EFPIA welcomes the peer-reviewed publication of the research-based industry experience of COVID-19 regulatory flexibilities in Europe
10.02.22
EFPIA welcomes the publication of a landmark study [1] that captured the experience and impact of regulatory flexibilities provided by Regulators across Europe during the COVID-19 pandemic. Flexibilities were recorded by the research-based industry and captured and assessed by the independent study team, EXON Consultancy [2]. This evidence will serve to inform planning for future pandemic preparedness and also provides essential guidance on where we can focus our efforts to further advance the European regulatory environment for all products and settings.
The study records that the regulatory flexibilities provided successfully served to address critical needs for clinical research, licensing, manufacturing and supply during the pandemic. There were important differences identified and captured as ‘lessons learned’ for future pandemics. Moreover, the findings also indicate that many flexibilities are foreseen to have value beyond the pandemic, particularly where the EU/EEA and its Member States collaborate and align to deliver a single, streamlined regulatory framework. The research identified some clear drivers for this impact: digitalisation and innovations in the regulatory science process, such as rolling reviews and flexible Scientific Advice.
Looking beyond the study itself, Isabelle Stoeckert, VP Regulatory Affairs EMEA, Bayer AG, Chair of the EFPIA COVID-19 Rapid Response Team and one of the study’s authors, said, “This peer-reviewed study provides one of the first shared, evidence-based reviews of the regulatory flexibilities provided in the EU and how these flexibilities addressed the need to sustain clinical research, manufacturing, and licensure during the COVID-19 pandemic. What we have illustrated, though, is the value of some of these flexibilities beyond a pandemic setting. We believe that these findings should inspire us to go further in Europe. EFPIA believes that the most impactful flexibilities signal where we need to go further to deliver a step change in faster, more equitable access to medicines for patients and ensure that Europe can be at the forefront of the development of the next generation of diagnostics, treatments and vaccines.”
[1] Klein, K., Stolk, P., Tellner, P. et al. Regulatory Flexibilities and Guidances for Addressing the Challenges of COVID-19 in the EU: What Can We Learn from Company Experiences?. Ther Innov Regul Sci (2022). https://doi.org/10.1007/s43441-022-00383-3