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  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