Hong Kong Drug Office has published a set of frequently asked questions on Phase 2 requirements of bioavailability (BA) and bioequivalence (BE) studies in July 2022.
There is an addition of information for the registration of critical dose drugs or narrow therapeutic range drugs (NTRD). There are 38 drugs in total and the BA/BE studies must be included as per the World Health Organization (WHO) guidance document.
The document provides further details on timeline and the dose form applicable for the Phase 2 requirements, as well as the exemptions related to the BA/BE requirements.
More details can be found in “Frequently Asked Questions and Answers on Phase 2 Requirement of Bioavailability and Bioequivalence Studies, July 2022”: https://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/FAQ_for_BABE_implementation_en.pdf