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72 news items
European guidance for management clinical trials during corona crisis
The European Commission, the European Medicines Agency (EMA) and national Head of Medicines Agencies (HMA) have published a ...
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 ...
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'.
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 ...
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 ...
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 ...
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 ...
Template clinical trial agreement available for investigator-initiated research
For investigator-initiated research, a special template is now available for the clinical trial agreement.
Update Investigational Medical Device Dossier (IMDD) available
An update of the Investigational Medical Device Dossier (IMDD) is available.
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 ...