{"id":116414,"date":"2022-07-29T10:47:42","date_gmt":"2022-07-29T08:47:42","guid":{"rendered":"https:\/\/www.cde.ual.es\/?p=116414"},"modified":"2022-07-29T10:58:03","modified_gmt":"2022-07-29T08:58:03","slug":"ema-response-to-the-monkeypox-public-health-emergency","status":"publish","type":"post","link":"https:\/\/www.cde.ual.es\/en\/ema-response-to-the-monkeypox-public-health-emergency\/","title":{"rendered":"EMA response to the monkeypox public health emergency"},"content":{"rendered":"

The European Medicines Agency<\/a> (EMA) has initiated a series of actions to respond to the ongoing\u00a0monkeypox\u00a0outbreak, which has been\u00a0escalated by the World Health Organization (WHO) to a Public Health Emergency of International Concern (PHEIC) on Saturday 23 July. This is the first new PHEIC to be declared since the\u00a0regulation reinforcing EMA\u2019s role\u00a0in crisis preparedness and management of\u00a0medicinal products\u00a0and medical devices has become applicable.<\/p>\n

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Since the start of the recent monkeypox outbreak, EMA has been monitoring the situation closely and already taken multiple actions to prepare for and support the EU response. This includes the\u00a0Agency\u2019s recommendation on 22 July\u00a0to approve an extension of\u00a0indication\u00a0for the vaccine\u00a0Imvanex\u00a0to protect adults from\u00a0monkeypox disease. The new powers given to the Agency under its extended mandate trigger additional activities now that monkeypox has been declared a public health emergency.<\/p>\n

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Start of delivery of vaccines in response to the monkeypox outbreak
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Monitoring of supply, demand and shortages of\u00a0medicinal products<\/strong><\/p>\n

The EMA\u00a0Executive Steering Group on Shortages and Safety of Medicinal Products\u00a0(MSSG), established by the new Regulation, will produce and maintain a formal\u00a0list of critical medicines<\/strong>\u00a0for the monkeypox public health emergency. The list will be drawn up in a collaborative process involving Member States, healthcare professionals, patients and consumers.\u00a0<\/u><\/p>\n

Marketing authorisation holders\u00a0of medicines included in the list will be required to regularly update EMA with relevant information on potential or actual shortages and available stocks, forecasts of supply and demand. In addition, Member States will provide regular reports on estimated demand for these medicines at national level.<\/p>\n

This will enable the MSSG to recommend and coordinate appropriate EU-level actions to the European Commission and EU Member States in order to prevent or mitigate potential or actual shortages of critical medicines to safeguard public health.<\/p>\n

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Evolution of monkeypox in Europe
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There are currently\u00a0two\u00a0medicinal products<\/strong>\u00a0authorised specifically for monkeypox in the EU:<\/p>\n