EU regulators are to speed up their evaluation of applications to transition ongoing multinational studies to the CTR.
With approximately 18 months remaining for studies authorized under the erstwhile EU Clinical Trials Directive (CTD) to switch to the Clinical Trials Regulation (CTR), member states have agreed on a new expedited, one-week evaluation procedure to support the transition of multinational clinical trials meeting certain requirements.
The expedited procedure is explained in a “best practice guide” drawn up by the Clinical Trials Coordination Group (CTCG),...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
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