Since the beginning of the COVID-19 pandemic the regulatory affairs framework has faced one of the biggest challenges in its history. The need to get an effective and safe vaccine as soon as possible has pushed Health Authorities (HAs) to go beyond the usual approval timeframe, while urging them to adopt a work-sharing approach on a global scale. Consequently, this scenario has triggered a rapid regulatory evolution of some initiatives which have been previously launched, however, in this light they are becoming more and more vital to address the urgent need for specific medical products.
As a result, in the last few years two projects called Orbis and Access Consortium have been launched under the coordination of two major Regulatory Agencies, the US FDA and the UK MHRA, and they could increasingly become a consolidated approach into the regulatory affairs workspace.