Transparency of clinical trial data: EMA publishes a new guideline

The EMA has issued “External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use”.  The European Medicines Agency policy on the publication of clinical data for medicinal products for human use (referred to as ‘Policy 0070’) was developed by the European Medicines Agency (EMA), in accordance with Article 80 of Regulation (EC) No 726/2004. Policy 0070 was adopted by the EMA Management Board on 2nd October 2014 and subsequently published on the EMA website.  Phase 1 of this policy entered into force on 1st January 2015 and pertains to publication of clinical reports only.  Phase 2 which will be implemented at a later date relates to the publication of individual patient data (IPD). In order to ensure that Policy 0070 meets its objectives the EMA has issued this guidance document.

The guidance covers the following areas:

  • External guidance on the procedural aspects related to the submission of clinical reports for the purpose of publication in accordance with EMA Policy 0070.
  • External guidance on the anonymisation of clinical reports for the purpose of publication in accordance with EMA Policy 0070.
  • External guidance on the identification and redaction of commercially confidential information in clinical reports submitted to EMA for the purpose of publication in accordance with EMA Policy 0070.

Clarification is provided on when clinical reports will be published i.e. following the conclusion of which regulatory procedures, and also which clinical reports should be submitted for publication.

The full text of the guidance can be found here.