News - Latest
39 news items
European Commission agrees to postpone MDR by one year
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
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
UPDATE 27 March 2020: Procedure fast-track review by CCMO as review committee. Given the current developments around the outbreak ...
Fast track procedures MRECs
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
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 ...
Recommendations for the conduct of clinical research at the time of restrictive measures due to the coronavirus
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
From 13 March 2020, research dossiers in the field of gene therapy and medicinal products containing GMOs must be submitted ...