The review process for clinical research involving investigational medicinal products
As in all EU member states, the Netherlands uses a dual review process for clinical research involving investigational medicinal products, that is, the research file must be submitted to both a reviewing committee and the Competent Authority. This process is regulated in the European Clinical Trial Directive 2001/20/EC.
In most cases, an accredited MREC
serves as the reviewing committee, performing a review of the scientific, medical, and ethical aspects of the proposed clinical study. For these studies, the CCMO serves as the Competent Authority. The CCMO registers the study with the EudraCT database and screens the EudraVigilance database for any adverse reactions that were not reported in the Investigator’s Brochure and could change the investigational medicine’s risk profile.
If the CCMO finds no reason to reject the proposal, it issues a declaration of “no grounds for non-acceptance”; if the accredited MREC then approves the research file, the clinical study can begin, including the recruitment of subjects, healthy volunteers, and/or patients.
"The new European Clinical Trial Regulation 536/2014, which will be in force from January 31 2022 onwards, will drastically change the process for reviewing clinical research involving investigational medicinal products in the EU."
For clinical research involving investigational medicinal products for which the accredited MREC is not authorized to review, the CCMO serves as the reviewing committee. In this case, the Medicines Evaluation Board (MEB; in Dutch: College ter Beoordeling van Geneesmiddelen or CBG) will serve as the Competent Authority on behalf of the Ministry of Health, Welfare and Sport (in Dutch: Ministerie van Volksgezondheid, Welzijn en Sport or VWS).
From January 31 2022 onwards, the current European Clinical Trial Directive 2001/20/EC will be replaced by the European Clinical Trial Regulation 536/2014. As a result, the process for reviewing clinical research involving investigational medicinal products will change considerably in all EU members states.
In the Netherlands one important change is the number of accredited MRECs that will be authorized to review research files concerning clinical studies with investigational medicinal products. Approximately half of the current accredited MRECs will review these studies once the EU Clinical Trial Regulation is implemented.