Regulatory agilities in the time of COVID-19: Overview, Trends and Opportunities

Abstract Purpose Critical steps have been adopted by health and regulatory authorities around the world to respond to the COVID-19 pandemic. The authors aim to highlight these by providing an overview of the regulatory approaches adopted during the onset of the pandemic, provide an assessment of observed trends, and offer some reflections and proposals to leverage learnings and opportunities from this current pandemic. Methods The authors collected and classified documents and informational materials relating to the regulatory environment around the development and management of medical products during the COVID-19 pandemic. These have been sourced from official websites and press releases of health authorities and international bodies from selected markets across the globe and covers the period between January to July 2020. Additional information to support this study has been gathered through a literature review and analysis of related data available in the public domain and complemented with our own experience in the company. Findings Communication has been vital in addressing the impact of COVID-19. More than 1700 documents and informational materials have been gathered relating to health or regulatory response to the COVID-19 pandemic. Out of these 1705 documents, around 20% or 343 have been identified as regulatory agilities. These agile approaches have been classified into three major categories namely where health and regulatory authorities have: a) facilitated product management across the entire lifecycle, notably in expediting medical product use, ensuring the continuity of clinical trials, and addressing supply chain issues; b) strengthened international cooperation; and c) addressed regulatory burden with the adoption of electronic and digital tools. Implications While many of these regulatory measures have been introduced temporarily as a response to the COVID-19 crisis, there are opportunities to leverage learnings from these approaches in order to collectively achieve more efficient regulatory systems to mitigate and address the impact of the COVID-19 crisis and further future-proof the regulatory environment.