The EMA has released the new Clinical Trials Regulation, replacing the Clinical Trials Directive.
The Clinical Trials Regulation was first put into effect on 16 June 2014. However, due to a bottleneck in developing a fully functional EU clinical trials portal and database, which is the backbone of the new regime for clinical trials in Europe, the Regulation had to be postponed.
However, on 21 April 2021, the European Medicines Agency (EMA) Management board confirmed that the EU Portal and Database are fully functional. Subsequently, the date of applicability for the Regulation was set for 31 January 2022.
The overarching goal of the Regulation is to “ensure a greater level of harmonization of the rules for conducting clinical trials throughout the EU.” (see European Commission’s overview) Thereby it especially targets facilitating the execution of multinational clinical trials.
Two other major goals of the Regulation are to provide more transparency on clinical trials data and to simplify the rules on safety reporting.
To ensure the former, all data for clinical trials will now be publicly accessible, unless a breach of confidentiality can’t be ruled out on the basis of:
Protection of commercially confidential information
Protection of personal data
Protection of confidential communication between EU countries
Ensuring effective supervision of the conduct of clinical trials by EU countries
In order to simplify the rules on safety reporting the Regulation requires that:
The protocol may provide that not all adverse events (AE) and serious adverse events are recorded and reported.
For a clinical trial involving more than one investigational medicinal product (IMP), a single annual safety report on all IMPs used in that trial can be submitted in the Clinical Trials Information System (CTIS).
Suspected unexpected serious adverse reactions (SUSARs) need to be reported via the EudraVigilance database.
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