Regulatory Systems Strengthening for Medicines in Africa
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Washington, DC
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The African Medicines Regulatory
Harmonization (AMRH) initiative, a multistakeholder
partnership, focuses on improving fragmented regulatory
systems in the region to ensure faster access to safe,
efficacious, and good quality medicines and vaccines. With
support from the Bill and Melinda Gates Foundation, the
World Bank Group set up a trust fund in 2011 to support AMRH
work. Since then, significant improvements have been made
across the region, including notable decreases in timelines
for the registration of medicines, more harmonized
registration systems, and an enhanced focus on quality
management and transparency in the drug registration
process. The Coronavirus (COVID-19) pandemic has shown that
harmonized and well-established regulatory systems are
critical to ensure access to safe, efficacious, and good
quality medicines and vaccines. The establishment of the
African Medicines Agency, the next chapter in the AMRH
initiative, provides the opportunity to continue
institutionalizing this important medicine regulatory
system’s strengthening work, while increasing country
ownership and ensuring sustainability.
Palabras clave
AFRICAN MEDICINES REGULATORY HARMONIZATION (AMRH) INITIATIVE, ACCESS TO MEDICINES, ACCESS TO VACCINATION, REGISTRATION OF MEDICINE TIMELINE, HEALTHCARE REFORM, AFRICAN MEDICINES AGENCY, MEDICINE REGULATORY SYSTEM REFORM, HEALTH SYSTEMS, HNP KNOWLEDGE BRIEF