Horizon scanning helps EMA and the European medicines regulatory network understand, anticipate and prepare for scientific and technological change.
It supports the network in identifying emerging innovations that may affect medicines development, regulation, manufacturing or patient access.
By detecting these developments early, the network can prepare for future regulatory challenges, support responsible innovation and help ensure that patients in Europe can benefit from safe, effective and innovative therapies.
EMA and the European medicines regulatory network identify emerging scientific and technological signals from a range of sources, including clinical trials, patents, scientific publications, technology reports, research funding calls and stakeholder interactions.
Experts review and prioritise the signals for further analysis.
The EU IN explores selected topics through horizon scanning reports that assess the current landscape, identify potential regulatory challenges and opportunities, and recommend actions.
The EU-IN horizon scanning reports provide strategic insight into emerging areas of science and technology relevant to medicines regulation.
They support early preparedness by outlining the scope of each topic, its potential impact on medicines development and patient access, and the actions that may be needed across the network.
As with all EU-IN Horizon Scanning reports, these reports identify areas where greater regulatory preparedness can support innovation.
They help the European medicines regulatory network to:
More information:
Targeted protein degradation is an emerging therapeutic approach already treating patients, that removes disease-causing proteins rather than simply inhibiting them.
The report highlights regulatory considerations for quality, safety, clinical development and EU competitiveness.
Microgravity environments are being explored for their potential to support medicines development, including biological modelling, crystallisation, formulation research and future manufacturing applications.
The report identifies regulatory considerations for quality, comparability, manufacturing control and long-term preparedness.
Radiopharmaceuticals are radioactive medicinal products used for both diagnostic and therapeutic purposes, with growing relevance in areas such as oncology, imaging and theranostics.
The report highlights regulatory needs around harmonised guidance, long-term safety evidence, multidisciplinary expertise and secure manufacturing and supply chains.
Engineered living materials (ELMs) combine living cells and biomaterials to create systems capable of producing or releasing therapeutic substances in situ.
The report considers regulatory classification and development needs, including quality, manufacturing, non-clinical, clinical and biosafety considerations.
Nanotechnology is enabling new approaches to targeted delivery, controlled release and advanced medicinal product design.
The report highlights regulatory needs around classification, characterisation, safety assessment and harmonised standards for nanomedicines.
New approach methodologies (NAMs) offer opportunities to improve human relevance in medicines development while supporting replacement, reduction and refinement of animal testing.
The report highlights regulatory steps needed to support their acceptance, including clearer terminology, evidence standards and early engagement.
Alzheimer’s disease remains an area of high unmet medical need, with rapid developments in biomarkers, diagnostics and disease-modifying treatments.
The report examines scientific and regulatory challenges and identifies actions to support earlier diagnosis, clinical development and regulatory preparedness.
Faecal microbiota transplantation is being developed mainly for recurrent Clostridioides difficile infection, with broader microbiome-based applications under investigation.
The report identifies regulatory priorities for donor screening, traceability, product quality, clinical evidence and long-term safety monitoring.
Genome editing offers the potential for long-lasting treatments by making targeted changes to the human genome, particularly for diseases with high unmet medical need.
The report highlights regulatory considerations around quality, delivery systems, on- and off-target effects, long-term follow-up, classification and ethics.
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17 July 2026