How can Belgium combine safety, quality and regulatory rigour with the agility needed to accelerate radiopharmaceutical innovation and patient access?
Belgium has many of the ingredients needed to be a leading European hub for nuclear medicine: strong scientific and clinical expertise, important production capabilities and an established life sciences ecosystem. Yet as radiopharmaceutical therapies and diagnostics evolve at pace, having strong capabilities alone is not enough.
The ability to translate innovation into clinical development, manufacturing and ultimately patient access increasingly depends on how effectively the different parts of the ecosystem work together.
This will be at the heart of the session “Regulatory Excellence as a Driver of Innovation” at the BioWin conference on Nuclear Medicine in Belgium on 15 October 2026, moderated by Ingrid Maes, Managing Director of Inovigate.
The discussion will bring together regulatory, nuclear safety, clinical and industry perspectives around one central question: how can Belgium accelerate the development and deployment of innovative radiopharmaceuticals while maintaining the highest standards of safety and quality?
A complex innovation pathway
Nuclear medicine sits at the intersection of several regulatory and operational frameworks. Pharmaceutical regulation and GMP requirements need to interact with nuclear safety and radiation protection requirements, while hospitals must have the infrastructure, processes, expertise and capacity required to conduct clinical trials and ultimately deliver new treatments to patients.
Each requirement exists for a valid reason. The challenge arises when these requirements are experienced by innovators and clinical centres as separate steps within what is, in practice, one continuous innovation pathway.
For radiopharmaceutical developers, the question is therefore not simply whether regulatory standards are high. It is whether requirements are sufficiently clear early in development, whether different processes are effectively sequenced and whether innovators can plan with sufficient predictability.
This distinction matters. Regulatory excellence should not be seen as the opposite of agility. Done well, it can create the clarity and confidence needed for companies to invest, initiate clinical development and bring innovation to patients.
From regulatory complexity to regulatory predictability
One important theme of the discussion will therefore be identifying where avoidable friction occurs.
For a hospital preparing an innovative radiopharmaceutical clinical trial, regulatory requirements can converge with questions around local infrastructure, staffing, contracting and operational readiness. For industry, uncertainty at different stages of development can have consequences for timelines, costs and ultimately decisions on where clinical trials, manufacturing or other investments take place.
At the same time, authorities operate under distinct legal mandates and responsibilities. Creating a more coherent pathway does not mean blurring these responsibilities. Instead, there may be opportunities to strengthen early dialogue and coordination at the interfaces between stakeholders, helping innovators understand expectations before critical development decisions become fixed.
This shifts the debate from “How can we have less regulation?” to a much more relevant question:
How can we make a complex pathway more predictable, proportionate and coordinated without compromising its safety and quality objectives?
Regulatory excellence is also a question of competitiveness
The stakes extend beyond operational efficiency. Radiopharmaceutical development is increasingly international, and companies can compare different locations for clinical development, manufacturing and investment. Regulatory timelines, predictability, coordination and the readiness of clinical sites can therefore influence a country’s attractiveness for innovation.
Belgium starts from a strong position. The opportunity now is to consider how its expertise and capabilities can be complemented by an environment in which innovative companies can navigate the pathway with confidence.
That means moving beyond speed as the only measure of performance. Predictability can be just as important. Knowing what will be expected, when different interactions need to take place and how various requirements connect allows companies, hospitals and other stakeholders to plan more effectively.
In that sense, regulatory excellence itself can become part of Belgium’s competitive proposition.
Moving from challenges to practical solutions
Identifying friction is only useful if it leads to solutions. The BioWin discussion will therefore focus strongly on what could practically change.
Five areas merit particular attention:
- Earlier dialogue
Bringing the relevant expertise together earlier could help innovators anticipate requirements before major decisions and investments are made.
- Clearer expectations
Greater clarity around evidence, processes and timelines can improve predictability without changing underlying standards.
- Better coordination
Regulators, industry, hospitals and academia each see one part of the pathway. Better coordination at their interfaces can help make that pathway more coherent.
- Greater standardisation
Where differences between clinical sites or processes do not add value, harmonisation can reduce avoidable complexity and make Belgium easier to navigate for international developers.
- Shared learning
Innovative radiopharmaceuticals will inevitably raise new questions. Learning systematically from real cases can help the ecosystem adapt as technologies develop.
An important practical example is the proposed Belgian Clinical Trial Network for radioligand therapies. The initiative aims to create more harmonised and standardised procedures across participating hospitals and provide companies with a clearer entry point for initiating radiopharmaceutical clinical trials in Belgium.
Making excellence and agility reinforce one another
Perhaps the most important point is that Belgium does not have to choose between safety and innovation, or between regulatory excellence and agility.
The real opportunity lies in designing an ecosystem in which they reinforce one another.
Earlier dialogue can reduce rework. Better coordination can make complex requirements easier to navigate. Standardisation can remove variation that adds little value. Greater predictability can make Belgium more attractive for clinical trials and investment. And, ultimately, a better-functioning innovation pathway can help promising therapies and diagnostics reach patients sooner.
The question for Belgium is therefore ambitious, but highly relevant: could it become one of Europe’s most attractive places to develop and deploy innovative radiopharmaceuticals while continuing to uphold the highest standards of safety and quality?
Answering that question will require collaboration across the entire ecosystem.
On 15 October, Ingrid Maes will explore these issues with representatives from authorities, industry and clinical practice at the BioWin conference on Nuclear Medicine in Belgium in Namur.
Are you working on radiopharmaceutical innovation or navigating the regulatory, clinical, market access or implementation challenges surrounding nuclear medicine? Meet Ingrid Maes at BioWin or get in touch with us to continue the conversation.
Want to know more about this topic? Read our report “A radioligand therapy action plan for Belgium“.