The Rwanda Food and Drug Authority (Rwanda FDA) has entered a crucial phase of international certification as it hosts World Health Organization (WHO) experts for a comprehensive two-day assessment.
“This is an important milestone in Rwanda’s journey toward global recognition of the Rwanda FDA as a competent authority meeting international standards for healthcare product regulation,” stated Rwanda FDA in an official announcement.
The evaluation, conducted by WHO’s Regulatory System Strengthening team, uses the Global Benchmarking Tool (GBT) to assess the authority’s maturity level. The GBT evaluation examines various aspects of regulatory systems, including registration and approval processes, quality control, surveillance mechanisms, and laboratory testing capabilities.
Achieving Maturity Level 3 certification would position Rwanda FDA among internationally recognized regulatory authorities. This designation indicates that an authority operates at an advanced level of performance and maintains consistent standards in healthcare product regulation.
The assessment follows months of preparation and represents Rwanda’s commitment to strengthening its pharmaceutical and medical product oversight to meet international standards. A successful evaluation would enhance Rwanda’s capacity to participate in global pharmaceutical markets and ensure higher standards of healthcare product regulation.