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Would it be possible to get an extension for your project due to e.g. changes in regulatory (EMA) guidance, which may cause a delay?

Answer: 

Timely completion of projects is a declared goal under Horizon 2020. There is no flexibility regarding duration – project extensions can generally not be granted in Horizon 2020. Non-compliance with expected timelines and recruitment estimates (significantly delayed key study milestones) might lead to reduced EU contribution or the termination of the grant agreement. Upcoming challenges must be reported quickly and fully to the EC officers in charge. Exceptional project extensions are based on a case-by-case decision by the European Commission.