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Table 1 Bioequivalence data requirements and biowaiver data acceptance by the selected RAs

From: Regulatory requirements for the registration of generic medicines and format of drug dossiers: procedures in Sri Lanka in comparison with selected regulatory authorities

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 cBCSClass1and3drugs [6, 47, 48]
  1. a New drugs which require human clinical pharmacology data for registration under the rules for Schedule Y of Drugs and Cosmetics rules of Central Drugs Standard Control Organization (CDSCO), India
  2. b Multimedia dissolution tests
  3. c For first time registration