The Regulation is set according to the Second Paragraph of Article 42 of the Pharmaceutical Affairs Act.

The execution of bioavailability and bioequivalence and their related studies shall comply with the provisions of the Regulation. Matters not provided for herein should be governed by the Guidelines of Good Clinical Practice, the Regulation for Registration of Medicinal Products, and other relevant laws and regulations.

The terms used in the Regulation defined as follows:
1.Bioavailability means the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action. For drug products that are no intended to be absorbed into the blood stream, bioavailability may be assessed by measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of action.
2.Pharmaceutical equivalents means drug products in identical dosage forms that contain identical amounts of the identical active drug ingredient, and meets either the identical compendial or other applicable quality standards provided by the central competent health authority.
3.Pharmaceutical alternatives means drug products that contain the identical therapeutic moiety, or its precursor, but not necessarily in the same amount or dosage form or as the same salt or ester. Testing specifications of the drug product should meets either the identical compendial or other applicable quality standards provided by the central competent health authority.
Bioequivalence means the absence of a significant difference in the bioavailability between two pharmaceutical equivalents or pharmaceutical alternatives when administered at the same molar dose under similar conditions in an appropriately designed study.

Pharmaceutical manufacturers must apply for the approval of the protocol from the central competent health authority before conducting bioavailability and bioequivalence studies. The content of studies should comply with the Guideline of Good Clinical Practices. However, the application of protocol for conducting bioavailability and bioequivalence studies of generic drugs can be waived.

Application fees for applying any protocols and reports following the Regulation should be paid, and the completed application forms together with all required dossiers should be submitted to the central health competent authority for assessment.
The above-mentioned application forms and documents include the form of bioavailability study protocol, the form of bioequivalence study protocol, the form of bioavailability study report, the form of bioequivalence study report, the form of dissolution profile comparison report, and/or other forms and documents in relation to the application procedure.

Reports should be written in the format required by the central competent health authority, and a complete report with any relevant study results should be submitted for assessment.
Applicants should provide a written statement that test drugs are indeed the registered drugs. Applicants have the ultimate responsibility for the quality and integrity of study results.

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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.