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Pharmaceuticals

EU Pharmaceutical Regulatory Reforms – Time to Consider Implementation Challenges and Opportunities?

Wednesday, May 14, 2025
08:30 - 09:30 CEST
Location: Copper Hall (level 0)
Learning Level: Advanced
Description: Current EU Pharmaceutical Regulatory Reforms include the General Pharmaceutical Legislation revision and HTA Regulation implementation while newly proposed legislation includes a Critical Medicines Act and a Biotech Act. These signal the continued focus on the EU’s life science sector by the European Commission. However, the road is often long between legislative text proposals to full implementation of framework changes. As the underpinning pharmaceutical legislation nears the trilogue discussion stage what can we learn from the implementation of related legislative updates? The draft texts introduce sweeping changes impacting the current 20 year old framework. This panel session will discuss the likely key changes that will be included in the final revision of the General Pharmaceutical legislation, and explore the question of when to begin to consider implementation?
Panellists from the EC, heath authorities, HTA bodies, academia, patient groups and industry will discuss what topics such as:
• Which provisions will have the biggest impacts on current ways of working?
• With the revision impacting the whole of the medicines lifecycle when and how should impacted stakeholders begin to undertake change management programs?
• What learnings can be taken from other medical product legislative updates to ensure a smooth implementation of GPL changes?
• How impacted stakeholders can work together to identify opportunities and challenges during the period of transition between legislative frameworks?

Learning Objectives:

  • Describe the key changes proposed in the EU revision of the pharmaceutical legislation
  • Define the implementation opportunities and challenges different stakeholders anticipate from proposed changes to the EU medicines’ regulatory system
  • Conduct an assessment of the impact that proposed changes would have on the development strategies for medicinal products and changes in EU focused regulatory affairs professional activities