CMC Strategy Forum Latin America 2021

The ongoing COVID-19 pandemic poses challenges to all National Regulatory Authorities (NRAs) and industry in the short, medium and long term. In LATAM, where there are differing capacities, resources and infrastructure across NRAs, several potential challenges and issues impact regulatory processes in different levels. Many solutions were already applied by some NRAs to minimize the pandemic impacts, avoid shortages and maintain business continuity, as the use of expedited pathways, reliance procedures, local quality control exemption for imported products and different digital solutions, such as virtual meetings, virtual inspections, e-CPP, e-GMP, e-labeling and electronic submissions. Some important lessons can be taken by this unprecedented situation, which may provide an opportunity for Regulators and Industry to strengthen their regulatory systems and implement the Best Regulatory Practices in a long term.