???? ?????? ????? ??? ??????? ???????? (???? ???????? ???? ??? ??????? ????????) ???? ?????? ???? ???? ??? ??????????? ??????? ?????????? ?? ???????? ???? ????? ??? 1995? ????? ????? ????? ????? 80 ????? ????? ?????? ????? ???? 40 ??? ??? ????. ???? ?????? ???? ?? 60 ?????? ?? ??????? ????? ???? ?? 20 ?????? ?????? ???? ?????? ?????? ?? ??????? ????????? ??? ???? ????? ??? ?????.

????? ???? ???? ??? ??????? ???? ????? ??????? ?? ???????? ??????? ????????? ????????? ?????? ?????? ??????? ????????? ??????? ???????? ????? ?? ????????? ???????? ??????? ????? ???????? ??? ?????? ????????? ??????? ???????? ?????? ???? ??? ????. ?? ????? ?????? ?????? ????? ????? ?? ???? ????? ?????? ?????? ????? ????? ????? ?? ???????? ???????? ??????? ???????? ?? ?????? ???????. ???? ?????? ???? ?? 70 ??? ????? ?? ??????? ????? ????? ?????? ??????? ??????? ????? ??????? GMP? ???? ????? ????? ????? ????? ??????? ??? ?????? ?? ????? ????? ?????? ?? ????????? ????????? ??? ??????? ?????????????? ???????? ??????? ???????? ???????? ???????? ???????????.

?? ?????? ??? ????? ????? ????? ????? ?????? GB/T19001-2000 ?? ????? ??? 2005? ??? ?????? ??? ????? ????? ????? ????? ?????? GB/T24001-2004 ?? ?????? ??? 2007? ??? ????? ????? ???????? GMP ???? ????. ?? ?????? ??? ????? ????? ?????? ??????? API ???????? ?? 4 ???? ??? 2011. ?? ?????? ????? ???????? ???????? ?? ?????? FDA ?? ????? ??? 2011? ??? ????? ?????????? ?????????????? ??????????? ???????????? ????????????? ????? ??? ?????? ?????????? ?????? ??????? ?????????? ?????? ????? NDC ???????? DMF ?EDMF ????????.

????? ???? ???? ??? ??????? ?????? ????? ??????? ?????? ?????? ????????? ?? ?????? ??????? ????????? ??????? ?????????? ???????. ??? ??? ???????? ???? ??????: ????? ????? ???????? ??????? ????????? ?????????????? ????? ??????????? ???? ?????????????? ???? ????? ????? ?????????? ??? ???? ???? ???????? ??????? ???? ?? 6 ?????? ????? ??????? ??? ????? ??????? ????????? ?? ?????? ?? ???????.

?? ??? 2021? ?? ????? ???? ?????? ????? ??? ??????? ???????? ?? ?????? ?????? ?????? ??? ???? ????? ????? ??????? 136 ??????? ?????? ??????? ?????? ?????? 1000 ?? ?? ?????? ??????? ????????? ??????? ??????? ?????? ??? ????? ????? ????? ?????? ?? ????? ????? ?????? ?????? ??????? ???????? ??? ?????? ????? ???? ?? 200 ??? ????? ???? 2000-5000 ???? ???????? ??? ???? ?? 50 ?????? ?? ????? ????? ???????? ???????? ???????. ?????? ????? ??????? ?????? ?? ??????? ??? ??? ????????? ??? ??????? ?? ???? ??????? ?? ????? ?????? ?? ??? 2022.

??? ???? ???? ???????? ???? ??? ??????? ??? ????? ????? ???????? ??? ???????? ??????? ?????????? ???????? ??? ?? ????? ?? ????? ??????? ???????? ?????????? ????? ??? ???????? ???????? ?????? ?????? ?????? ????? ??????? ?????? ????? ??????? ?????? ???????? ???? ???? ???????! ?? ?????? ??? 2011? ???? ?????? ??? ??? "???? ????? ?????"? ??????? ?????? ??????? ?????????? ?????? 3A ?????? ?????.