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Clinical Trial Regulation expected to apply from December 2021
The European Medicines Agency (EMA) has announced that the EU portal ‘Clinical Trials Information System’ (CTIS) is expected to ...
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Recommendations for the conduct of clinical research at the time of restrictive measures due to the coronavirus
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Flowcharts deferred consent for medical research in emergency situations
CCMO has drawn up flowcharts to clarify when and if medical research involving subjects is allowed to take place in emergency ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...