Developers of potential therapeutics or vaccines against COVID-19 are invited to contact the Agency as soon as possible with information about their proposed development, by emailing
2019-ncov@ema.europa.eu. In a first round of discussions, EMA can provide preliminary informal comments and feedback on the development. This will then allow the Agency to identify the products which are mature enough to benefit from fast-track scientific advice, to guarantee best use of this tool.
In the context of the COVID-19 pandemic, with this fast-track scientific advice, the Agency can give developers prompt guidance and direction on the best methods and study designs to generate robust information on how well a medicine or vaccine works and how safe it is.
Since the beginning of the outbreak, the Agency has organised teleconferences with several developers of potential medicines and vaccines against COVID-19. Member States are kept updated on these activities. EMA is also working closely with international regulatory authorities.
EMA is actively supporting the World Health Organization’s (WHO) activities on the prioritisation and analysis of available evidence. Most potential therapeutics initially identified in this context are repurposed agents (i.e. medicinal products already authorised for another purpose) or investigational agents that are or will be investigated for treatment and in some cases for prophylaxis against the disease. EMA’s priority is to accelerate the approval of safe and effective therapeutic candidates to treat people infected by the virus as soon as possible.
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