The International Council for Harmonisation (ICH) last month released a draft M13A guideline which proposes harmonized bioequivalence (BE) testing of new orally administered immediate-release (IR) solid oral drugs and assessing BE after post-approval changes.
The guideline covers the scientific and technical aspects of study designs used to support BE assessments; it does not address pharmacokinetic (PK) study designs or data analytics to support BE assessments. The guideline was released for public consultation on 20 December.
Harmonizing BE study design “would benefit both innovator and generic product developers as the same scientific approach could be followed in multiple jurisdictions, potentially reducing duplicative work,” according to an ICH concept paper released in 2020. “Patients would also benefit as harmonisation would help regulatory agencies in the timely authorisation and availability of quality, safe and effective drugs based upon harmonised acceptance criteria.”
While most regulators have BE guidelines in place and follow similar assessment approaches, “there remain some significant differences that hamper global harmonisation of drug development,” the paper states…
