On November 27, 2025, European regulators and ethics committees agreed to pilot FAST‑EU, a new fast‑track approach for authorizing multinational clinical trials. Launching in January 2026, this initiative aims to deliver quicker, more predictable approvals while upholding Europe’s high scientific, ethical, and safety standards.

The statistics have been updated.

The following is a list of the most common considerations that occur in the area of validation.

EMA Clinical trials Map

Below you will find all important information about the changes in the radiation protection act applicable since 01.07.2025.

For studies with submission in CTIS and DMIDS, only one radiation protection submission is required - depending on the study focus CTIS or DMIDS.

Effective July 1, 2025, new regulations will apply to radiation protection approvals or notifications for clinical trials.

The article provides information on the correct procedure for approval procedures in accordance with Section 31 StrlSchG (Strahlenschutzgesetz (German Radiation Protection Act)) in the context of CTR applications and Substantial Modification in CTIS.

This article provides information on the correct procedure for reporting a notification procedure in accordance with Section 32 StrlSchG (Strahlenschutzgesetz (German Radiation Protection Act)) as part of CTR submission and for Substantial Modifications in CTIS.

Modern study protocols for phase I or phase I/IIa clinical trials (‘early phase clinical trials’) often include several classic phase I clinical trials in the form of integrated, consecutive sub-studies.

"Compassionate Use" was introduced into the German legislation with the 14th amendment of the German Medicinal Product Act (AMG) and modified by the amendment of the German Medicinal Product Act in July 2009.

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Section 3a of the Ordinance on the Prescription of Medicinal Products ("Arzneimittelverschrei­bungsverordnung", AMVV) of 21 December 2005 (BGBl. I p. 3632) as last amended by Article 1 of the Ordinance of 19 February 2013 (BGBl. I p. 312) applies to the use of medicinal products containing thalidomide, lenalidomide or pomalidomide, in clinical trials.

Answers to frequently asked questions regarding the new form of annual safety report, the DSUR, have been harmonised on the European level by the Clinical Trial Facilitation Group (CTFG).