Medical Radionuclides and the UK Regulatory Framework: What the latest Regulatory Study means for Government and Innovators

The UK’s ability to secure a resilient supply of medical radionuclides is increasingly recognised as a matter of public health, industrial strategy and national resilience. Radionuclides underpin a wide range of diagnostic imaging and therapeutic treatments, yet their production and supply chains are complex, highly regulated and vulnerable to disruption.

Against this backdrop and acknowledging the importance of continued access to radionuclides for medicine, in December 2022, the Government launched the Medical Radionuclide Innovation Programme (MRIP). The MRIP focused on encouraging and funding innovation in technologies and techniques that could support access to radionuclides and increase resilience against global shortages, as well as building an evidence base to inform future decisions on radionuclide supply. 

As part of the MRIP, regulators were brought together to develop a better understanding of the roles and requirements of key radiological and civil nuclear safety regulatory bodies within the radiopharmaceutical supply chain and determine how new, innovative production methods would be regulated. Essentially, to assess whether the UK regulatory framework is fit to support emerging technologies and new domestic production pathways. 

The resulting UK Regulatory Study, published on 30 April 2026, provides the clearest articulation to date on how nuclear, radiological and environmental regulation applies across the radionuclide supply chain — and how that system should evolve to support innovation while maintaining safety and public confidence. 

This study is aligned with the principles behind the government response to the recently published Nuclear Regulatory Review 2025. It provides recommendations to examine regulatory processes in the UK, specifically in relation to medical radioisotopes, but which are relevant to the broader recommendations outlined in the regulatory review.

Three production scenarios were considered as part of the study: Electron Accelerator, Research Reactor and Harvesting from Legacy Waste. 

This article summarises the study’s key conclusions and its practical recommendations for Government and for developers seeking to bring new radionuclide production technologies to market.

The regulatory landscape: robust, but complex

A central finding of the MRIP regulatory study is that the UK already has a comprehensive and robust regulatory framework governing radiopharmaceuticals and medical radionuclides. Oversight is shared between multiple competent authorities, including the Environment Agency (EA) and devolved environmental regulators, the Office for Nuclear Regulation (ONR) and the Health and Safety Executive (HSE). Together, these bodies regulate different stages of the supply chain, from radionuclide production and waste management to workplace and public radiation protection, and vary depending on whether an activity is carried out on a nuclear licensed site or not. 

Importantly, the study does not identify any fundamental regulatory gaps or weaknesses that would prevent new radionuclide production technologies from being authorised in the UK. Existing legislation is considered sufficiently flexible to accommodate a wide range of technologies, including cyclotrons, accelerators and reactor‑based approaches, provided that applications are appropriately framed and supported by evidence. 

However, the study also highlights that the regulatory environment is intrinsically complex. Developers may need to engage with multiple regulators, each with distinct statutory remits, licensing regimes and information requirements. Without early coordination, this complexity can translate into uncertainty, delay and increased cost — particularly for novel technologies or for organisations with limited regulatory experience. 

Early engagement is a recurring theme throughout the report and the newly developed early engagement process for nuclear licensable activities (developed for new power reactor build) is referenced as an approach that could be used for novel nuclear licensable medical radionuclide production facilities.

A graded, risk‑based approach to regulation

One of the study’s most important conclusions is that UK regulators already apply, and are committed to developing further, a graded or proportionate approach to regulating medical radionuclide activities. This means that regulatory expectations should reflect the nature, scale and risk profile of the activity, rather than adopting a one‑size‑fits‑all model. This approach supports innovation while ensuring that high standards of safety and environmental protection are maintained.

For example, the study makes clear that for off‑site radionuclide production (and where no nuclear site licence is required) the relevant environmental regulator would regulate the keeping and use of radioactive materials as well as the accumulation and/or disposal of radioactive waste under comparatively lighter‑touch environmental permitting regime. 

Equally, regulators emphasise that they are willing to recognise international precedents, drawing on evidence from other “trusted” jurisdictions where similar technologies are already in operation.

The challenge is ensuring that this flexibility is understood, accessible and consistently applied in practice.

Key challenges identified by the study

While the study is broadly reassuring, it also identifies several systemic challenges that must be addressed if the UK is to move from innovation funding to operational delivery.

First, there is a risk of regulatory uncertainty for novel technologies and for the interpretation of target material (such as the definition of ‘nuclear matter’ and ‘excepted matter’), particularly where developers are unclear which regulator leads on which issues, or how the permitting, licensing and consenting regimes interact. This can be especially acute where environmental regulation intersects with nuclear safety. 

Secondly, regulators acknowledge potential capacity and capability pressures if multiple new production projects progress simultaneously. For example, if the UK were to pursue a large-scale medical radionuclide production programme. Although regulators consider themselves capable of regulating new technologies, increased demand will require early visibility, forward planning and sufficient resourcing. In particular, it is widely acknowledged that there is a national shortage of radiation protection expertise. The availability of specialist resource will be essential for the HSE’s ability to assess new radionuclide production facilities. 

Thirdly, the study notes that regulatory timelines can be a concern for developers operating in commercially or clinically time‑sensitive environments. While regulators do not commit to fixed timescales, they recognise the importance of predictable, transparent processes — particularly where innovation funding and investment decisions are contingent on regulatory progress.

Fourth, a common challenge to all production scenarios considered in the study is if the UK were to pursue a large-scale medical radionuclide production programme. This could result in centralised facilities both for production, but also potentially specialised medical settings for delivery of diagnostic and therapeutic uses. In turn this could lead to significant levels of discharge into the environment from one or a small number of places. In addition, increased availability of longer-lived, novel radionuclides may result in more hospitals needing to do more complex radiological assessments. This may in turn change the balance on what represents the Best Available Techniques (BAT) for controlling discharges into the environment and necessitate consideration of techniques such as abatement technologies, which to date have seen less consideration in non-nuclear licensed site settings such as hospitals.

Fifth, the study identifies the potential for novel technologies to interact with the Radiation (Emergency Preparedness and Public Information) Regulations, 2019 (REPPIR): sites with potential to cause a radiation emergency and their local authorities have duties to prepare emergency plans and make information available to the public; this would introduce financial and regulatory burden and could delay a site becoming operational. Whilst regulators did not identify any significant challenges that would prevent most of the scenarios presented in the study being brought to market, one exception may be the use of Th-228/Pb-212 generators, due to the anticipated quantity of Th 228 exceeding the REPPIR threshold for hazard evaluation and potentially requiring emergency plans and public information; this could constitute duties on hospitals, local authorities and the regulators.

Recommendations for Government: coordination, clarity and confidence

The study makes a series of practical recommendations aimed squarely at central government and policy‑makers.

• Strengthening cross‑regulator coordination is a consistent theme. While cooperation already exists, the study encourages more structured mechanisms for joint working, early engagement and shared understanding of novel technologies across regulators and jurisdictions. This is particularly important in a devolved regulatory landscape, where developers may otherwise face divergent approaches across the UK.
• The study recommends further work be done initially to explore the interface between the vires of ONR, HSE and the environmental regulators. This work should explore the interpretation of nuclear matter, excepted matter, isotopes and the requirement for nuclear site licensing. An example of where regulators could provide guidance is the designation of  target materials for accelerator production of radiopharmaceuticals; whether they are nuclear matter and excepted matter will determine which regulator has vires recognising there may be issues determining the origin of some target materials.
• As the proposals develop, the regulators recommend that HMG explore how the proposed radiopharmaceutical generator technology will interact with REPPIR (which is dependent on their design and proposed clinical use).
• The study also recommends that government provide clear strategic signalling on its long‑term objectives for radionuclide supply. Greater policy clarity would help regulators plan resource needs and enable developers to align investment decisions with anticipated regulatory and market conditions. 

Recommendations for developers: early engagement and regulatory literacy

For technology developers, research institutions and commercial partners, the study’s message is clear: regulation is navigable, but preparation is critical.

• Developers are strongly encouraged to engage with regulators at the earliest possible stage, even where technologies are still in development. Early dialogue allows regulators to understand the technology, identify the appropriate regulatory routes and flag information requirements before formal submissions are made.
• Developers are advised to make use of international evidence and precedent, particularly where technologies are already operating in comparable jurisdictions. Demonstrating that a technology is well‑understood and safely managed elsewhere can materially support the UK regulatory case.
• The EA notes that:
  • Discharges from centralised or co‑located facilities, particularly involving longer‑lived or novel radionuclides, may require more complex radiological assessments and could, in some cases, challenge dose constraints and restrict future operations. Early screening‑level dose assessments are therefore recommended to help identify potential impacts, inform appropriate mitigation measures, and assess whether discharge limits may constrain planned radionuclide production and use.
  • Novel radionuclides may lack empirical dose assessment values in existing models and in such circumstances typically use conservative values. The early identification of this by developers and the EA would help to enable work toderive more realistic values, leading to more realistic assessments and in turn helping to remove unnecessary constraints such as overly conservative discharge limits.
• The study emphasises the need for full life‑cycle consideration of all radioactive wastes and spent fuel as part of permit applications, including the identification of viable disposal routes. This is particularly important where novel radionuclides generate wastes with uncertain or constrained disposal options. Developers should therefore consider these issues early and, where necessary, take steps to enable any supporting work required to secure a permit from the EA.

Looking ahead: regulation as an enabler, not a barrier

Overall, the MRIP Regulatory Study presents a cautiously optimistic picture. It positions the UK regulatory framework not as a barrier to innovation, but as a potential enabler of a resilient, safe and trusted medical radionuclide supply. The challenge now is delivery – turning regulatory flexibility, coordination and engagement into practical outcomes that strengthen the UK’s health system and industrial capability.

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This article was written by Ian Truman and Victoria Barnes.