news

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

7
SHARES

The COVID-19 EMA pandemic Task Force (COVID-ETF) will aid in the development, authorisation and safety monitoring of COVID-19 vaccines and therapeutics.

European Union flag (blue with circle of gold stars) with a blood vial on top labelled 'Coronavirus test, positive'

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

 

ACCESS your FREE COPY

 


This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.

Access the full report now to discover the techniques, tools and innovations that are transforming pharmaceutical formulation, and learn how to position your organisation for long-term success.

What you’ll discover:

  • Key trends shaping the pharmaceutical formulation sector
  • Innovations leading progress in pharmaceutical formulation and how senior professionals can harness their benefits
  • Considerations and best practices when utilising QbD during formulation of oral solid dosage forms
  • And more!

Don’t miss your chance to access this exclusive report ! Access now – it’s free

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.

Share via
Share via