Tecnologia organ-on-a chip: verificação do cenário global da aplicabilidade no contexto regulatório de produtos farmacêuticos

Introduction: Traditional preclinical studies using animals may not accurately reflect the efficacy and safety of compounds in humans. Therefore, the search for alternative methods and predictive strategies that offer advantages in terms of reliability, cost reduction, and ease of diffusion and adoption by laboratories is of great relevance, as well as ethical issues surrounding the use of animals. In this context, “organ-on-a-chip” (OoC) technology has been proposed as one of the alternatives to the use of laboratory animals. Although OoC technology is on the path to becoming widely accepted as a specific platform for preclinical research for human application and therapeutic testing, challenges and limitations remain to its regulatory acceptance. Objective: To address the technology’s applicability and regulatory acceptance by comparing Brazil with the United States of America (USA) and the European Union (EU) based on registered patent applications, a literature review, and data from official websites. Method: Data was collected through searches in the CAPES portal of journals, the PatentScope database managed by the World Intellectual Property Organization (WIPO), the websites of regulatory agencies, companies that commercialize OoC, societies discussing this technology, and the TSAR tool. Results: Patents related to the fields of microfluidics, OoC, and microphysiological systems (MPS) have been filed. It was observed that pharmaceutical companies are evaluating and applying this technology, indicating that the market is likely to grow, although this technology is not yet included in official regulatory acceptance guidelines. Conclusions: These results demonstrate the potential to overcome the limitations of current models. However, to promote the inclusion of OoC as a globally recognized predictive method, mobilizing universities, industries, research centers, financial support institutions, and regulatory bodies in a collaborative effort is essential, combining scientific knowledge, regulatory guidelines, and investment in research and training.