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MDR postponed by one year to 26 May 2021

The moment of ratification of the European Medical Device Regulation (EU no 2017/745 (MDR)) has been postponed by one year due to ...

News item | 24-04-2020 | 13:31

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 ...

News item | 03-04-2020 | 17:35

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 ...

News item | 03-04-2020 | 15:44

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 ...

News item | 27-03-2020 | 16:39

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 ...

News item | 26-03-2020 | 14:45

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 ...

News item | 20-03-2020 | 17:23

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

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

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

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