Regulatory Flexibilities and Guidances for Addressing the Challenges of COVID-19 in the EU: What Can We Learn from Company Experiences?

ABSTRACT

The COVID-19 pandemic required urgency in the development and delivery of effective vaccines and therapeutics; meanwhile, ongoing clinical research, regulation and supply for other much-needed therapeutics and vaccines needed to be sustained. In Europe, the European Commission, the European Medicines Agency (EMA) and the national regulatory agencies (NRAs) responded by issuing guidance outlining regulatory flexibilities mainly directed at COVID-19 vaccines and, belatedly, therapeutics. Using a survey methodology, this study gathered the views of the R&D based pharmaceutical industry in May-June 2021 on the value of these flexibilities for continued use in the post-pandemic era as well as for future use in health emergency situations. Findings indicate that many flexibilities were foreseen to have value beyond the pandemic, particularly where EU and Member States aligned closely to provide a singular, streamlined regulatory environment. Digitalization was a notable driver of these flexibilities, but innovations in regulatory process (e.g. rolling reviews, flexible Scientific Advice) improved the process and outcomes measurably. Finally, the rapid reaction of the EU regulatory system and extensive efforts by all involved in providing innovative therapeutics and vaccines to patients in need provides learnings for the upcoming overhaul of the pharmaceutical acquis.