• National ethics SOP package completed and aligned with Law 015/2022 and Ministerial Order 002/2023.
• SOPs harmonized with AVAREF standards, WHO guidelines, and ICH-GCP.
• Integrated checklists, templates, decision letters, and review tools across all RNEC workstreams.
• Full legal cross-mapping completed to streamline RNEC operations and IRB reporting obligations.

• Digital platform gap analysis, user requirements, and technical specifications completed (URS & TS).
• RNEC–Rwanda FDA interoperability pathway drafted, including workflow linkages and data-exchange points with IRIMS.
• Technical specifications validated with cybersecurity, data privacy, and DPP Law compliance requirements.
• National architecture anchored in a unified ethics–regulatory digital ecosystem.

• National training matrix developed with 15 targeted modules, including AVAREF assessor training, GCP, biomedical ethics, pharmacovigilance, IRB accreditation, reliance, and digital/AI ethics.
• Curriculum co-designed with the MRCT Center; aligned with WHO Academy, AVAREF, and ICH guidelines.
• Capacity development plan tied to WHO Ethics Benchmarking indicators.

• Initial cost-recovery model and fee structure drafted to support long-term RNEC sustainability.
• Rwanda FDA and RNEC collaborating on integration of review fees into the future digital platform.
• Financial data consolidation ongoing to finalize the national sustainability workbook.

Based on the WHO Ethics Benchmarking Tool (EBT) assessment, Rwanda:

• Scored strongly in Legal Provisions and RNEC Procedures.
• Partially met indicators identified in:
  • Government support to RECs,
  • Resources & infrastructure,
  • Transparency (public posting of procedures, funding sources),
  • Complaint mechanisms,
  • Monitoring and performance audits

As a result, a national action plan was developed to address the nine identified gaps and implement improvements through TRACE activities.