What dosage form of generic drugs can be exempt from the bioequivalence study?

刊登日期:2019-10-25  |  點閱次數 : 1372 次 
  1. According to Article 8 of the Regulation of Bioavailability and Bioequivalence Studies, bioequivalence study can be waived if the drug product meets any of the following circumstance:
  2. 1. Intravenous administrated injection product.
  3. 2. Oral administrated generic drug with excipients that do not affect absorption of the active ingredient.
  4. 3. Extravascular administrated injection product, i.e. the injectable solution of generic drug that have same pH value as compendia or brand products. Except for the preservatives and buffers, its formulation should be the same as the brand drugs.
  5. 4. Drug products as inhaled gases or vapors.
  6. 5. Generic drugs with topical uses that are not subcutaneously or intradermally absorbed.
  7. 6. Ophthalmic and otic generic drugs.
  8. 7. For same oral solid drug products with different strength applying for registration, or drug products with approved bioequivalence reports submitting for post-approval changes, the bioequivalence study can be replaced by dissolution profile comparisons if approved by the central competent health authority.
  9. 8. Others that are approved by the central competent health authority according to information provided by the applicants.



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