼Á¡¢Ë«·ÓA¡¢ÖؽðÊô¡±µÈ׍ָÃû´ÊÒ»ÔÙ·ºÆðÔÚ¹«ÖÚÊÓÒ°ÖÐ £¬£¬£¬£¬£¬ÔÚ¹Ø×¢Ê³ÎïÇ徲ʱ £¬£¬£¬£¬£¬Ê³Îï½Ó´¥ÖÊÁϵÄÇå¾²ÎÊÌâÕýÈÕÒæÊܵ½Éç»á¸÷½çµÄÆÕ±éÖØÊÓ¡£¡£¡£
ʳÎï½Ó´¥ÖÊÁϹØÓÚʳÎïÇå¾²ÓÐ×ÅË«ÖØÒâÒ壺һÊǺϹæµÄÖÊÁÏ¿ÉÒÔ±£»£»£»£»¤Ê³Îï²»ÊÜÍâ½çµÄÎÛȾ £¬£¬£¬£¬£¬¼á³ÖʳÎï×Ô¼ºµÄË®·Ö¡¢ÒòËØ¡¢Æ·ÖʵÈÌØÕ÷²»±¬·¢¸Ä±ä£»£»£»£»¶þÊÇÖÊÁÏ×Ô¼ºµÄ»¯Ñ§ÒòËØ»áÏòʳÎïÖб¬·¢Ç¨áã £¬£¬£¬£¬£¬µ±Ç¨áãÁ¿Áè¼ÝÒ»¶¨ÏÞÁ¿Ê± £¬£¬£¬£¬£¬»áÓ°ÏìÓëÆä½Ó´¥µÄʳÎïµÄÎÀÉúÇå¾²¡£¡£¡£ÄúµÄ²úÆ·Öª×ãÃÀ¹úʳÎï¼¶²âÊÔÒªÇóÁËÂ𣿣¿£¿ÈôÊÇÄúÉÐδÏàʶÃÀ¹úʳÎï¼¶µÄ²âÊÔÒªÇó £¬£¬£¬£¬£¬ÒÔ¼°ÉÐδȡµÃ¼ì²â±¨¸æ £¬£¬£¬£¬£¬ÇëËæÊ±×ÉѯÎÒÃÇ £¬£¬£¬£¬£¬ÈËÉú¾ÍÊDz«½«È«Á¦Ð­ÖúÄú¡£¡£¡£

ЧÀÍÄÚÈÝ

ÊÊÓòúÆ·¹æÄ£

³øµç²úÆ·ÖÐÓëʳÎﱬ·¢½Ó´¥µÄÖÊÁϲ¿¼þ¼°Ô­ÖÊÁÏ¡£¡£¡£


ͨÀýÑùÆ·ÒªÇó

ǨáãÏîÄ¿°´Íâò»ý £¬£¬£¬£¬£¬º¬Á¿ÏîÄ¿°´¿ËÖØ»®·Öƾ֤²âÊÔÏîÄ¿Ìá¹©ÖÆÆ·»òÔ­ÖÊÁÏ £¬£¬£¬£¬£¬ËùÐèÊýĿȡ¾öÓÚ²úÆ·ÐÎ×´¡¢¾ÞϸÓëÏêϸ¼ì²âÏîĿҪÇó £¬£¬£¬£¬£¬¾´Çë×ÉѯÈËÉú¾ÍÊDz«ÔÚÏ߿ͷþ¡£¡£¡£


²âÊÔ±ê×¼
FDA 21, CFR 170-189¡£¡£¡£

½â¾ö¼Æ»®

Õë¶ÔÈ«Çò¸÷¹úºÍµØÇø¶ÔʳÎï½Ó´¥ÖÊÁϵIJî±ðÒªÇó £¬£¬£¬£¬£¬ÈËÉú¾ÍÊDz«ÌṩÖÜÈ«µÄµç×ÓµçÆø²úƷʳÎï½Ó´¥ÖÊÁÏһվʽ½â¾ö¼Æ»®£º
1. ÖÊÁÏ/²¿¼þ²âÊÔ
2. Õû»ú²âÊÔ
3. Åàѵ¼°×ÉѯЧÀÍ

ЭÖúÆóÒµ½µµÍ²úÆ·Î¥¹æÎ£º¦ £¬£¬£¬£¬£¬È·±£²úÆ·×îÖÕ˳Ëì½øÈëÃÀ¹úÊг¡¡£¡£¡£

ÈËÉú¾ÍÊDz«ÈÏ֤ЧÀÍ

ÈËÉú¾ÍÊDz«ÓÅÊÆ

ÈËÉú¾ÍÊDz«¼ì²âЧÀÍÓÅÊÆ

ЧÀÍÁ÷³Ì

ЧÀÍÁ÷³Ì

³£¼ûÎÊÌâ

1¡¢½øÈëÃÀ¹úÊг¡µÄʳÎï½Ó´¥ÖÊÁϺÍÖÆÆ·ÐèÇкÏʲôҪÇ󣿣¿£¿
´ð£ºÆ¾Ö¤ÃÀ¹úÁª°îʳÎïÒ©Æ·»¯×±Æ··¨(FFDCA) £¬£¬£¬£¬£¬Ê³Îï°ü×°ÖÊÁÏÊôÓÚʳÎïÌí¼Ó¼ÁÖÎÀíµÄ¹æÄ£ £¬£¬£¬£¬£¬ÓÉÃÀ¹úʳÎïÒ©Æ·ÖÎÀí¾Ö£¨FDA£©Í³Ò»ÖÎÀí £¬£¬£¬£¬£¬Ïà¹ØÒªÇóÁÐÈë¡¶Áª°î¹æÕ·¨µä¡·(Code of Federal Regulation, CFR)µÚ21¾í £¬£¬£¬£¬£¬ÏêϸÀ´ËµÐèÖª×ã21 CFR 170-189Õ½ڵÄÒªÇ󡣡£¡£

2¡¢²»ÔÚ¹æÔòÖÐÒÑÅú×¼µÄÖÊÁÏÇåµ¥ÖеÄÖÊÁÏ¿ÉÒÔʹÓÃÂ𣿣¿£¿
´ð£ºÈκνøÈëÊг¡µÄÐÂÖÊÁϱØÐè¾­FDAÉóºË¼°ÈϿɡ£¡£¡£
Á¬Ã¦×Éѯ »ñÈ¡±¨¼Û

»ñÈ¡±¨¼Û

¹«Ë¾Ãû³Æ£º *
ÄúµÄÐÕÃû£º*
ÄúµÄÊÖ»ú£º*
ÄúµÄÐèÇó£º*

*ΪÁËÄú µÄÈ¨Òæ £¬£¬£¬£¬£¬ÄúµÄÐÅÏ¢½«±» ÑϿᱣÃÜ

ÐÅÏ¢Ìá½»ÀÖ³É

רҵ¹¤³Ìʦ½«·É¿ìÁªÏµÄú £¬£¬£¬£¬£¬ÎªÄúÌṩºÏÊÊ ½â¾ö¼Æ»® £¬£¬£¬£¬£¬ÆÚ´ýÓëÄúÏàÓö~

΢ÐŹ«ÖÚºÅ
·ÖÏíÐÐÒµ¸É»õ
΢ÐÅ×Éѯ
Ç뱸ע×ÉѯЧÀÍ
¡¾ÍøÕ¾µØÍ¼¡¿