DUBLIN – The EMA has activated a COVID-19 task force to coordinate and accelerate the European regulatory response to the pandemic. The task force, which has been established under the authority of the EMA’s human medicines committee (CHMP), is intended to take a lead role in shaping the development, authorization and post-approval surveillance of drugs and vaccines for treating or preventing COVID-19 infection.
It draws on the agency’s core staff and on personnel from the network of national regulators across the European Union. “The COVID-ETF [EMA task force] brings together all relevant expertise available in the network in one group,” an EMA spokeswoman told BioWorld by email. “The members of the group typically lead EMA’s scientific committees or working parties or are members of scientific groups within the EU medicines network. During these extraordinary circumstances, all are part of one group for optimal and fast coordination of activities related to the development, authorization and supervision of medicines and vaccines against COVID-19.”
The task force is chaired by Marco Cavaleri, who is head of biological health threats and vaccines strategy at the EMA and its scientific lead on the COVID-19 pandemic. Cavaleri is also on the scientific advisory board of the World Health Organization’s (WHO’s) R&D Blueprint, which was established in the wake of the West African Ebola epidemic to accelerate the availability of diagnostics, drugs and vaccines during a disease outbreak.
The COVID-19 task force will cooperate with the Clinical Trials Facilitation Group – an existing body that ensures that European members states pursue a harmonized approach to clinical trials – to facilitate clinical trials for promising candidate products. It will also provide another layer of scientific support to existing EMA functional groups.
The role of the task force is proactive rather than reactive. Part of its remit is to review the available data on COVID-19 drugs and vaccines and to identify the most promising candidates. It will also review clinical trial protocols and provide feedback to drug developers when formal scientific advice is not feasible under the compressed timescales that now operate. “They are encouraged to contact EMA by sending an email to 2019-nCoV@ema.europa.eu and discuss their strategy for evidence generation as soon as possible,” the spokeswoman said.
The CHMP retains responsibility for evaluating marketing authorization applications submitted under the EMA’s centralized procedure. National regulators will, as usual, process applications under the decentralized procedure.
The present crisis will be a test of the strength and resilience of Europe’s pooled system for drug regulation, which has already been battered and bruised by the whole Brexit saga. That has weakened the EMA directly – in the sense that it lost significant headcount because of the move from London to Amsterdam – and indirectly through the loss of input from the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), which had long been one of the most effective and prominent members of the EMA’s network.
The COVID-19 pandemic has imposed additional burdens on the agency, due to the surge in clinical development programs trained on the virus and to the logistical difficulties imposed by homeworking for employees of both the EMA and its associated national drug regulators. At the same time, the response to the pandemic is, necessarily, global, and the EMA is part of the International Coalition of Medicines Regulatory Authorities (ICMRA), which earlier today released a report on a virtual workshop, held earlier this month, on regulatory considerations relevant to the development of SARS-CoV-2 therapeutic candidates.
The report, which represents the thinking of 28 regulatory bodies located in 25 countries, as well as the WHO and the European Commission, stated baldly – in contrast to the statements emanating from the White House – that “no specific medicinal product has yet clearly demonstrated efficacy.” It backed the WHO strategy of “multi-arm clinical studies investigating different agents simultaneously” as having “the potential to deliver results as rapidly as possible across a range of therapeutic options.” Workshop participants also agreed that “small studies or compassionate use programs are unlikely to be able to generate the required level of evidence to allow clear-cut recommendations,” but that compassionate use programs do offer a public health benefit and should be allowed to continue, “as long as they do not pose a threat to clinical trials recruitment.”