For experiments under the law of May 7th 2004, retrospective studies, studies on residual human body material and amendments to these studies:
As described in the Belgian law on experiments, the MEC has a period of maximum 28 calendar days to communicate its motivated advice to the researcher. This also applies for studies that do not fall under the law of May 7th 2004. Please note: if you receive advice for changes, extra attachments or the like, these 28 calendar days are put ‘on hold’. The days continue again from the moment you provide an answer and/or the adapted documents to the MEC.
For clinical trials under the Clinical Trial Regulation (CTR) and substantial modifications to the trials:
The approval period for clinical trials under the CTR varies from 60 to 106* calendar days (depending on the request for additional information by the RMS/MSC).
The approval period for substantial modifications to clinical trials under the CTR varies from 49 to 95* calendar days (depending on the request for additional information by the RMS/MSC).
* This period may extend by a further 50 calender days for clinical trials involving an advanced therapy investigational medicinal product (ATMP).
For studies under the Medical Device Regulation (MDR) / In Vitro Diagnostic Medical Devices Regulation (IVDR) and substantial modifications to these studies:
The approval period for clinical investigations/performance studies and substantial modifications under the MDR/IVDR depends on the regulatory submission pathway which depends on the status of the investigational (in vitro diagnostic) medical device and can vary between 28 to 65 calendar days.
- For more detailed information about the MDR the ‘Guideline on Submission Processes of Clinical Investigations according to MDR in Belgium’ document on the website of FAMHP can be consulted.
- For more detailed information about the IVDR the ‘Guideline on Submission Processes of Performance Studies according to IVDR in Belgium’ document on the website of FAMHP can be consulted.
Do I need to prepare a final report?
Within a year after the end of trial (i.e. the last visit of the last patient) a final study report has to be submitted to the EC and/or FAMHP, either as a report/summary or as a publication. HIRUZ CTU will contact the investigator with regard to the final report preparation.