How early regulatory strategy, data governance, and sustainability can turn collaboration into lasting Impact
In today’s rapidly evolving healthcare landscape, collaboration alone is no longer enough. To deliver real impact – especially in the regulatory space – multi-stakeholder projects must embed regulatory thinking, data governance, and sustainability from day one. That’s the central message of a new paper published on June 16, 2025, in Nature Reviews Drug Discovery by the Innovative Health Initiative (IHI) and the Critical Path Institute (C-Path). Rather than treating regulatory engagement as an afterthought, the authors lay out a forward-thinking blueprint for transforming consortium-based research into meaningful regulatory outcomes that accelerate patient access to innovation. Their approach places regulatory engagement, robust data standards, and sustainability planning at the heart of a project from the very beginning, an effort to tackle the longstanding structural hurdles that often slow down drug development. Many in the industry have welcomed the initiative as a step in the right direction.Â
Yet, even as the paper offers a roadmap for smarter, more effective collaboration, it also highlights a persistent challenge: in Europe, systemic barriers—fragmented processes, slow adoption of regulatory tools, and inconsistent incentives—continue to undermine progress. There’s a growing sense of caution among experts who point out that Europe’s regulatory framework still lags behind more agile and innovation-oriented models in the U.S. and Japan. Over the past two decades, global consortia involving academia, industry, regulators, and patient groups have tried to break through the same barriers. But as the paper makes clear, true success lies not just in collaboration itself, but in embedding regulatory science at the core of project lifecycles – from day one.
Difficulties in the European regulatory landscape
EFPIA analysis shows that European drug approval timelines still trail those of the U.S., Japan, Canada, and Australia, weakening Europe’s competitiveness in bringing innovation to patients. 
Although EMA’s Regulatory Science Strategy and EFPIA’s Regulatory Road to Innovation outline reforms, such as regulatory sandboxes and streamlined committee processes, to foster agility and responsiveness, many companies remain concerned about slow implementation and uneven access to expedited pathways like PRIME or phased review.
Positive momentum meets structural barriers
The proposal from IHI and C-Path has sparked positive discussions in Europe’s pharmaceutical and regulatory communities. Stakeholders have commended the initiative for clearly defining regulatory considerations and encouraging collaboration across different sectors. On the other hand, there’s growing recognition that some underlying problems in the European regulatory framework, such as complexity, inconsistency, and limited flexibility, may still hinder the full potential of these efforts.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has expressed support for the general direction of the EMA’s regulatory science strategy, especially in fostering innovation and improving patient access to medicines. EFPIA has emphasized the importance of broader uptake and consistent application of accelerated pathways like PRIME, increased use of real-world data (RWD), and greater regulatory predictability to make Europe more competitive in global drug development. However, this support comes with reservations.
Concerns over incentives, implementation, and data use
EFPIA is worried about the legislative changes to the EU pharmaceutical package, especially the proposal to shorten regulatory data protection (RDP) from 10 years to 8 years.
They argue this change could decrease Europe’s attractiveness for investment in research and development, especially for small and medium-sized enterprises and the biotech sector. EFPIA estimates that, without adequate incentives, Europe could lose up to a third of its global share of pharmaceutical R&D investment by 2040. The federation has described the Commission’s proposal as a «missed opportunity» that could weaken intellectual property protections and slow down innovation.
Broader stakeholder perspectives on data, access, and transparency
EFPIA has also raised specific technical objections to elements of the reform. Critics argue that these adjustments may further diminish the incentives for investing in therapeutic areas that are already commercially vulnerable. Additionally, EFPIA has expressed concern that overly rigid environmental criteria in the proposed legislation could delay or prevent the availability of essential medicines.
European stakeholders, including public health NGOs and patient organizations, have expressed some concerns alongside the industry. The European Patients’ Forum (EPF) advocates for greater patient involvement in decision-making and improved clarity in post-marketing studies and disease registries. In response to EMA’s Regulatory Science Strategy, many also stressed the continued importance of solid clinical trial evidence. While real-world data is noticed as a valuable resource, there’s concern about relying on it too heavily. Stakeholders believe that real-world data (RWD) should enhance essential safety and efficacy evaluations, especially for new or high-risk treatments. They argue that RWD should complement traditional studies, not replace them.
What these contrasting viewpoints make clear is a deeper underlying challenge: even when consortium-led projects like those from IHI and C‑Path succeed in streamlining internal workflows and improving coordination among partners, they’re still bound by a wider European regulatory environment that is itself in flux, and not always ready to absorb or apply the outcomes of such initiatives fully. As such, even the most carefully designed consortia may struggle to deliver regulatory impact if broader systemic issues—such as inconsistent implementation, regulatory uncertainty, and insufficient incentives for innovation, are not also addressed.
Opposing views
The IHI/C-Path approach is praised, but critics point out limitations. Regulatory fragmentation among EU member states may restrict evidence frameworks, and resource constraints at the EMA and national authorities could slow reviews, even with early engagement. Uneven uptake of expedited pathways (e.g., PRIME) may limit benefits to only select consortia or high-profile projects. Such critiques highlight the risk that consortium‑level initiatives may deliver regulatory tools, but not necessarily translate these into faster approval or broader access within current EU structures.
Turning a consortium’s work into something regulators can use requires more than just good science: it needs careful planning and the right digital tools. The IHI and C-Path paper stresses that regulatory thinking must be built into the project from the start, not added at the end. This means defining a regulatory roadmap early on: deciding which agencies to involve, what kind of evidence they will need, and how to collect and share it in a usable format. Tools like data standards (e.g., CDISC) and FAIR principles (Findable, Accessible, Interoperable, Reusable) help ensure that data is properly organized and ready for regulatory review.
One practical example of this is C‑Path’s RDCA‑DAP platform – a secure, cloud-based data environment built on Aridhia’s Digital Research Environment (DRE). This tool lets consortium partners upload, organize, and analyze clinical data in a way that meets regulatory expectations. It also supports controlled access, so regulators can review the data without compromising privacy or data integrity. Planning for long-term sustainability is essential. After the end of a project, it’s necessary to confirm that the data, and tools developed during the project, stay accessible for research, industry, or regulatory compliance. We need to create governance structures, clarify data ownership rules, and develop platforms that support these resources after funding ends.
Key challenges and proposed solutions
For over two decades, global consortia have identified several fundamental challenges that must be addressed to achieve real regulatory impact. Engaging with regulators earlier and in an organized way is essential for aligning task goals with regulatory expectations, which helps to prevent expensive setbacks later. Establishing clear standards for evidence is crucial to ensuring data quality during regulatory reviews. Data governance enhances scientific reliability by ensuring that data remains accessible and reusable throughout the drug development process. Planning for long-term sustainability guarantees that tools and knowledge remain available after the project ends, creating a roadmap to turn collaborative research into regulatory value.
The Nature Reviews paper delivers a compelling, actionable framework for how consortia can design projects with regulatory uptake in mind, anchored in four strategic pillars. However, success ultimately depends on broader systemic reforms in Europe, including the timely and uniform implementation of EFPIA’s Regulatory Road to Innovation and EMA’s Strategy to 2025.
Turning collaboration into real change
The IHI and C‑Path paper offers a compelling vision of how multi-stakeholder consortia can become powerful drivers of regulatory progress – if they are strategically designed from the outset. Embedding regulatory thinking into the very foundation of collaborative projects, aligning evidence generation with agency expectations, ensuring data is well-governed and usable, and planning for sustainability are no longer optional ambitions – they are essential conditions for success. With the evolution of the European regulatory landscape, even the best-designed initiatives can fail if systemic barriers such as legal uncertainty, inconsistent implementation, and diminished incentives for innovation are not addressed. The transition from isolated innovations to real impact approaches requires more than just good ideas: it needs sustained political commitment, collaboration across sectors, and a regulatory culture that is as agile and forward-thinking as the science it aims to support.
References:
Brumfield, M. A., Higson, G. C., Ollivier, C., & Seigneuret, N. (2025). Delivering regulatory impact from consortium-based projects. Nature Reviews Drug Discovery.
