Full or staggered application in the Netherlands
In the Netherlands, the assessment of national and multinational studies will be done by an accredited MREC qualified to review clinical trials or the CCMO (qualified to review specific types of clinical trials).
These committees will be responsible for the Part I and Part II assessment including ethical review. This means one integrated assessment by one committee within the timelines set. It is therefore advised to submit Part I and Part II in parallel.
For certain clinical trials, the RMS can extend the assessment period part I by max 50 days for the consulting of experts. In that case, the timeline for part I may be longer than for part II which may result in complex applications. Therefore, the sponsor might consider a staggered applications for these type of clinical trials:
- clinical trials with an ATMP;
- clinical trials with a medicinal product developed by means of biotechnological processes like recombinant DNA technology or controlled expressions of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells or hybridoma and monoclonal antibody methods.