May 2022: Clinical Trials Regulation Update

European Medicines Agency updated the page, Clinical Trials Regulation: progress on implementation by adding ‘Key performance indicators (KPIs) to monitor the European clinical trials environment‘ document over the What’s New Section on May 20, 2022:

Under the Accelerating Clinical Trials European Union (ACT EU) initiative EMA created a new page to publish reports that include statistics on the authorization of clinical trials in the EU and European Economic Area (EEA). These reports mainly consist of the metrics for the submitted and authorized clinical trial applications along with the non-authorized clinical trials. It notifies that these reports will be published every month as part of monitoring the implementation of the Clinical Trials Regulation (CTR).

KPIs to monitor the European clinical trials environment: It is the first report posted for the period January 31, 2022, to April 30, 2022. The data is reported from the two EU clinical-trial databases (Clinical Trials Information System and European Union Drug Regulating Authorities Clinical Trials (EudraCT)). The data is divided into sponsor type, mono-national or multi-national, clinical trial phase, and therapeutic area. It consists of the following:

  1. Clinical trials submitted under CTR
  2. Clinical Trial Applications submitted under the Clinical Trials Directive (CTD)
  3. Ongoing clinical trials in CTR and CTD
  4. Clinical trials with a decision issued with/without deferrals under CTR and CTD
  5. Submitted, validated, authorized, rejected, lapsed, and withdrawn Substantial Modification (SM) applications
  6. Average time from submission to reporting date, and to first decision for initial applications and Substantial Modifications (Part I or Part I and II)

For more information, please click here.