December 15, 2025
IIPOPI at EMA Joint Meeting: Shaping EU Medicines Policy
On 18–19 November 2025, Otilia Stanga, IPOPI Board Member/Treasurer, participated as IPOPI’s representative in the joint meeting of the European Medicines Agency (EMA) with the Patients’ and Consumers’ Working Party (PCWP) and the Healthcare Professionals’ Working Party (HCPWP). The meeting brought together patient, consumer and healthcare professional organisations from across Europe.
Discussions covered a broad range of strategic topics shaping the future of medicines in the EU, including the new pharmaceutical legislation, clinical trials, real-world evidence, medicine shortages, gender equality in women’s health, updates to product information, and EMA’s communication and outreach activities.
A key highlight was the presentation of EU DARWIN, the real-world data network supporting regulatory decision-making. Two important studies were showcased: one examining the safety of GLP-1 receptor agonists in relation to suicide and self-harm risks, and another focused on frailty and polypharmacy in older adults with cancer. These initiatives underline the growing importance of real-world evidence in medicines regulation.
Important updates were also shared on the Cancer Medicines Forum (CMF) and the ACT EU multi-stakeholder platform, reinforcing patient involvement in clinical trials governance.
The session on international EMA activities highlighted global regulatory challenges, including the limited number of countries in Africa with WHO-recognised medicines regulatory capacity. The discussion on medicine shortages was particularly relevant for our community, with updates on critical medicines, contingency stocks versus stockpiling, and ongoing shortages affecting products such as immunoglobulins.
For IPOPI, these discussions are highly relevant, especially regarding plasma-derived medicinal products, clinical trials, regulatory science, and shortages. The meeting once again demonstrated the vital role of patient organisations in shaping EU medicines policy and ensuring that the patient voice remains central in regulatory decision-making.
