The European Federation of Pharmaceutical Industries and Associations is committed to advancing public health goals through the responsible sharing of clinical trials data, in line with the requirements of the Clinical Trials Regulation. Responsible data sharing must safeguard, patient privacy, preserve scientific rigour and trust in regulatory systems and maintain incentives for investment in biomedical research.

EFPIA has already contributed ideas on the topic of clinical trials transparency during EMA public workshops and the agency's draft consultations. We fully support the EMA's self-expressed aim of achieving a balanced approach with a view to protecting public health and fostering the innovation capacity within European medical research.

At the same time, EFPIA expresses some concerns with the EMA proposal, which we have addressed in our response to the recent consultation. We have highlighted, for example, the risk of establishing an overly-complicated and non-user-friendly system. EFPIA supports the publication of information via a single portal/repository that is harmonised with international standards.  We remain committed to working with all stakeholders to support the continued development of responsible transparency