Table 1 Bioequivalence data requirements and biowaiver data acceptance by the selected RAs
Jurisdiction | Bioequivalence data requirement | Biowaiver data acceptance |
|---|---|---|
Australia | POM and for an identified list of OTC medicines. | BCS Class1drugs |
Canada | Required for all solid oral generic drugs | BCS Class1 and Class 3 drugs [7] |
EU | solid oral generic drugs | BCS Class1and Class 3 drugs [46] |
India | solid oral generic drugs | BCS Class 1 drugs and Schedule Y drugsa and drug already approved for new claims, new indication, new dosage form/ new route of administration, modified release dosage form [25] |
Japan | solid oral generic drugs. (In vivo BE is required for first approval of all generics). | Does not accept BCS-based biowaiver for first approval of generic drugs. Accepts dissolution studiesb for minor changes in the formulation and the dose strength |
Malaysia | solid oral generic drugs | BCS Class 1drugs. A list for which biowaiver can be considered is provided [16, 29] |
Singapore | POM and for over the counter medicines not included in the list of medicines exempted from BE | BCS Class 1drugs and for additional strengths of the drug if doses are proportional [8] |
South Korea | solid oral generic drugs | BCS Class 1 and Class 3drugs |
Sri Lanka | antiepileptic, narrow therapeutic index drugs, sustained release products and antimicrobials (from 2014) | Does not accept BW data |
USA | solid oral generic drugs |