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Crisis Management

Standard Operating Procedure for Crisis Management

April 24, 2019

Health crises are generally poorly predictable, multifaceted and involve multiple stakeholders, and they often become political priorities.

Health regulatory authorities for medical products play a significant role in preventing and responding to global health crises, as health product-related activities are critical to the management of the crisis. As the role of Health Regulatory Authorities in global crises is not always understood by the public, it is necessary to clarify how they agree and engage in coordinated responses and communication at international level.

Although there are several initiatives dealing with global health crises at international level, until now there was no explicit specific mechanism for Health Regulatory Authorities to manage crises. As a response, a framework has been developed by ICMRA.

This framework explains the involvement of Health Regulatory Authorities and addresses their roles and responsibilities in such crises, it also identifies opportunities for deeper international collaboration. It establishes as well a Standard Operating Procedure (SOP) addressing structured communication between focal points, a platform for information exchange, and defines the pivotal role of ICMRA secretariat in organisational support.