Regulatory Frameworks for Radiotheranostic Devices across Major Jurisdictions: A Systematic Review and Meta-Analysis

Radiotheranostic devices are combination products that integrate both diagnostic imaging and therapeutic functions using targeted radionuclide therapy, allowing accurate care from diagnosis to therapy and follow-up. This study systematically evaluates existing regulations for radiotheranostic devices in the United States (US), Europe (EU), Australia, India, Japan, Singapore, and China with the aim of identifying gaps and areas for standardization. This systematic review was carried out using the PRISMA methodology, systematically searching PubMed, Google Scholar, and Scopus databases for peer-reviewed publications and regulatory documents from January 2018 to March 2024. Articles and documents related to radiotheranostic device regulation were extracted and analyzed to determine regulatory differences between them. Both the US and EU had relatively well-organized regulatory frameworks and had defined approval processes while India, China, and others showed evolving regulatory processes. Differences included dosimetry standards, complexities of approval involving various government agencies, requirements for clinical trials, manufacturing standards, and quality management systems. This diversity has led to significant challenges in terms of device approval time and accessibility. Regulatory differences pose serious barriers to global harmonization and hinder access to patients. Implementation of standard coordination strategies such as development of standardized protocols and quality management systems will help achieve harmonization.