EU Offers More Clarity On Complying With Upcoming Clinical Trials Regulation
The European Commission has updated its guidance on the technical aspects of the Clinical Trials Regulation to clarify expectations on topics such as expanding authorized trials to additional EU member states and complying with safety reporting requirements.
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With a clear implementation date now in sight for the EU Clinical Trials Regulation, the European Commission is focusing its efforts on finalizing additional guidance and templates to support compliance. The pharmaceutical industry wants access to a test version of the new CT portal so that companies can make the necessary adjustments to their own systems.
Executive Summary: The European Medicines Agency’s management board has decided on December 2021 as the go-live date for the EU Clinical Trials Information System. It will also meet later this month to elect the EMA’s new executive director to succeed Guido Rasi.
The European Commission has issued a new template on trial recruitment and informed consent procedures and has updated its guidance on the provisions of the EU Clinical Trials Regulation that allow a trial to be conditionally authorized.