Brexit and clinical research
09-07-2020 | 12:16
The United Kingdom (UK) has left the European Union (EU) on 31 January 2020. A transitional period is now in place until 31 ...
Conditions for (re)starting clinical research
25-06-2020 | 17:19
The Health and Youth Care Inspectorate (IGJ) has published a document with the conditions for the (re)start of clinical research ...
Clinical Trial Regulation expected to apply from December 2021
17-06-2020 | 09:34
The European Medicines Agency (EMA) has announced that the EU portal ‘Clinical Trials Information System’ (CTIS) is expected to ...
Conditions for (re)starting studies in clinical research units
10-06-2020 | 15:08
CCMO has published a document on the conditions for the (re)start of studies in clinical research units.
Recommendations for the conduct of clinical research at the time of restrictive measures due to the coronavirus
26-05-2020 | 13:24
Flowcharts deferred consent for medical research in emergency situations
12-05-2020 | 16:27
CCMO has drawn up flowcharts to clarify when and if medical research involving subjects is allowed to take place in emergency ...
MDR postponed by one year to 26 May 2021
24-04-2020 | 13:31
The moment of ratification of the European Medical Device Regulation (EU no 2017/745 (MDR)) has been postponed by one year due to ...
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 ...
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 ...