African Medicines Regulatory Harmonisation (AMRH) Strengthens Continental Systems

The African Medicines Regulatory Harmonisation (AMRH) initiative, led by AUDA-NEPAD, continues to strengthen regulatory systems across the African continent. The program addresses critical challenges in pharmaceutical regulation including weak legislative frameworks, redundant processes, and limited technical capacity.

The work of AMRH is guided by three focus areas:

1. Policy Alignment and Coherence - Harmonising regulatory policies and frameworks across African countries to reduce fragmentation and improve efficiency.

2. Regulatory Systems Strengthening - Building capacity of National Regulatory Authorities (NRAs) through training, technical support, and infrastructure development.

3. Pharmacovigilance and Post-Market Surveillance - Establishing robust systems for monitoring medicine safety, adverse event reporting, and signal detection across the continent.

Key AMRH Achievements:

• Establishment of Regional Centres of Regulatory Excellence (RCOREs)
• Development of harmonised guidelines and standards
• Implementation of joint assessments and inspections
• Capacity building programs for regulatory professionals
• Support for mutual recognition agreements among African countries
• Integration with the African Medicines Agency (AMA) framework

The AMRH program collaborates with National Regulatory Agencies (NRAs), Regional Economic Communities (RECs), the African Union Commission (AUC), Pan African Parliament (PAP), the World Health Organization (WHO), the Bill and Melinda Gates Foundation, and other partners to achieve its objectives.

Through these efforts, AMRH is working to ensure that African populations have access to quality-assured, safe, and efficacious medicines while supporting the continent's pharmaceutical manufacturing capacity and regulatory independence.