Regulatory flexibilities and guidance for addressing the challenges of COVID-19 in the EU

During the COVID-19 pandemic, EU regulators introduced flexibilities to assure the continuity of activities so that scientific progress is not impeded, and to assure the continuity of access to much-needed vaccines and treatments for patients. In 2022, Exon Consultancy assessed the value and future applications of the regulatory flexibilities introduced during the COVID-19 pandemic.

We designed and distributed a survey among 57 R&D based pharmaceutical companies, including EFPIA member companies, small and medium-sized enterprises (SMEs) and EFPIA partners in research, to gather their views on the value of these flexibilities for continued use in the post-pandemic era as well as for future use in health emergency situations. Our findings have been published in a peer-reviewed scientific journal, which aims to contribute to policy discussions for improving the efficiency of the EU regulatory system, and to strengthen the pandemic preparedness in the EU.

More information about the project can be found here.

Client:
EFPIA

Date of completion:
2022