News - Latest

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. Accessibility CCMO due to coronavirus outbreak

   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 ...

   News item | 13-03-2020 | 11:57

10. Consequences of the medical device regulation on clinical investigations

    As of May 26th 2020, the European Medical Device Regulation (EU) 2017/745 (MDR) comes into effect. The MDR brings new rules for ...

    News item | 20-12-2019 | 11:29