The European Medicines Agency (EMA) held the 16th Industry Standing Group (ISG) meeting on 28 April 2026, chaired by EMA's Head of Public and Stakeholder Engagement, to discuss the implementation of the revised EU pharmaceutical legislation. The meeting focused on simplifying, fostering innovation, and digitalizing the regulatory system, with industry stakeholders asked to submit their top 10 priorities by mid-May 2026. EMA will develop a roadmap based on these inputs.
The meeting covered key updates from the European Commission and EMA, outlining a two-year transition period with priorities on regulatory excellence, incentives, unmet medical needs, access, shortages, and antimicrobial resistance. Discussions also addressed shortage mitigation and prevention plans, vulnerability assessments for critical medicines, and the Union List of Critical Medicines. Progress on the European Shortages Monitoring Platform (ESMP) and harmonization of root cause terminology were noted.
Regulatory/HTA Interface and Data Quality Concerns
The regulatory/HTA interface under the HTA Regulation showed improved compliance for parallel processes. However, cross-industry concerns were raised about Product Management System (PMS) data quality, with a follow-up meeting planned to address these issues. The European Federation of Pharmaceutical Industries and Associations (EFPIA) presented its 'One Vision' proposal for modernizing the EU regulatory system.
Impact on Stakeholders
The revised legislation and its implementation will have significant impacts on several stakeholders:
- EU pharmaceutical industry: Faces a two-year transition period with new requirements for shortage mitigation, vulnerability assessments, and PMS data quality. While the legislation aims to foster innovation and simplify processes, industry must adapt to new compliance costs and reporting obligations. The 'One Vision' proposal indicates industry's push for a more efficient system.
- EMA and national competent authorities: Tasked with developing the implementation roadmap, managing the ESMP, and ensuring harmonization of root cause terminology. Increased workload and coordination demands are expected.
- Patients and healthcare providers: Stand to benefit from improved access to medicines and reduced shortages, but the transition period may cause temporary disruptions.
- EU taxpayers: Will fund the regulatory system's digitalization and monitoring platforms, potentially leading to long-term savings through more efficient processes.
Expected Follow-Up
EMA will develop a roadmap based on industry priorities submitted by mid-May 2026. A follow-up meeting on PMS data quality is planned. The ISG will continue to serve as a forum for collaboration between EMA, the European Commission, and industry to shape the future regulatory landscape.