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. native to reconstructive bio-surgeries. These innovative therapies are made available to potential patients in timely manner. Figure 1: General process map and characterization of TEMPs: Overview of process from cell sourcing to IMP Production and intermediate bank/ biomaterial qualification steps. Critical components for characterization are at six corners of hexagonal i.e., identity, potency, purity, safety, stability and viability demonstrate the quality and efficacy of process and product. Related techniques for each critical characteristics were displayed in box. Abbreviations: ID-Infectious diseases; IMP-Investigational Medicinal Products; MCB-Master cell bank; TEMP-Tissue Engineered medicinal products; WCB-Working cell bank.The TEMPs are combinations of cells and regenerative matrices, which involves the bioengineering approaches to engraft the biomaterial and cells to retain the tissue-level functions. The unique natures of the products are being convergent to traditional regulatory process for safety and efficacy evaluations. Understanding the regulatory requirements and meeting to reach the evolving regulatory expectation of TEMP during the transition period is even more difficult for start-up entrepreneurs or small companies in early stage of clinical trials. Further vast requirements on product development and pre-clinical data within defined time frame makes developers to evolve various adaptation strategies to complete clinical transitional phase of TEMPs. On the other hand, significant reduction in development time for acellular TEMP for tropical applications were expected [4,5] . Further, cell secretome of cell culture co...