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Focus on Regulation

Tag Archives: access to clinical trial data

EMA launches public consultation on the use of patient disease registries for regulator purposes

Introduction On 5 November 2018, the EMA published a discussion paper concerning the use of patient disease registries for regulator purposes. The discussion paper was published within the context of the EMA’s Patient Registries Initiative (PRI). The consultation period is open to stakeholders until 29 June 2019. It has been published to allow stakeholders to

The EFPIA and PhRMA principles for responsible sharing of clinical trial data enter into force on 1 January 2014

On 1 January 2014, the joint Principles for Responsible Clinical Trial Data Sharing (“the Principles”) endorsed by the European Federation of Pharmaceutical Industries and Associations (“EFPIA”) and Pharmaceutical Research and Manufacturers of America (“PhRMA”) entered into force. EFPIA and PhRMA endorsed these Principles on 24 July 2013. The Principles are available at EFPIA website. The