Join our Webinar on Biopharmaceutics Classification System (BCS)-based Biowaivers. This webinar aims to present the WHO guideline on Biopharmaceutics Classification System-based biowaivers (Annex 7, TRS 1052), emphasizing the main characteristics for the applicability of these biowaivers and establishment of in vivo bioequivalence, while comparing with previous requirements for BCS-based biowaivers. Moreover, the webinar will also present the WHO Biowaiver Project and The WHO Biowaiver List as a Tool to Reach Universal Health Coverage.
Key topics/issues
- Introduction: Briefly introduce the purpose of the webinar and provide an overview.
- The WHO guideline on Biopharmaceutics Classification System-based biowaivers: Present the guideline and discuss the changes compared to the superseded section of the WHO Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability (Annex 6, TRS 1003).
- The WHO Biowaiver Project: Present the multicenter research project established by WHO to experimentally determine the equilibrium solubility profile of medicines listed in the WHO Model List of Essential Medicines using a harmonized approach.
- The WHO Biowaiver List: Present the WHO Biowaiver List: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms (Annex 6, TRS 1052) as a tool for national regulatory authorities and pharmaceutical manufacturing companies, suggesting products that are eligible for a waiver from in vivo bioequivalence studies.
- Q&A session: Allow time for participants to ask questions and provide feedback on the revised guideline.
Same content will be presented during both sessions.
For any issues, please contact kibretb@who.int with a copy to nsp@who.int.