Clinical trials of medicinal products - REG (EU) 536/2014
All ongoing clinical trials in the EU must be transitioned to the Clinical Trials Information System (CTIS) by 31 January 2025.
This date marks the end of a three-year transition period that began when the Clinical Trials Regulation (CTR) became applicable in the EU.
On 29 February 2024, the EMA and member states will offer an CTIS Bitesize Talk: How to submit a transitional trial in CTIS.
The training is free of charge and will also be made available as a recording.
As of 01 January 2023 , an updated fee tariff of the BASG was put into force.
From this date, index-adjusted tariffs will apply for
- Clinical trials of medicinal products according to Regulation (EU) 536/2014
- Clinical trials of medicinal products according to Directive 2001/20/EC.
The reduction of tariffs for academic clinical trials of medicinal products was suspended in 2022!The same fees apply as for commercial studies.
Please refer to the BASG fee schedule for the current fees.
Information from the European Commission
The basis for clinical trials with medicinal products is the Regulation (EU) 536/2014 or Clinical Trials Regulation. This is published in the Official Journal of the Commission and is directly applicable in all member states of the Union and the EEA.
Eudralex Vol.10 contains important guidances and recommendations as well as template documents prepared by the Commission's working groups. They complement the legal basis of the regulation.
Information from the European Medicines Agency (EMA)
The European Medicines Agency (EMA) manages the central submission portal for clinical trials, the Clinical Trials Information System or CTIS. The EMA has published extensive guidance support documents as well as online training materials