The establishment of the African Medicines Agency in November 2021 is an important opportunity for Africa to leapfrog other regions and become one of the most efficient and modern regulatory systems in the world. This opportunity can rapidly transform into reality, by using the experience gained from a decade of harmonization activities in the continent, learnings gained during the pandemic and the swift implementation of modern and innovative solutions.
Covid lockdowns have shown the clear need for regulators to continue their critical business activities in a virtual environment. While some Regulatory Agencies are frontrunners in digitalization, many Regulatory agencies in Africa have not yet moved into the digital era. Those agencies were facing serious business disruptions that had a very negative impact on public health during the Pandemic.
Digitalization is essential to supporting communication and business operations within regulatory Agencies in Africa. A connected digital infrastructure that enables secure communication between regulators, as well as between the private sector and regulators, would be one of the major enablers to strengthen public and private collaboration. Leveraging digital innovations also supports the linkages among the continental, regional and local regulatory systems and facilitates work sharing and reliance among peers.
The implementation of electronic submission systems according to ICH standards (M8 electronic technical document) is already underway in some regional economies. ECTD is already used in many jurisdictions instead of paper dossier submissions. This has contributed to the improvement of the environmental footprint and is saving resources. However, significant technical, operational, and funding challenges still need to be overcome to ensure a swift and seamless implementation of these new systems. Close collaboration with Industry stakeholders is critical to ensure a smooth digital transition while avoiding disruption of medicine supply.The private sector is ready to provide its full support and to collaborate with Health Authorities in the shaping of the regulatory environment and to drive the changes in legislation necessary to support Electronic Platforms and Infrastructure,eCTD, electronic dossiers, e-laws, e-Documents and e-Signatures implementation.
This webinar will bring together a panel of key U.S. and African government officials and business leaders to highlight strategies that leverage digital innovations to improve regulatory systems and strengthen health security in Africa. This session is presented by CCA's U.S.- Africa Health Security and Resilience Initiative (HSRI). HSRI brings together major U.S. and African leaders, corporations, multilateral organizations, foundations, and other health sector stakeholders to collaborate on developing policies, promoting strategic partnerships, providing critical Africa health-related information, and facilitating investment to strengthen Africa's health systems security and resilience.