A Worldwide Overview of Regulatory Frameworks for Tissue-Based Products

• Published in: Tissue engineering. Part B, Reviews Reviews, 2020-04, Vol.26 (2), p.181-196
• Main Authors: Oberweis, Caroline Veronique, Marchal, Juan Antonio, López-Ruiz, Elena, Gálvez-Martín, Patricia
• Format: Article
• Language: English
• Subjects: Legislation; Marketing; Medical equipment; Pharmaceutical industry; Review Article; Tissue engineering
• ISSN: 1937-3368; 1937-3376
• DOI: 10.1089/ten.teb.2019.0315

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.