European Commission agrees to postpone MDR by one year
03-04-2020 | 17:35
Due to the corona crisis, the European Commission has accepted the proposal to postpone the commencing date of the European ...
Emergency regulation for authorisation of research into COVID-19-targeted gene therapy or medicinal product containing GMO
03-04-2020 | 15:44
Due to the exceptional circumstances, the Ministry of Infrastructure and Water Management (IenW) has decided to accelerate the ...
Accelerated procedure (fast track) review of coronavirus research files
27-03-2020 | 16:39
UPDATE 27 March 2020: Procedure fast-track review by CCMO as review committee. Given the current developments around the outbreak ...
Fast track procedures MRECs
26-03-2020 | 14:45
Along with CCMO, a number of accredited MRECs have also set up fast track procedures for the accelerated review of research files ...
European guidance for management clinical trials during corona crisis
20-03-2020 | 17:23
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
19-03-2020 | 15:54
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
19-03-2020 | 15:14
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
19-03-2020 | 14:59
From Friday 20 March 2020, the office of the CCMO will no longer be occupied until further notice, due to the restrictive ...
Recommendations for the conduct of clinical research at the time of restrictive measures due to the coronavirus
16-03-2020 | 17:21
UPDATE 2 April 2020: Information on deferred consent in clinical trials in an emergency situation, see last bullet. CCMO receives ...
From 13 March 2020, submission of research dossiers for gene therapy and medicinal products containing GMOs takes place directly to the relevant authority
16-03-2020 | 11:45
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
13-03-2020 | 11:57
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
20-12-2019 | 11:29
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
20-09-2019 | 16:35
For investigator-initiated research, a special template is now available for the clinical trial agreement.
Update Investigational Medical Device Dossier (IMDD) available
20-09-2019 | 10:25
An update of the Investigational Medical Device Dossier (IMDD) is available.
Publish your clinical trial results in ToetsingOnline and in EudraCT database
29-07-2019 | 15:32
Sponsors are required to publish results of research subject to the WMO (Medical Research involving Human Subjects Act) in ...
Review of substantial amendments by competent authority delayed
22-07-2019 | 09:55
The CCMO as competent authority currently has a delay in reviewing substantial amendments.
Changes regarding submission of clinical trial agreement
21-05-2019 | 13:29
From today, the signed version of the clinical trial agreement (CTA) may be submitted to the review committee (accredited MREC or ...
Brexit and clinical research
01-03-2019 | 13:42
It is currently uncertain when the United Kingdom (UK) is going to leave the European Union (EU), whether an agreement is going ...