Regulatory Harmonization & Excellence

Regulatory Harmonization

The development of clinical trials in Africa depends on harmonized standards and scientific collaboration.

Harmonization does not mean lowering standards — rather, it means building a shared, science-based, and
internationally accepted framework that allows for faster, better-informed decisions.

AVAREF works with continental and international experts to develop:

  • Templates and standardized forms
  • Guidelines and guidance documents
  • Technical recommendations and benefit-risk assessment reports

These resources help countries align their systems while maintaining scientific rigor.

Access the full AVAREF Guidelines and Tools Library.

Knowledge Transfer

Knowledge sharing plays a central role in achieving regulatory excellence.
AVAREF regularly organizes webinars, technical exchanges, and virtual discussions
on current topics in clinical research, pharmaceutical regulation, and research and development.

These sessions promote peer learning, foster collaboration, and help strengthen the capacity
of regulators, ethics committees, and research institutions across Africa.

🎓 Explore our learning resources:

Digital Platform

AVAREF is developing a digital platform to enhance coordination, data access, and information sharing across countries.

This platform will serve as a secure, collaborative workspace where regulators and ethics experts can jointly review clinical trial applications and exchange technical insights in real time.

Key features include:

  • Simultaneous access to dossiers and supporting information for all authorized reviewers.
  • Collaborative review tools to enable multi-country evaluation and expert discussion.
  • Interactive dashboards for tracking review progress, timelines, and outcomes.

The platform will help streamline the review process, promote transparency, and strengthen harmonization of regulatory decisions across Africa.