“???????????????”

????,?????????????,2013????????235.98???,????????????,???????????????,?????????????

?????????,2012??1500?????IMS??,???????????????2007??7%,???2015?? 25%????,??????????????????????????,2012—2015?,????????770??????????????,???????????????,???????,????????,????????????????,??????????,?????????????????,?????????????????????,??????,??????????????,?????????????????????

??,???????????????????????,??????????????(cGMP)????????????????????,????????????????,??,?????????????????,????????“????”,???????????????

?????????????,2006?,???????????????“?????????”????????,???“??????????????”????

??????,?????????

????????????????90????????,????????????????,?????cGMP???????,??6????????????FDA??,483???????11????????0??

???????????????????,2004??????????????“????????”????????????

2006?7?,?????????????????????????“???????????”??,?????????????????????????

2007?,??????2.6??,???????????????????????,????????GMP/??cGMP????????????,???????????cGMP???????????????33155???,?????46480???,?????????,???5??;????QC??????????(????????????????)????????

?????????FDA???CFDA GMP?????????,?????????EHS(????????)???????????,?????FDA???CFDA ?????,???FDA???????????????????????????????

????????????????,???????????????????????,??????,???????????,???86%??????????????,77%??????????????

??????????????,???????????????????,???????,?????????,???????cGMP???????;???????????????,?????????????

??SOP????,????cGMP????????????????????(CAPA),??????????????????;????????????,?????????????????????????????????,???????????,????cGMP????,??????????????????????????cGMP??????

?????????????????????,?????????????????????,??????,????????????,?????FDA??2-3?ANDA???????,????6???,???????????????????????????????????????????????????????????????????,???????????,??????,??????????

????????EHS????,????“?????????,????”???,?????????????????,???????????????????????,??GMP???????????????

?????????????

2008?9?,?????????????
2009?3?,????????,????????????,?????
2009?9??????????????????????????,??FDA???
2010?1?,??????GMP???
2011?6?,?????????FDA????,9???FDA??,11???ANDA??,??????????????????????????,?????????????????????
2012?1?,?????????????????????????,??????????????????
2012?1?,????????????,???????
2012?4?,??????????????“??????????????????”???
2012?10?,?????????????(??)????,?????????????????,????????,????????????????????,??????,?????????????
2013?1???????GMP???
2013?11?,??????????????,?????????????????,?????????????????,???????????????
2014?4?,??FDA????????????,???ANDA??????,??????????????????,???????????

???????????

?????????,??5?,???????????3%~6%???,???????10-15%?????,????,????????????????????????FDA????EMEA??,??????????????????????

?????,???????????????????,????????????????,?????????????,???????????????,?????2030??????????????????????????????????,?????“???”????,?????????????????,????????,?????????

????88????,?????????????????,??????????????????????????????????,?????????,????,???????10??,?????????????,?????????????????????

????????,????,??????????????????????????????????????????????,??????????,2012???????????300???,???2014???????1000????

????????????,????????FDA ANDA????????,?????????????????ANDA??????,????????????,???ANDA????????????????????????????,????????,???????????????????????

?????????????????????,????????????,??????????????,??????????????,???????????????????????,???????????????????????????????????????????????????,??????,???????????,????????????????????