COVID-19

The novel coronavirus (2019-nCoV) is a new strain of coronavirus that had not previously been identified in humans. The coronavirus family is known to cause illness in humans, from common cold to more severe or even fatal diseases such as Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). There are currently no authorised vaccines or treatments in the EU to prevent or treat novel coronavirus disease (COVID-19) specifically or any other coronaviruses.

As a network of the National Competent Authorities (NCAs) in the EU, the HMA are cooperating together with EMA and the European Commission to fight the outbreak of the novel coronavirus disease (COVID-19).

All NCAs support the development and approval of vaccines and treatments for novel coronavirus, together with other regulators in the European Union (EU) and worldwide. The NCAs are also engaged in guaranteeing the availability of medicines products to the patients.
 

HMA/EMA STATEMENT ON APPROVAL OF VACCINES

Development and deployment of safe and effective vaccines is seen as an essential element in the management and solution of the COVID-19 pandemic. In continuation hereof, the European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) have prepare a joint statement on how COVID-19 vaccine applications should be assessed.

Read the joint HMA/EMA statement here or on EMA's website.

EUROPEAN MEDICINES REGULATORY NETWORK COVID-19 BUSINESS CONTINUITY PLAN

The EU network published a plan outlining principles for how the network will ensure that core public and animal health regulatory activities, such as the authorisation, maintenance and supervision of human and veterinary medicines will continue to be carried out during the ongoing COVID-19 pandemic. The business continuity plan for the European medicines regulatory network was lifted in May 2023.

For more information please refer to the joint HMA/EC/EMA press release here or EMA's website.

European medicines regulatory network COVID-19 business continuity plan