To further facilitate generic pharmaceutical product availability and to support the generic pharmaceutical industry with identifying the most appropriate methodology for designing the bioequivalence/ in-vitro studies, SFDA publishes product-specific guidance describing the Authority's current thinking and expectations on how to develop bioequivalence/ in-vitro studies for the generic pharmaceutical product.
Disclaimer: This guidance helps applicants meet the expectations of regulators. This guidance should not be understood as being legally enforceable. The applicant can use another approach if the approach satisfies the requirements of the GCC guideline of bioequivalence.