Patient and doctor in discussion with a clipboard in a consultation room

The Clinical Trials Regulation will not be applied, and the Clinical Trial Directive will not be repealed, until full functionality of the Clinical Trial Information System (CTIS or “Portal”) has been confirmed by independent audit.  This is now due to be conducted in December 2020.

More information can be found on the EMA website:

For guidance on Clinical Trial Applications across Europe and the UK, contact us at Agos Pharma via

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