Regulatory considerations for animal studies of biomaterial products.

ABSTRACT

Animal studies play a vital role in validating the concept, feasibility, safety, performance and efficacy of biomaterials products during their bench-to-clinic translation. This article aims to share regulatory considerations for animal studies of biomaterial products. After briefly emphasizing the importance of animal studies, issues of animal studies during biomaterial products' translation are discussed. Animal studies with unclear purposes, flawed design and poor reporting quality could significantly reduce the translation efficiency and create regulatory challenges. Regulatory perspectives on the purpose, principle, quality and regulatory science of animal studies are also presented. Animal studies should have clear purposes, follow principles of 3R+DQ (replacement, reduction, refinement, design and quality) and execute under an efficiently operating quality management system. With the advancement of regulatory science, National Medical Products Administration of China has been developing a series of standards and guidance documents on animal studies of medical devices. Case studies of making decisions on whether to conduct animal studies are provided in the end with drug-eluting stents as examples. In summary, animal studies of biomaterial products should pay close attention to the rationale, design and quality in order to achieve their purposes.