Overview of coronavirus (COVID-19) review procedures for treatments published

Overview of coronavirus (COVID-19) review procedures for treatments published

The European Medicines Agency (EMA) has published an overview of its rapid formal review procedures related to coronavirus (COVID-19) vaccines and treatments. The procedures addressed in the document are rapid scientific advice, rapid agreement of a paediatric investigation plan and rapid compliance check, rolling review, marketing authorisation, extension of indication and extension of marketing authorisation, compassionate use and other considerations that may arise. The document, which is intended mainly as a procedural guide for developments, complements other documents published under the guidance for medicine developers and companies on coronavirus and the respective guidance provided for regular procedures published on the EMA website for research and development and for marketing authorisation.

The guidance for medicine developers in relation to coronavirus is available here.

The guidance for research and development can be accessed here and for marketing authorisations is available here.

Source: EMA initiatives for acceleration of development support and evaluation procedures for COVID-19 treatments and vaccines

Related Articles:
Latest Articles: