Shaping the Future of EU Pharmaceutical Regulation: Current Framework, Reform, and Beyond

Conference Details

Date: 25 September 2025

Time: 09:00

Duration: 2 days

Location: Brussels, Belgium

Cost: € 610 - € 720

Organiser: EIPA - European Institute of Public Administration

Conference Website

Conference Description

The conference will unite key stakeholders to assess the EU pharmaceutical framework, regulatory reforms, and the broader policy landscape. The event will also address initiatives such as the Critical Medicines Act, measures to combat antimicrobial resistance, and the EU’s push to boost biotechnology and biomanufacturing.

The European Union’s pharmaceutical regulatory framework has long been recognised by policymakers and experts alike as a global benchmark. It ensures that medicinal products are safe, effective, and accessible across the internal market. However, the rapidly evolving healthcare landscape, marked by technological innovation, growing public health demands, geopolitical tensions, and supply chain vulnerabilities, calls for critical reflection and reform. The European Commission has responded with the most significant legislative proposals in over two decades, aiming to make EU pharmaceutical law more flexible, responsive, and future proof.

In this context, the upcoming conference “Shaping the Future of EU Pharmaceutical Regulation: Current Framework, Reform, and Beyond” offers a unique and timely opportunity for stakeholders to come together and scrutinise not only the existing legal regime and the ambitious reform agenda currently on the table, chiefly represented by the Proposal for a Directive on the Union code relating to medicinal products for human use (COM(2023) 192 final) and the Proposal for a Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency (COM(2023) 193 final), but also the broader regulatory ecosystem in which these reforms are unfolding.

The conference will also focus on parallel initiatives that are shaping the future of pharmaceutical policy and life sciences in the EU. These include the Critical Medicines Act, which aims to secure supply chains and enhance the EU’s resilience against medicine shortages; the Commission’s Recommendation on Antimicrobial Resistance, addressing one of the most pressing public health threats through coordinated action; and the Commission’s targeted initiatives to boost biotechnology and biomanufacturing, recognising their role in strengthening Europe’s strategic autonomy and fostering innovation in life sciences.

What you will learn

Attendees will leave with clear, practical knowledge about the EU pharmaceutical regulatory framework, the changes underway, and how these developments will affect their work.

Conference methodology

The conference will begin by exploring the pillars of the existing framework, highlighting the regulatory successes in promoting patient safety and innovation, while also addressing the structural deficiencies that require reform. Subsequent sessions will provide a deep dive into the legislative proposals presented by the Commission, evaluating their legal architecture and intended impact. A hallmark of the conference is the platform it provides for key stakeholders – national regulatory authorities, the pharmaceutical industry, patient advocacy groups, and legal experts – to express their views on the reform and assess its implications from their professional perspectives.