The upcoming ICH M13B webinar will focus on the draft guideline titled “Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver,” which received endorsement from the International Council for Harmonisation (ICH) Assembly in March 2025. This guideline is pivotal for pharmaceutical professionals involved in the development and regulatory approval of generic drugs, as it outlines the criteria for biowaivers concerning additional strengths of existing formulations.
As the pharmaceutical landscape increasingly shifts towards streamlined regulatory processes, understanding the implications of the ICH M13B guideline is essential for regulatory affairs, quality assurance, and quality control professionals. The guideline aims to facilitate the approval of new strengths without the need for extensive clinical studies, thereby expediting market access while maintaining safety and efficacy standards.
For stakeholders in sourcing and CMC, this webinar presents an opportunity to gain insights into the regulatory expectations and scientific rationale behind the biowaiver process, which could significantly impact portfolio strategies and operational efficiencies in drug development.
