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.
New online tool makes CTR scope more transparent
23-12-2021 | 17:12
The new Clinical Trial Decision Tool helps you to determine whether your study with a medicinal product falls within the scope of ...
CCMO kicks off programme on patient participation in clinical trials
23-12-2021 | 17:11
To promote patient participation in clinical trials, CCMO is launching a programme to cooperate actively with other parties. ...
New EMA document for sponsors on CTIS
10-12-2021 | 09:41
The European Medicines Agency (EMA) has published a new document on the Clinical Trials Information System (CTIS). The document ...
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 ...