Requirement for Generic Drug

Europe Regulation

1.  Piggyback is allowed (originator)

2.  Literature  完整

3.  Essentially similar approach: B/E and originator product is still on the market

4.  Hybrid: 1, 2 and 3

 

Requirement for Generic Drug

1.  Pharmaceutical equivalence: acitve substance 量和原廠一樣多

Impurity < 0.1 % of acitive then isolation and identification is not required

2.  Bioequivalence: the same pharmacological effect (safety and efficacy)  + P/E

3. Essentially similarity