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, the Regulation had to be postponed 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.
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 mainly targets facilitating the execution of multinational clinical trials.
Two other primary goals of the Regulation are to provide more transparency on clinical trial data and simplify the safety reporting rules.
To ensure the former, all data for clinical trials will now be publicly accessible unless a breach of confidentiality can’t be ruled out based on:
Protection of commercially confidential information
Protection of personal data
Protection of confidential communication between EU countries
Ensuring adequate supervision of the conduct of clinical trials by EU countries
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 to the Clinical Trials Information System (CTIS).
Suspected unexpected severe adverse reactions (SUSARs) must be reported via the EudraVigilance database.
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