Primary submission to the reviewing committee
The review timeline starts on the day that the accredited MREC or CCMO receives the complete submission.
The accredited MREC or the CCMO sends a confirmation of receipt . The reviewing committee may refer to ToetsingOnline, where the review timeline can be followed. The timeline depends on the type of submission. There are different (legal) timelines for different types of research.[W1]
For ‘general’ medical research, that is, not a research with a medicinal product, a so-called ‘reasonable timeline’ of 8 weeks applies, on the grounds of the General Administrative Law Act (Awb, in Dutch). This means that the MREC or CCMO has a maximum of 8 weeks to reach a decision, unless the MREC or CCMO has given notice of requiring more time, though this must be made known within that timeline. If this is the case the MREC or CCMO must state the extension timeline during which a decision can be expected. The MREC or CCMO usually applies a very reasonable and short (as possible) extension to the initial timeline. The extension can have a maximum duration of 8 weeks.
The MREC or CCMO can stop a timeline for a set period (clock stop) if they have questions/suggestions regarding a submission. If this is the case, they will let the submitting party know by way of written letter. The timeline starts again at the moment the MREC or the CCMO has received the reaction by the submitting party. Once again, they will let the submitting party know of this in the form of a written letter. They will also give the timeline during which the decision will be made. The MREC sends its decision within 7 working days to the submitting party.
Failure of the MREC or the CCMO to reach a decision concerning a request for review within the set timelines can result in the Penalty and Appeal Act (Wet dwangsom en beroep bij niet tijdig beslissen, in Dutch).
Primary submission research with a medicinal product
Specific review timelines for research with a medicinal product are laid down in the WMO. An accredited MREC or the CCMO has in principle a maximum of 60 days after receipt of the complete (primary) submission to come to a decision. The MREC or the CCMO can request additional information once within this timeline of 60 days and in doing so introduces a ‘clock stop’. The MREC or the CCMO will inform the submitting party of this. After receipt of the additional information the MREC or the CCMO will let the submitting party know the timeline within they can expect a decision.
The WMO offers the possibility to extend this review timeline for certain types of research with a maximum of 30 days (on top of the previously mentioned timeline of 60 days). In these cases the review timeline can have a maximum of 90 days. This applies to medical research with medicinal products for gene therapy/medicinal product with GMO and somatic cell therapy.
No specific timeline applies to the review of research with a medicinal product for xenogenic cell therapy. The so-called ‘reasonable timeline’ of the General Administrative Law Act applies, that is 8 weeks, with the possibility to extend for a further 8 weeks. A moratorium applies to this kind of research.
Research with a medicinal product must undergo an extra review by the competent authority. Go to Research with a medicinal product & extra review competent authority and to Timelines competent authority for more information.