News - Latest

1. From Friday 20 March only digital submission

   Due to the Cabinet's restrictive measures and adapted accessibility of the CCMO, the following provisions will apply to all ...

   News item | 19-03-2020 | 15:54

2. Wet signature obligation on decrees suspended until further notice

   As of March 20 2020, CCMO letters and CCMO decrees will temporarily not include a 'wet signature'.

   News item | 19-03-2020 | 15:14

3. UPDATE: Accessibility of CCMO due to coronavirus outbreak

   From Friday 20 March 2020, the office of the CCMO will no longer be occupied until further notice, due to the restrictive ...

   News item | 19-03-2020 | 14:59

4. From 13 March 2020, submission of research dossiers for gene therapy and medicinal products containing GMOs takes place directly to the relevant authority

   From 13 March 2020, research dossiers in the field of gene therapy and medicinal products containing GMOs must be submitted ...

   News item | 16-03-2020 | 11:45

5. Accessibility CCMO due to coronavirus outbreak

   The measures taken by the Cabinet as a result of the outbreak of the new coronavirus (SARS-CoV-2/COVID-19) also have an impact on ...

   News item | 13-03-2020 | 11:57

6. Consequences of the medical device regulation on clinical investigations

   As of May 26th 2020, the European Medical Device Regulation (EU) 2017/745 (MDR) comes into effect. The MDR brings new rules for ...

   News item | 20-12-2019 | 11:29

7. Template clinical trial agreement available for investigator-initiated research

   For investigator-initiated research, a special template is now available for the clinical trial agreement.

   News item | 20-09-2019 | 16:35

8. Update Investigational Medical Device Dossier (IMDD) available

   An update of the Investigational Medical Device Dossier (IMDD) is available.

   News item | 20-09-2019 | 10:25

9. Publish your clinical trial results in ToetsingOnline and in EudraCT database

   Sponsors are required to publish results of research subject to the WMO (Medical Research involving Human Subjects Act) in ...

   News item | 29-07-2019 | 15:32

10. Review of substantial amendments by competent authority delayed

    The CCMO as competent authority currently has a delay in reviewing substantial amendments.

    News item | 22-07-2019 | 09:55