Biowaivers WHO perspectives 

• In: Regulatory harmonisation: Successes and challenges along the pathway to regulatory convergence on Tuesday, 2 September 2025, 11:00-12:30
• At: Copenhagen (Denmark) (2025)
• Type: Presentation
• By: GWAZA, Luther
• Abstract:

  Biowaivers play a critical role in accelerating access to quality-assured medicines by reducing the need for in vivo bioequivalence studies when scientifically justified. The World Health Organization (WHO) has issued guidelines on both Biopharmaceutics Classification System (BCS)-based biowaivers and biowaivers for additional strengths, in line..

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