HEDS is part of the School of Health and Related Research (ScHARR) at the University of Sheffield. We undertake research, teaching, training and consultancy on all aspects of health related decision science, with a particular emphasis on health economics, HTA and evidence synthesis.

Thursday, 22 May 2014

EMA guidance on parallel scientific advice with HTA bodies

The European Medicines Agency (EMA) has published for public consultation draft guidance for parallel scientific advice procedures involving the EMA and health-technology-assessment (HTA) bodies.

The draft guidance sets out the different phases of the process for EMA-HTA parallel scientific advice, highlights timelines and actions for all parties, and provides a briefing document template.  The template includes those aspects of any planned economic evaluation that need to be addressed.

Stakeholders are invited to provide comments on the proposed process by 14 July 2014.