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 and substantial amendments to these trials: Under the Clinical Trial Directive (CTD) 2001/02/EC
For trials under the CTD the same legal period of maximum 28 calendar days applies for the MEC to communicate its motivated advice. For monocentric phase I trials, this period is reduced to a maximum of 15 calendar days.
These legal periods may be extended by 30 calendar days in case of trials involving medicinal products for gene therapy (somatic cell therapy and tissue engineered products), as well as all medicinal products containing genetically modified organisms. In addition, the period already extended by 30 calendar days may be extended again by a maximum of 90 calendar days in the event of consultation of the Biosafety Advisory Council. For trials with xenogenic cell therapy there is no time limit to the authorisation period.
The same legal periods apply for the FAMHP, starting from the date of validation of the Clinical Trial Application file/substantial amendment (T0). Please note: if you receive major comments (Grounds for Non Acceptance) from the FAMHP, this period is put ‘on hold’ for a maximum of 1 month until you provide an answer and/or the adapted documents to the FAMHP.
Under the Clinical Trial Regulation (CTR) 536/2014
The approval period for clinical trials under the CTR varies from 60 to 156 calendar days (i.a. depending on the request for additional information by the RMS/MSC or the investigation of a biotech).
For studies under the Medical Device Regulation (MDR) and substantial amendments to these trials:
The approval period for clinical investigations under the MDR depends on the regulatory submission pathway which depends on the status of the investigational medical device and can vary between 28 to 60 calendar days. For more detailed information the ‘Guideline on Submission Processes of Clinical Investigations according to MDR in Belgium’ document on the website of FAMHP can be consulted.
Substantial modifications to clinical investigations approved under the Medical Device Directive (MDD) must follow the MDD procedure for the approval of the modification, also after 26 May 2021. The MEC and FAMHP have a legal period of maximum 28 calendar days to communicate their motivated advice.