Europe – Guidance for medicine developers and companies on COVID-19

The European Medicines Agency (EMA) is providing guidance for medicine developers and pharmaceutical companies to help speed up medicine and vaccine development and approval for COVID-19, and on how they should address the regulatory challenges arising from the COVID-19 pandemic.

EMA encourages developers of potential vaccines or treatments for COVID-19 to contact EMA as soon as possible to discuss their strategy for evidence-generation.

They should email their proposals to 2019-ncov@ema.europa.eu.

Depending on the maturity of development, EMA will set up initial discussions on suitable mechanisms to fast-track development and approval, with priority given to the most relevant proposals.

Establishing contact early in the development process is important for ensuring that developers can submit well-prepared applications and make use of the accelerated procedures EMA has put in place for COVID-19 treatments and vaccines…