Comparative analysis of regulatory frameworks governing 3D printing of medicines: an international review and implications for France

Background
3D printing of medications represents a breakthrough for personalized therapy in hospitals, making it possible to tailor doses, release profiles, and dosage forms to the patient’s needs. However, its implementation is hindered by the lack of a specific regulatory framework. In France, the laws governing hospital-prepared medications do not define the status of 3D-printed medications. The objective is to compare the regulatory frameworks of different countries in order to draw lessons for France.

Method
A literature review was conducted on the regulatory frameworks and literature of five countries: the United States, the United Kingdom, Spain, Belgium, and the Netherlands. The analysis was structured around nine criteria: legal classification, legal basis, authorization system, allocation of responsibilities, traceability, validation, batch release, pharmacovigilance, and gray areas.

Results
None of the countries studied has a specific legal status for 3D-printed drugs; each country classifies them under its existing categories. In the United States, depending on the context, they fall under marketing authorization, compounding, or clinical trials, as the Food and Drug Administration published recommendations in 2025 that include 3D printing. The United Kingdom is the only country to have established a legislative framework dedicated to point-of-care manufacturing that can incorporate 3D printing. Spain relies on compounded medications within its clinical trial regulations and conducted the first European pediatric clinical trial using 3D-printed tablets. Belgium and the Netherlands are incorporating 3D printing into their compounding regulations with strengthened guidelines; the Netherlands is adopting adapted good manufacturing practices that align closely with what the UK proposes in its regulations. The European Medicines Agency, through the Quality Innovative Group, is beginning to establish recommendations on printing intermediates that would help define a precise framework for authorized production.

Conclusion
With its 2023 best practices for preparation, France has a solid foundation for integrating 3D printing into hospital pharmacy operations. The findings support the classification of pharmaceutical printers and inks as critical components. Care must be taken to distinguish this from industrial manufacturing, and to that end, collaboration at the European level could be beneficial.

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