Background: The COVID-19 pandemic has been highly disruptive in many ways that have exacerbated the ability of regulatory agencies to meet the sudden high demand for approving new medicines and vaccines, ranging from significant disruptions in global supply chains to the switch to remote working in both companies and governments. The net impact was an increased demand for regulatory resources that were already stretched in many places (including the United States). Agencies and companies have responded by increasing reliance on digital technologies and procedures to enable remote communication, collaboration and decision-making. There is opportunity for companies and governments to learn from best practice during the crisis and to implement innovative ways of working to modernize and strengthen regulatory systems in Africa beyond the COVID pandemic. Experience from using new tools such a collaborative registration and reliance on other regulatory agency assessments for decision-making or digital infrastructure such as electronic dossiers, submission portals, and e-signatures can now be embedded into the normal day to day activities to sustainably increase efficiency and speed. This is likewise important for Good Manufacturing Practice inspections.
Overcoming the COVID-19 pandemic in Africa will require delivering significantly more doses to a large percentage of the population, much of which reside in rural or hard to reach areas. Complicating this difficult task, companies are producing new vaccines and treatments every month, as well as developing updated patient guidance and suggested changes in treatments and medicines. All of these issues suggest that it is important for regulatory agencies to have a robust network among themselves, and good collaboration with the African Medicines Agency (as it stands up) and international counterparts. It is equally important for regulators to have good channels of communication with companies to stay on top of the latest developments, and for both sides to learn from each other in preparing new submissions for consideration. The prospect of future disease outbreaks and/or pandemics suggests that these challenges will only become more important.
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