Best Practise for multinational transition trials
A timely transition to CTR of investigator initiated trials with medicinal product is important. This can only be done thru the online submission portal CTIS. Clinical trials with medicinal products that have at least one active site on the 30th of January 2025 must be transitioned to CTR. Trials that are not yet approved according […]
31 January 2023 CTR applicable for new trials with medicinal products
On 31 January 2023, the EU Clinical Trial Regulation (CTR) will be applicable for new clinical trials with a medicinal product. The CTR became applicable as of 31 Januari 2022. A transition period of three years started. During the first year, sponsors can choose to submit a clinical trial application according to the current legislation, […]
Clinical Trial Regulation expected to apply from 31 January 2022
The European Medicines Agency (EMA) has announced that the EU portal ‘Clinical Trials Information System’ (CTIS) is expected to go live from 31st of January 2022. See the original news item on the website of the CCMO: link