hng dn vic bo ch thuc generic c bo m, FDA, c quan qun tr dc phm v thc phm ca M,

c cc yu cu cn bn m c s bo ch thuc generic cn phi tun th nh sau:

1. Phi s dung cc nguyn liu nh thuc gc
2. Phi c cng cng hiu, liu lng s dng v cch thc s dng nh thuc gc
3. Phi c cng cc qui nh s dng nh thuc gc
4. Phi c bo ch di qui trnh sn xut nghim ngt GMP (Good Manufacturing Production )
Vi cc qui nh sn xut nh vy, FDA cn i hi thuc generic cn phi t c cc tiu chun cn bn sau
y:
1. C sc cng hiu nh thuc gc
2. C cng tnh cht, tinh khit v cng hiu nh thuc gc
3. C cng thi gian s dng cng hiu nh thuc gc
4. Gi bn phi r hn thuc gc
5. Phi c sn xut theo qui nh GMP
6. Phi c hnh thc bn ngoi khc vi thuc gc (v hnh thc bn ngoi ca thuc gc thng c cu chng nn khng
c lm ging hnh thc ca thuc gc) [4]