Easing the regulatory burden

Various regulatory agencies, such as the European Commission, the EMA, and national Head of Medicines Agencies (HMA) have all published new recommendations on how to manage clinical trials in the wake of the coronavirus disease (COVID-19) pandemic.

To accelerate the development of COVID-19 treatments and vaccines in general, institutional review boards (IRBs) ethics committees (ECs) and regulatory authorities (RAs) are expediting timelines. Where ICON has encountered countries that have not implemented expedited review times, we have reached out directly to ensure this is implemented. Specifically, this was performed recently in The Netherlands, where upon discussion with ICON, they agreed to reduce the review time to 24 hours.

While regulatory and industry focus will always be on maintaining patient safety, a certain easement of the regulatory burden is being introduced. With the caveat that ensuring patient safety is foremost and that all changes must be documented, and all risks assessed, regulators aim to allow:

• Accelerated clinical trial start up
• Compassionate use
• Accelerated agency and ethics approval timelines
• Less stringent reporting requirements, product import rules, and patient supply measures

Furthermore, in the United States, groups such as The Coalition for Epidemic Preparedness Innovations (CEPI) and Biomedical Advanced Research and Development Authority (BARDA) have enabled key assets and infrastructures to be leveraged in response to this pandemic. The first global regulatory workshop on COVID-19 was convened on March 18th under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). The virtual meeting brought together delegates from 17 different countries, representing more than 20 medicines regulatory authorities globally, as well as experts from the World Health Organization and the European Commission, to discuss the development of vaccines against COVID-19. The event was co-chaired by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).