Clinical trials of medicinal products - REG (EU) 536/2014 New
End of the transition period for initial applications
From January 31, 2023, all initial applications for new clinical trials in the EU and EEA must be submitted via the Clinical Trials Information System (CTIS) in accordance with the Clinical Trials Regulation (EU) 536/2014 and will subsequently be subject to the requirements of that Regulation.
Applications for authorisation of clinical trials in accordance with Directive 2001/20/EC are therefore no longer possible
BASG fee schedule for clinical studies
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 and training material
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.
Regulation (EU) 536/2014 - Clinical Trials Regulation (CTR)
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.
Eudralex Vol.10 - EU Commission Guidance on Clinical Trials
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
General information on the CTR
The Clinical Trials Information System (CTIS)