White Paper

Regulatory Approval Of Clinical Studies In The Netherlands

Source: PRA Health Sciences

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 has to  be submitted in parallel to an accredited Ethics Committee and to the Centrale Commissie  Mensgebonden Onderzoek (CCMO=Competent Authority). The study can start when and  a favorable opinion from the Ethics Committee and a statement of no-objection from the Competent Authority has been obtained. General considerations are as follows:

Competent Authority

  • As of January 1st, 2008, the Competent Authority will only accept electronic submissions (CD-ROM)
  • The review of the dossier for clinical research is primarily conducted by the accredited Ethics Committee. In addition, the Competent Authority should decide whether there are “grounds for non-acceptance” concerning the clinical trial.
  • The assessment period starts as soon as the complete application is received. No confirmation of receipt will be sent to the applicant, but the applicant will be able to see if the assessment period has started on the website https://toetsingonline.ccmo.nl (and if the application was complete). The Competent Authority has maximum 14 days to review the dossier. If no notification is received from the Competent Authority within the 14-day period, PRA will contact the Competent Authority to assess the reason for not receiving the notification, and will work with the Competent Authority to obtain the notification without further delay
  • If the Competent Authority notifies the applicant of grounds for non-acceptance, the applicant may amend the application once.
  • There are special rules for clinical trials of medicinal products for gene therapy, somatic cell therapy, and for products containing genetically modified organisms. For  these products, the Competent Authority is allowed an additional 30 days for the review.