CLINICAL TRANSLATION OF TISSUE ENGINEERED MEDICINAL PRODUCTS

Tissue Engineering is a rapidly growing field with novel scientific concepts, new technological methods, and evolving regulatory policies for clinical translation. Most of the current basic regulations are taken from the pharma, bio-pharma, cell therapy with little modifications, and new inclusion for development of regulatory frame work for advanced therapeutic products. We propose to highlight the important concepts in the regulatory development for tissue engineered based medicinal products (TEMPs) without any compromise on Quality, safety and efficacy. Moreover, these evolving regulations should facilitate clinical transition to help large numbers of patients on conditionally or case-by-case basis, and accelerate the submission of on-line real-time safety and efficacy parameters. This review describes general regulations and its scientific concepts; specifically in the context of clinical translation for TEMPs. Importantly, this review highlights the need of regulatory development and support for sustenance of small and medium sized organizations without any compromise on safety and efficacy of the products. Furthermore, current clinical regulatory translational challenges and opportunities to articulate risk-benefit approaches by accessing its potential strength, efficacy or availability of standard therapy, safety of new product and its relevance's with TEMPs are discussed.