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Focus on Regulation

Tag Archives: EFPIA

A broader definition of “unmet needs” has been proposed to support the development of anti-bacterial medicinal products

The concept paper The EMA has published a “Concept paper on preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections.” In the Concept Paper, the EMA proposes to merge the “Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 Rev 2)” with

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