20 Apr 2020
Posted in Pharma
EMA task force to expedite and coordinate regulatory actions for COVID-19 treatments
Regulatory bodies worldwide are taking action to combat COVID-19. In Europe, the European Medicines Agency (EMA) has established the COVID-19 EMA pandemic Task Force (COVID-ETF), which will work with the Member States and the European Commission (EC) on therapeutics and vaccines for the virus. Past examples of such task forces in the fight of Swine Flu helped support the quick production of a vaccine in the past, suggesting that COVID-ETF will be a positive step in this pandemic’s timeline.
Johanna Swanson, Product Manager at GlobalData comments: “This task force joins the growing list of regulatory bodies responding to the threats in a rapid and coordinated manner. These include the FDA’s Coronavirus Treatment Acceleration Program (CTAP) to speed up COVID-19 treatments in the US. These groups must work to facilitate identification and development of treatments, improve communication, engage diverse stakeholders, evaluate risks and improve compliance during this health crisis to get treatments out in a meaningful timeframe.
“In the past H1N1 epidemic, the EMA helped facilitate the rapid authorization of five pandemic vaccines within five months of the identification of the novel virus by the continued commitment of resources to the pandemic. It also authorized two antiviral medications for compassionate use: Tamiflu and Relenza. These examples show that these types of task forces work well to support vaccine development, providing some hope that this is a positive step towards a COVID-19 vaccine.”
The COVID-ETF’s purpose is to use the European medicines regulatory network to ensure that the response to the COVID-19 pandemic is both fast and coordinated among stakeholders. The EMA’s Committee for Medicinal Products for Human Use (CHMP) will hold the task force accountable and impose strict rules to maintain the independence of all members.
The functions of the COVID-ETF will be multitude. It will identify COVID-19 treatment candidates by reviewing scientific data and will work with developers to obtain and discuss the data. It will facilitate EU clinical trials for COVID-19 and offer support and collaboration with the Clinical Trials Facilitation and Coordination Group (CTFG). In addition, the task force will provide rapid scientific advice on COVID-19 treatment development plans and emerging safety issues. It will also work on ensuring the engagement and cooperation of all relevant European and international organization’s stakeholders.
The EMA has developed a health threat plan to describe how it will plan for and respond to serious health threats in conjunction with the European medicines regulatory network. It continues its work from the 2009 H1N1 pandemic and the 2014–2016 Western Africa Ebola outbreaks. This plan will help the swift convening of the EMA’s task force and advisory groups for scientific committees.