As Europe revises its General Pharmaceutical Legislation (GPL), the innovative pharmaceutical industry welcomes the ambition to modernise our regulatory framework. This is a once-in-a-generation chance to build a system that not only protects patients but also strengthens Europe’s resilience, accelerates access to new treatments, and secures our global leadership in health innovation. While some proposals represent real progress, others must be refined to ensure the framework delivers on Europe’s strengths and potential.

What the evidence shows
A recently published study assessed the GPL proposals for a future EU regulatory framework across seven domains of competitiveness: robustness, patient centricity, predictability, speed, agility, efficiency, and innovator support. The findings show a mixed picture: some measures – such as regulatory sandboxes and faster assessment times – would enhance agility, speed, and support for innovation. Others, however, could unintentionally limit the framework’s effectiveness if not adjusted.

These include the complexity of providing scientific support for combination products (drug-device/diagnostic/companion diagnostic), a lack of flexibility in utilising different types of evidence such as Real-World Evidence, and the exclusion of marketing authorisation holders from labelling decisions when the data is generated by regulators or third parties.

Getting these provisions right is essential. With the right balance, the GPL can help Europe attract investment, accelerate innovation, and deliver new medicines for patients. But the GPL revision alone will not be enough to build a truly competitive system. This is an opportunity not just for incremental progress, but to transform the way medicines are developed, authorised, and made available to patients.

Implementation matters – and it opens the door to more
How the revised legislation is implemented will be critical in shaping its impact. Effective implementation can help unlock the GPL’s potential, but Europe can go further. To create a world-class regulatory system, Europe must also look beyond the GPL. By aligning the GPL with the Biotech Act and the Innovation Act, we have the opportunity to create a truly world-class regulatory environment: one that fosters investment, encourages innovation, and improves patient access.

A new mindset for a new era
To succeed, the EU Medicines Regulatory Network, industry, and stakeholders need to adopt a new mindset for regulatory cooperation. This means moving beyond incremental change and embracing ways of working that are more collaborative, more science-driven, and digitally enabled.

The EFPIA vision points the way forward: a regulatory system that is adaptive and integrated, technology-enabled and science-based – providing seamless, end-to-end oversight of medicines and combined products, and giving patients faster access to innovation.

Delivering this vision will require paradigm changes so that the EU:

• Attracts investment through strong intellectual property protections.
• Accelerates innovation by modernising oversight of clinical trials.
• Improves patient access through better recognition of value.
  
  

A call to policymakers and regulators

The GPL revision is an important step forward – but Europe’s real opportunity is to set a new course for the next decade. As work begins on the EU Medicines Regulatory Network strategy beyond 2028, policymakers should use this moment to align the GPL with the Biotech Act and the Innovation Act, while embedding truly agile, science-based approaches.

Europe already has the science, the talent, and the ambition. What is needed now is the collective will to turn these strengths into a competitive edge. By acting boldly, we can create a regulatory framework that not only delivers for patients but also secures Europe’s leadership in global health innovation for decades to come.


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NOTE: This blog is based on the research article “Innovative industry perspective: Assessing the proposed regulatory changes and their impact on innovation and competitiveness of the EU regulatory framework as part of the EU General Pharmaceutical Legislation revision” by Eskola et al., available online as pre-proof before print, in Drug Discovery Today.

Opinions expressed in this blog are made in Sini Eskola's personal capacity and cannot be associated with the official position of Takeda nor University of Utrecht.