EMA: Use of CTIS mandatory in the EU
As we already reported in December 2022, the use of the Clinical Trials Information System (CTIS) is now obligatory in the EU.
Since January 31, CTIS has been the single access point for sponsors and regulators of primary clinical trials when it comes to submitting and assessing clinical trial data.
This follows a one-year transition period during which sponsors had the choice of whether to apply for a new clinical trial in the EU or EEA under the Clinical Trials Directive or according to the new Clinical Trials Regulation (CTR).
In the past, sponsors had to submit clinical trial applications separately to national competent authorities and ethics committees in each country.
But with CTIS, sponsors will now be able to apply for approvals in up to 30 EU/EEA countries at the same time and with the same submission documents.
By the end of January 2025, all ongoing trials approved under the Clinical Trials Directive 2001/20/EC will fall into the new regulation and will have to be transferred to CTIS.
Source:
Meet the GMP Compliance Adviser
The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.
The demo access is non-binding and ends automatically.
You may also be Interested in the Following Articles:
