INTERNATIONAL CO UNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED GUIDELINE BIOEQUIVALENCE FOR IMMEDIATE - RELEASE SOLID ORAL DOSAGE FORMS A DDITIONAL STRENGTHS B IOWAIVER M13 B Draft version Endorsed on 13 March 2025 Currently under public consultation At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Assembly to the regulatory authorities of the ICH regions for internal and external consultation, according to national or regional procedures.