EMA Initiatives for Acceleration of Development Support and Evaluation Procedures for COVID-19 Treatments and Vaccines

On 15 May 2020 the EMA announced the availability of the guidance on how EMA fast-tracks development support and approval of medicines and vaccines against COVID-19.

This document provides an overview of EMA’s rapid formal review procedures related to COVID-19 and is mainly intended as a procedural guide for developers. It complements other documents published under the guidance for medicine developers and companies on COVID-19 and the respective guidance provided for regular procedures published on the EMA website for research and development and for marketing authorisation.

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