Enhanced Role of EMA in EU Crisis Response

ABSTRACT

The regulation also sets out obligations on marketing authorization holders (MAHs) and medical devices manufacturers, authorized representatives, importers, distributors, and notified bodies duties to * Provide information that will assist with the monitoring by the MSSG/MDSSG of shortages of medicinal products and devices contained in the critical medicines list and updating this when necessary * Provide a justification for any failure to provide the requested information by the established deadlines * Immediately provide any evidence of an actual or potential shortage of medicinal products or devices * Provide information to EMA by 2 Sep. 2022 that will enable the establishment of a Single Point of Contact (SPOC) network, and the industry Single Point of Contact (iSPOC) network, with mandates to updating this when necessary (7). Enhanced advisory role In addition to the measures designed to address medicinal and medical device shortages, an Emergency Task Force (ETF) will also be established within EMA to provide scientific advice and review evidence on medicines that have the potential to address public health emergencies, offer scientific support to facilitate clinical trials, and support existing EMA committees with their authorization and safety monitoring of medicines (8). According to the document published by EMA on Crisis Preparedness and Management, the key benefits for EMA of having these responsibilities include * Accelerated evaluation and access to safe and effective medicines which could treat or prevent a disease causing, or likely to cause, a public health emergency * Improved quality of data and the effective use of resources through increased support at EU level towards the conducting of clinical trials in preparation for, and during a public health emergency * Improved coordination and harmonization at EU level in preparation for and during a public health emergency (7).