Legally binding review timelines
The review timelines for trials in which a medicinal product is investigated are laid down in the WMO. The review timeline starts on the day that the reviewing committee and the competent authority receives a complete research file.
For most studies with medicinal products the reviewing committee (an accredited MREC
or special cases the CCMO) has a maximum of 60 days after receipt of the complete (primary) submission to reach a decision. Within this timeline of 60 days, the reviewing committee can request additional information from the applicant. The review times for clinical trials with gene therapy medical products (GTMPs), somatic cell therapy medical products (sCTMPs) and genetically modified organisms (GMOs) is 90 days.
The competent authority (the CCMO or in special case the MEB) has a short time line for its marginal review: 14 days. In case of substantial amendments, both the reviewing committee and the competent authority has 35 days to complete the review.
The review time for clinical trials with medicinal products is 60 days, while the review time for trials with gene therapy medicinal products (GTMPs), somatic cell therapy medicinal products (sCTMPs) and trials with genetically modified organisms (GMOs) is 90 days. For all others studies the review timeline is 56 days (8 weeks).
Clock stop
Upon requesting additional information, the review timeline is halted (‘clock stop’) and the reviewing committee will inform the applicant of this. After receipt of the requested additional information the reviewing committee will finalize their review. For studies in which a Genetically Modified Organism (GMO), a gene therapy, or a cell therapy product is investigated, the review timeline have a maximum of 90 days.
Review timeline for all other studies
For studies with human subjects, gametocytes, surplus embryos or fetus in utero for which the review timelines are not laid down in the WMO and Embryo Act respectively, the general timelines of the General Administrative Law Act (Dutch: Algemene wet bestuursrecht, or Awb) apply.
According to this act the reviewing committee have maximum 8 weeks (56 days) to reach a decision. This period can extended by a second period of maximum 8 weeks. Also for these type of studies a clock stop is introduced when the reviewing committee request additional information from the applicant.
Committee Finder tool reveals the timelines
As described above the various type of studies and submissions to different bodies have different statutory timelines. For investigators and companies it is not immediately obvious which review timeline apply for their studies.
"Committee Finder tool reveals review timelines"
We therefore incorporated the various review timeline in the Committee Finder (CoF), the tool we described extensively in the two previous themes of this online course. Once you have selected the right reviewing committee, the tool will provide you with review timelines that apply for your research file.