Regulations for Registration of Medicinal Products Article 37

In situations where Bioavailability/Bioequivalence (BA/BE) studies are required for the application for drug registration, the study should comply with the Regulation of Ba and Be Studies in the aspects of the scope of drugs, items, reference standards, test principles, test period, principles for substitution and other matters in relation to the study.When conducting BA/BE studies, the applicant should comply with the central health competent authority’s regulation and fill out the application forms for the assessment of the BE study protocol and BE study report, the application forms for the assessment of the BA study protocol and BA study report, and for the assessment of the drug dissolution curve comparison report. The applicant should also prepare related information according to the requirements on those forms.