Generic Medicines的定義

1.  copies of previously prescription products

2.  expired or almost expired

3.  usually without proprietary names (non-proprietary)

without therapeutic misadventure

4.  EGMA: essentially similar

a.  having the same qualitative and quantitative composition in terms of active principles

b.  having the same pharmaceutical form

c.  being bioequivalent

 

ECJ:

 

1.  Chemical name

2.  Generic (non-proprietary) name

3.  Brand (proprietary) name: promotion

 

Eg. Lisinopril (Merck) -> Carace (DuPont) or Zestril (Zeneca)

 

Innovator products : usually one source (patent protection)

Proprietary

-Branded generic (multisource)

-Unbranded generic