EMA Transparency journey and impact on its stakeholders

9:20 AM - 10:00 AM

The European Medicines Agency was established in 1995. This signalled the start of an incredible journey whereby EMA took a strong stance to ensure that EU citizens have access to information about new medicines it approved, safety concerns that arise, and, many more aspects affecting public health. 

The COVID-19 pandemic highlighted the high demand for transparency from the public, including on data supporting the approval of medicines developed in an emergency context. Recent requirements stemming from the EU Clinical Trial Regulation and EMA’s extended mandate also reflect ongoing efforts to increase transparency and acknowledge that public trust is key to ensure uptake of necessary medicines. 

EMA’s transparency journey has been going on for nearly three decades and is set to continue. Facilitating public scrutiny of its opinions and maintaining trust in the system to empower its stakeholders to make informed decisions are key drivers for EMA.

Due to new requirements, such as those from the clinical trial regulation, medical writers working for industry will also play a greater role in providing information about medicines to the wider public.