EU Clinical Trial Regulation (CTR)
On 31 January 2022, the EU Clinical Trial Regulation (CTR) 536/2014 will apply with new rules for research with medicinal products in the European Union.
EU Medical Device Regulation (MDR)
On May 26, 2021, the EU Medical Device Regulation 2017/745 (MDR) has come into effect with specific rules for the submission, review and conduct of clinical investigations with medical devices.
CCMO closed between Christmas and New Year’s Eve
01-12-2021 | 15:30
Due to the holiday season, CCMO will be closed from Monday 27 December 2021 to Monday 3 January 2021.
Information EU Clinical Trial Regulation available on CCMO's website
15-11-2021 | 15:47
On 31 January 2022, the EU Clinical Trial Regulation (CTR) 536/2014 will apply with new rules for research with medicinal ...
New directive makes use of Site Suitability Declaration (VGO) obligatory for research with a medicinal product as of 1 November 2021
18-10-2021 | 09:00
CCMO’s directive on the assessment of the suitability of research centres (TGO) has been adopted and will apply to studies with ...
Rates established for assessment of research under CTR and MDR
17-09-2021 | 11:13
The Ministry of Health, Welfare and Sport has set the rates for medical ethical review in the Netherlands of research under the ...
Clinical Trial Regulation (CTR) applicable from 31 January 2022, VHP concludes on 15 October 2021
04-08-2021 | 10:38
On 31 July, the European Commission has announced in the Official Journal of the European Union that the Clinical Trial ...
Site Suitability Declaration (VGO) as of 1 November 2021 obligatory for research with a medicinal product
09-07-2021 | 14:55
As of 1 November 2021, use of the Site Suitability Declaration [Verklaring Geschiktheid Onderzoeksinstelling, VGO] will become ...