EMA stands up task force to oversee regulatory response to COVID-19

Regulatory NewsRegulatory News | 09 April 2020 |  By 

The European Medicines Agency (EMA) on Thursday stood up a new task force to coordinate the development and oversight of drugs and vaccines used to treat or prevent coronavirus disease (COVID-19).
Specifically, the task force, dubbed COVID-ETF, will be charged with reviewing scientific data for products in development for COVID-19 and to request data from developers with the aim of identifying promising candidates against the virus.
The task force will also provide scientific support for clinical trials of promising candidates in the EU and feedback on medicinal product development to sponsors when formal rapid scientific advice is infeasible.
The creation of the new task force is part of the agency’s emerging health threat plan released in 2018, which itself was developed based on the agency’s 2006 pandemic influenza plan and built on experience gained through the 2009 N1N1 influenza pandemic and the 2014-2016 Ebola virus outbreak in West Africa.
EMA says the task force is necessary to address the unprecedented challenges posed by the COVID-19 pandemic.
“Such challenges are represented particularly by the complexity of the disease, of which much is yet to be understood, the consequent plethora of potential or repurposed medicinal products for prophylaxis or treatment, and the need to conduct and coordinate clinical trials in a timely manner across Europe,” EMA writes.
The task force will report the EMA’s Committee for Medicinal Products for Human Use and will include representatives from EMA, CHMP, and other EMA committees and working groups, such as the Pharmacovigilance Risk Assessment Committee and Pediatric Committee. The task force will also include the rapporteurs assigned to products intended for COVID-19 and members of the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) and the Clinical Trials Facilitation Group (CTFG).
In a document explaining the task force’s mandate, rules and procedures, EMA also takes pains to guarantee the independence of the task force members. Specifically, EMA that COVID-ETF members and experts “shall not have any direct interests in the pharmaceutical industry, which could affect their impartiality.”


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