Information CCMO due to coronavirus outbreak
On this page you will find our news items following the coronavirus outbreak (COVID-19). The messages are listed in chronological order, with the latest message or updated message at the top.
Latest update 3 April 2020: Emergency regulation for authorisation of research into COVID-19-targeted gene therapy or medicinal product containing GMO
Please note: If necessary, the messages will be adjusted or supplemented after publication, so keep a close eye on our website for updates.
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 has decided to accelerate the authorisation procedure for research into gene therapy or a medicinal product containing a genetically modified organism (GMO), that is aimed at combating COVID-19. For more information we refer you to the following page.
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.
CCMO receives many queries on problems caused by the coronavirus and its effects on the conduct of clinical research. Examples concern the delivery of study medication, subjects unable to come to the investigational site as a result of which certain study procedures cannot be carried out, and the postponement of monitoring activities. Our website provides a number of recommendations in this respect, in which in some cases the review committee (CCMO or accredited MREC) must be informed.
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 of the new coronavirus (COVID-19), CCMO facilitates an accelerated review of research files concerning studies on COVID-19 (fast-track procedure). For more information we refer you to the following page.
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 on the occurrence and/or treatment of COVID-19. For more information we refer you to the following page.
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 guidance for sponsors and investigators on how to manage the conduct of clinical trials during the coronavirus disease (COVID-19) pandemic. For more information we refer you to the following page.
From Friday 20 March only digital submission
Due to the Cabinet's restrictive measures and adapted accessibility of the CCMO, all documents must be submitted digitally as of Friday 20 March until further notice. For more information we refer you to the following page.
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'. For more information we refer you to the following page.
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 measures imposed by the coronavirus outbreak. As a result, CCMO will not be directly accessible by telephone for the time being. For more information on what to keep in mind when contacting us we refer you to the following page.
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 directly to the relevant authority (CCMO as review committee, Ministry of Health, Welfare and Sport as competent authority or Ministry of Infrastructure and Water Management (GMO Office)). The measure below, which was planned because of digitalisation, is now effective immediately because of the coronavirus outbreak. For more information, please read our news item.
Notification via email about submission by post
Did you recently submit documents to CCMO by post, such as a research file, substantial amendment, administrative appeal or objection? If so, we ask you to send an email to email@example.com in which you inform us that documents are on their way by post. This allows us to ensure that the submitted documents will be processed adequately after receipt. Clearly state in your email which documents are involved and which study (NL-number) your submission concerns.