Abstract
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.
Highlights
Tissue engineering is an interdisciplinary technology that combines the principles of life science, biomaterial engineering and clinical applications
Despite rapid progress in the tissue engineering application, there are no specific regulatory/mechanisms to provide a legal framework for introducing new or bio-similar like tissue engineering product into clinical practice[1]. This has resulted in slow approvals for tissue engineered based medicinal products (TEMPs), besides; expensive industrial regulatory approaches were introduced as essential regulatory requirements, in addition to various the social and ethical clearances[2]
There is need for the fast track approvals to test this innovative medicine to access in clinical trial based on risk-benefit ratio to the patients, as well as considering various factors such as availability and usability of existing standard therapy, cost, and economics
Summary
Tissue engineering is an interdisciplinary technology that combines the principles of life science, biomaterial engineering and clinical applications. The recent advances in interdisciplinary science enables for process and product characterization (Figure 1), and develop innovative TEMPs that restore repair and regenerate the cells, tissues to retain and improve biological function. These TEMPs have potential to revolutionize the medical treatment to improve the quality-of-life to patients, where there are no standard therapies available or available treatments are expensive. The extent of comprehensiveness in product characterization program minimize the risk that are likely to be associated for new innovative products and increase safety, quality, efficacy and consistency in clinical out-come
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