The regulatory frameworks in the life sciences and healthcare sector keep evolving rapidly and dynamically. Several important legislative reforms have been adopted over the last years, which are set to impact players in the...more
1/28/2025
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Technology Sector
Following a public consultation period this summer, the European Medicines Agency (EMA) published revised transparency rules (s. here) for the EU Clinical Trials Information System (CTIS) on 6 October 2023. The CTIS serves as...more
The Clinical Trial Regulation (EU) No 536/2014 (CTR) became fully applicable yesterday (31 January), following the end of the transition period. Therefore, the use of the Clinical Trial Information System (CTIS) is mandatory...more