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

SUBMITTER: Klein K 

PROVIDER: S-EPMC8821789 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature