EMA task force established to co-ordinate rapid regulatory action for COVID-19 medicines

The European Medicines Agency (EMA) has finalised and published the composition and objectives of its COVID-19 EMA pandemic Task Force (COVID-ETF).

The task force was established as part of the agency’s health threat plan, to aid EU member states and the European Commission (EC) in dealing with the development, authorisation and safety monitoring of therapeutics and vaccines intended for treatment or prevention of COVID-19.

According to the EMA, COVID-ETF will enable a fast and coordinated response to the COVID-19 pandemic, by drawing on expertise from the European medicines regulatory network. In all its activities, the task force is accountable to the EMA’s Committee for Medicinal Products for Human Use (CHMP).

The COVID-ETF is chaired by the EMA and composed of the chair and vice-chair of the CHMP, the agency’s safety committee (PRAC), the Paediatric Committee (PDCO) and relevant working parties, as well as the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) and the Clinical Trials Facilitation and Co-ordination Group (CTFG). The agency said it will also include CHMP rapporteurs and co-rapporteurs for all COVID-19 medicines and vaccines, additional experts on an ‘as-needed’ basis and will invite additional observers on a case-by-case basis.

The COVID-ETF’s mandate states it will:

• review the available scientific data on COVID-19 medicinal products and identify promising candidates
• request data from developers and engage with them in preliminary discussions
• offer scientific support in collaboration with the CTFG to facilitate clinical trials conducted in the EU for the most promising COVID-19 medicinal products
• provide feedback on development plans of COVID-19 medicinal products when formal rapid scientific advice is not feasible
• act as advisor to the Scientific Advice Working Party (SAWP) or the CHMP for formal scientific advice and product-related assessment and contribute to the PRAC activities on emerging safety issues related to COVID-19.

The EMA health threats plan describes how the agency and European medicines regulatory network intend to respond to and communicate about serious health threats like the COVID-19 pandemic. The plan is built on experience from the 2009 H1N1 influenza pandemic and other health emergencies since, including the the Ebola outbreak in 2014-2016.

As part of this plan, specific expert groups such as the COVID-ETF and scientific advisory groups can be swiftly convened to assist the EMA’s scientific committees or take part in early scientific discussions and medicines’ reviews.