A Worldwide Overview of Regulatory Frameworks for Tissue-Based Products.

Abstract

Over the past decades, a wide range of tissue-based products (TBPs) have emerged as new therapeutic alternatives to conventional approaches, giving an opportunity to treat pathologies that have not been cured yet. TBPs are constituted by living/nonliving and genetically/nongenetically modified cells or tissues, which might be combined with materials that support their structure, molecules that favor the cellular environment, and even medical devices to create functional substitutes. These medicinal products are used for the repair, replacement, restoration, or regeneration of a damaged tissue in the patient. The clinical translation of these innovative products has led to the establishment of new and comprehensive regulatory schemes by regulatory bodies. The knowledge and adaptation to these regulatory shifts is essential for the pharmaceutical industries and academia, as it promotes the development of TBPs and their approval and marketing. TBPs follow different regulatory approaches depending on the jurisdiction in which the product is intended to be marked. The European Union and United States of America have developed a clear and specific regulatory pathway for TBPs. However, in other jurisdictions, the oversight of these products remains still challenging. This review describes and updates the main legal considerations, which must be implemented throughout the marketing authorization application process of a TBP, defining the regulatory framework of the main health agencies and outlining the major differences between them. Impact statement Tissue-based products (TBPs) are complex to regulate since many jurisdictions do not have an adapted legislation for these. Thus, researches may not consider crucial regulatory aspects during the development of these products, leading to failure for their marketing approval by regulatory bodies. This review describes how a TBP is overseen under several key jurisdictions and offers an overview of the steps that sponsors should follow until the product launch onto the market. Thus, this study provides guidance for nonexperts in regulatory affairs, boosting the understanding of the regulations governing these products, fasting, and easing the development of the same.