The European Medicines Agency, the EU agency in charge of the evaluation and supervision of medicinal products, has – unsurprisingly – been rather busy with the current health crisis. Commission en direct takes a look at two of its recent initiatives: free scientific advice for developers of a vaccine or treatment against COVID-19, and ensuring a steady supply of all medicines in the current context.
To help the fight against the novel coronavirus, EMA announced at the end of last week that it "will provide 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."
In practice, this means that scientists working on a vaccine or treatment against the disease can contact the agency with detailed information about their research. In the first round of discussions, EMA will provide preliminary informal comments and feedback on the development. This will then allow the Agency to identify the products that are mature enough to benefit from fast-track scientific advice, and give 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.