Emerging Health Threats: EMA Releases Response Plans

Regulatory NewsRegulatory News | 17 December 2018 |  By 

The European Medicines Agency (EMA) on Monday released a plan detailing how it would respond to a cross-border emerging health threat.
According to EMA, the plan is based on its 2006 pandemic influenza plan and has been updated based on experience gained during recent disease outbreaks such as the 2009 H1N1 influenza pandemic and the 2014-2016 Ebola virus outbreak.
While EMA says that pandemic influenza and other biological health threats are the “most likely cause of an emerging health threat,” the plan also covers other health threats of chemical, environmental and unknown origins.
Specifically, the 15-page plan details the roles and responsibilities of EMA staff and scientific committees during a health emergency and covers procedural matters to expedite the development and authorization of products to prevent or treat an emerging health threat.
“EMA’s role is to provide the best possible scientific and regulatory advice to support member states in taking the necessary public health decisions,” EMA says.
However, EMA notes that the plan does not cover safety or manufacturing issues for healthcare products, as those issues are covered under the EU Incident Management Plan and handled by the Incident Review Network.
EMA’s main objectives according to the plan are to initiate and coordinate regulatory and scientific activities; manage and coordinate discussions on the development, authorization and surveillance of medicinal products to counter a health threat; and to communicate with the European Commission, other health authorities, healthcare professionals, patients and the public.
The plan also details four levels of activation for EMA depending on the severity of health threat, ranging from Level 1, in which an outbreak has been reported, to Level 4, which would be triggered after the declaration of a public health emergency of international concern (PHEIC) or pandemic with public health in the EU being severely impacted.
Depending on the level of activation, EMA’s response can range from acting as a scientific lead and organizing an ad hoc task force during an emerging threat to deploying strategic and response teams, forming an EMA task force and scientific advisory group and activating a business continuity plan.
The plan also calls for enhanced pharmacovigilance activities during a health threat. Such measures include faster signal management, allocating additional resources to tracking emerging safety issues and rapid exchange of information between EMA, member states and the European Commission on pharmacovigilance issues.
Statement, EMA Plan for Emerging Health Threats


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