WHO opened draft QAS/25.990 for public consultation. It was posted on April 24, 2026. ECA reported the update on May 28, 2026. Comments remain open until June 23, 2026. The revision could reshape evidence for immediate-release generic medicines.
WHO Revising Bioequivalence Requirements
WHO is revising bioequivalence expectations for immediate-release tablets, capsules, and oral suspensions. Draft QAS/25.990 aligns with ICH M9, ICH M10, and ICH M13 while addressing dose proportionality, endogenous compounds, pH effects, and special product categories. The problem is inconsistency between global requirements, which can complicate study design, analytical validation, regulatory submissions, and generic-drug interchangeability decisions across multiple markets for sponsors.
Bioequivalence Alignment Creates Risks and Opportunities
Unclear bioequivalence requirements can produce failed studies, delayed generic approvals, repeated HPLC analysis, and avoidable costs for sponsors. WHO alignment with ICH M9, ICH M10, and ICH M13 creates a positive opportunity for more consistent protocols, validated bioanalytical methods, and stronger regulatory submissions. However, companies may need to revise SOPs, statistical plans, comparator selection, and data-integrity controls before the June deadline or future implementation exposes unresolved evidence gaps during inspections.
Why WHO, HPLC, and ICH Matter to Pharma Professionals
This WHO consultation matters to regulatory affairs, bioanalytical laboratories, and generic-drug development teams. Each group must assess how revised bioequivalence expectations affect study protocols, HPLC methods, data integrity, statistics, and submission strategy before comments close and requirements influence development programs.
Regulatory Affairs Professionals
Regulatory affairs professionals must compare WHO’s draft with current regional requirements. Misaligned protocols or incomplete justifications can trigger questions, repeat studies, delayed approvals, and inconsistent generic-drug submissions across international markets.
- Compare draft requirements with regional guidance.
- Submit evidence-based comments before June 23.
Bioanalytical Laboratory Teams
Bioanalytical laboratory teams must verify HPLC methods, calibration models, sample stability, audit trails, and reintegration controls. Weak data integrity can invalidate pharmacokinetic evidence and undermine defensible bioequivalence conclusions during reviews.
- Verify validated HPLC method performance.
- Review audit trails and reintegration controls.
Generic-Drug Development Teams
Generic-drug development teams must connect formulation choices, dissolution behavior, comparator selection, and study design. Poor alignment can increase development costs, repeat testing, and delays before affordable medicines reach patients globally.
- Assess comparator products before study design.
- Align dissolution evidence with formulation risks.
What Could Stronger Global Alignment Achieve?
WHO’s QAS/25.990 consultation closes June 23, 2026, giving stakeholders a defined opportunity to identify practical gaps. Strong feedback may support clearer global expectations, better study quality, and more reliable generic-drug decisions. Sponsors should review protocols, bioanalytical methods, SOPs, and data controls now, then submit evidence-based comments before the formal deadline.
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