EMA to provide full fee waivers for scientific advice applications from developers of medicines/vaccines against novel COVID-19
The European Medicines Agency (EMA) provides full fee waivers for scientific advice applications from developers of potential therapeutics (to treat the disease) or vaccines (to prevent the disease) against the novel coronavirus disease (COVID-19). 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...