Regulations of Bioavailability and Bioequivalence Studies Article 8

Bioequivalence study may be waived if the drug product meets any of the following circumstances:1. For injection product that is administered as solution where has same pH value as that of reference product or the specifications set forth in the pharmacopoeia, and contain qualitative the same excipients, except preservatives, buffers and antioxidants, and the quantity of the excipients should be within 5% of the amount in the reference product.2. For orally administered product that is delivered in solution form, as well as the reference product, does not contain any excipient which may affect absorption of active ingredient(s).3. For orally administered product that is delivered in solution form contain excipient(s) that may affect absorption of active ingredient, these excipient(s) are qualitative the same and quantitative similar as reference product.4. Drug products as inhaled gases or vapors.5. Topical solution product for application to the skin where the composition of excipients are qualitative the same as the reference product, the quantity of these excipients should be within 5% of the amount in the reference product, and the quality attributes are similar to the reference product.6. Ophthalmic and otic generic drugs.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 may be replaced by dissolution profile comparisons if approved by the central competent health authority.8. Others that are approved by the central competent health authority according to information provided by the applicants.