Timelines 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.