EMA strengthens ENCePP mandate to address COVID-19 pandemic
Regulatory News | 26 May 2020 |
The European Medicines Agency (EMA) has strengthened the mandate for the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), creating a COVID-19 Response Group working within ENCePP to aid in pharmacovigilance and pharmacoepidemiology work amid the pandemic.
EMA said the new mandate is necessary to address “unprecedented challenges for the epidemiological and regulatory communities” in addressing COVID-19. “This role would give ENCePP centres high visibility and recognition as key players in the fight against COVID-19 and for public health protection,” the agency said.
The current overarching mandate of ENCePP is to strengthen how the risks and benefits of medicinal products in Europe are monitored. Specifically, ENCePP achieves this by facilitating high quality, multi-center post-authorization studies (PAS) that are conducted independently, with a focus on observational research.
The mandate will be expanded during the pandemic to “facilitate access to high quality data and their analysis to support research and regulatory decisions in relation to the COVID-19 pandemic,” EMA said.
An existing ENCePP mandate to support and provide a platform for pharmacovigilance and pharmacoepidemiology will be augmented by more support for collaborations that focus on high quality multi-center observational research, as laid out in a recent International Coalition of Medicines Regulatory Authorities (ICMRA) workshop. (RELATED: Multinational efforts build framework for real-world and observational COVID-19 data, Regulatory Focus 21 May 2020).
Finally, ENCePP will promote the “use and dissemination of valid and reliable methodologies appropriate to COVID-19,” thereby improving regulatory science. This new mandate augments existing mandates to develop and maintain standards for methodology and principles of research governance in pharmacovigilance and pharmacoepidemiology.
The new COVID-19-related ENCePP mandate’s implementation will be guided by both the ENCePP steering group and the EMA, with the formation of a new ENCePP COVID-19 Response Group. This group will guide implementation of priorities it identifies in data access, collaboration, funding and methodologic work. The ENCePP steering group will meet at least quarterly to review the Response Group’s work, according to the new framework.
Specific examples of issues that the Response Group may address include review of COVID-19 study protocols; publication of a review article summarizing observation research from the European Union PAS register that identifies research gaps and priorities and outlines study designs; consideration for centralizing a list of data sources held by EU member nations; and providing guidance for pharmacoepidemiologic studies of treatments and vaccines for COVID-19.
EMA said the new mandate is necessary to address “unprecedented challenges for the epidemiological and regulatory communities” in addressing COVID-19. “This role would give ENCePP centres high visibility and recognition as key players in the fight against COVID-19 and for public health protection,” the agency said.
The current overarching mandate of ENCePP is to strengthen how the risks and benefits of medicinal products in Europe are monitored. Specifically, ENCePP achieves this by facilitating high quality, multi-center post-authorization studies (PAS) that are conducted independently, with a focus on observational research.
The mandate will be expanded during the pandemic to “facilitate access to high quality data and their analysis to support research and regulatory decisions in relation to the COVID-19 pandemic,” EMA said.
An existing ENCePP mandate to support and provide a platform for pharmacovigilance and pharmacoepidemiology will be augmented by more support for collaborations that focus on high quality multi-center observational research, as laid out in a recent International Coalition of Medicines Regulatory Authorities (ICMRA) workshop. (RELATED: Multinational efforts build framework for real-world and observational COVID-19 data, Regulatory Focus 21 May 2020).
Finally, ENCePP will promote the “use and dissemination of valid and reliable methodologies appropriate to COVID-19,” thereby improving regulatory science. This new mandate augments existing mandates to develop and maintain standards for methodology and principles of research governance in pharmacovigilance and pharmacoepidemiology.
The new COVID-19-related ENCePP mandate’s implementation will be guided by both the ENCePP steering group and the EMA, with the formation of a new ENCePP COVID-19 Response Group. This group will guide implementation of priorities it identifies in data access, collaboration, funding and methodologic work. The ENCePP steering group will meet at least quarterly to review the Response Group’s work, according to the new framework.
Specific examples of issues that the Response Group may address include review of COVID-19 study protocols; publication of a review article summarizing observation research from the European Union PAS register that identifies research gaps and priorities and outlines study designs; consideration for centralizing a list of data sources held by EU member nations; and providing guidance for pharmacoepidemiologic studies of treatments and vaccines for COVID-19.
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