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 ...
03-04-2020 | 15:44
Due to the exceptional circumstances, the Ministry of Infrastructure and Water Management (IenW) has decided to accelerate the ...
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 ...
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 ...
20-03-2020 | 17:23
The European Commission, the European Medicines Agency (EMA) and national Head of Medicines Agencies (HMA) have published a ...
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 ...
19-03-2020 | 15:14
As of March 20 2020, CCMO letters and CCMO decrees will temporarily not include a 'wet signature'.
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 ...
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 ...
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 ...
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 ...
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 ...
20-09-2019 | 16:35
For investigator-initiated research, a special template is now available for the clinical trial agreement.
20-09-2019 | 10:25
An update of the Investigational Medical Device Dossier (IMDD) is available.
29-07-2019 | 15:32
Sponsors are required to publish results of research subject to the WMO (Medical Research involving Human Subjects Act) in ...
22-07-2019 | 09:55
The CCMO as competent authority currently has a delay in reviewing substantial amendments.
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 ...
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 ...
