Summary

The EU Clinical Trials Directive (CTD) has been fully implemented in The Netherlands. Prior to beginning a clinical trial, an identical Clinical Trial Application (CTA) dossier must be submitted to an accredited Ethics Committee (EC) and to the Central Commission on Research in Humans (the Competent Authority [CA] in The Netherlands). By law, the Dutch CA performs an abbreviated CTA review within 14 days.

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Favorable Regulatory Procedures In The Netherlands Phase I-IIa

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