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.
 

EUROPEAN MEDICINES REGULATORY NETWORK COVID-19 BUSINESS CONTINUITY PLAN

The EU network has 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.

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

 

Clinical trials

HMA, EMA and the European Commission developed a guidance for clinical-trial sponsors on how they should adjust the management of clinical trials and participants during the COVID-19 pandemic which was published on the EMA website.

HMA welcomes the launch of large clinical trials to test promising treatments and to generate conclusive evidence.

Guidance is also available on the actions that sponsors of affected clinical trials should take to help ensure the integrity of their studies and the interpretation of the study results while safeguarding the safety of trial participants as a first priority:

Related HMA contents on clinical trials

Compassionate use

HMA strongly supports compassionate use programmes across Europe when treating COVID-19 patients who are not eligible for inclusion in clinical trials. On 2nd April 2020, EMA’s human medicines committee (CHMP) gave recommendations on how the investigational antiviral medicine remdesivir should be used. These recommendations aimed to ensure a harmonised approach across EU Member States. They also explained which group of patients could benefit from treatment and provide preliminary information on the medicine’s safety.

NB: In July 2020 remdesivir received a conditonal marketing authorisation as the first treatment against COVID-19 in the EU.

 

Related HMA contents on compassionate use

  • Compassionate Use Programmes (from the HMA subgroup on Timely Access)
    The document gives an overview of the situation in the different Member States and makes references to the information published on the websites of the NCAs regarding compassionate use programmes and named patient programmes.

 

EU Executive Steering Group on shortages

Together with the partners in the European medicines regulatory network, such as the European Medicines Agency and the European Commission, HMA has organized the first meeting of the “EU Executive Steering Group on shortages of medicines caused by major events” to discuss measures aimed at addressing the impact of the outbreak of COVID-19 on the supply of medicines in the EU.

Related HMA contents on shortages

 

Procedural guidance during COVID-19 pandemic

The COVID-19 pandemic is having a significant impact on European regulatory activity. The European Commission, the European Medicines Agency and the Heads of Medicines Agencies network (EC, EMA and HMA, respectively) have assessed the situation and agreed on a number of measures to facilitate the management of marketing authorisations for human and veterinary medicinal products considered crucial during the pandemic period.

The European Commission, in collaboration with the network of Agencies, published questions and answers on regulatory expectations for medicinal products for human and veterinary use during the COVID-19 pandemic:

Further guidance, especially on the handling of MR/DC procedures can be found on CMDh and CMDv websites.