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.

Advances in spray products for skin regeneration

“…Based on whether the skin spray is made up of cells or not, its regulatory pathway to be marketed will be different. The acellular skin sprays are classified as medical devices [ 162 , 163 ]; and the cellular skin sprays, as advanced therapy medicinal products (ATMPs) [ 164 ]. Thus, the appropriate categorization of skin sprays is critical since it will define the specific requirements to be met and, therefore, the applicable rules governing their commercialization.…”

“…Both types of skin sprays must be manufactured under Good Manufacturing Practice (GMP) guidelines [ 166 , 167 ]. The data that should be provided in the authorization request for each type of skin spray will depend on its classification and its jurisdiction [ 164 ]. Thus, the regulatory framework of two of the main jurisdictions is described below: European Union (EU) and USA.…”

“…The main characteristics of these types of products are that they must be made up of living cells (autologous, allogeneic or xenogeneic), and in addition, they might incorporate other components such as biomaterials, signaling molecules, non-viable cell derivatives, etc. [ 164 , 181 ].…”

Tissue Engineering in Musculoskeletal Tissue: A Review of the Literature

“…These depend on the nation in which they are intended to be marketed [200]. Currently, only 12 tissue-based products have been authorized worldwide [201] (Table 5).…”

Risk Management

“…Quality risk management (QRM) is a tool recognised and incorporated in mandatory and voluntary accreditation schemes, GMP being the strictest standard in this regard [8]. GMP is of mandatory application in drug manufacturing and, therefore, they are also applied to substantially manipulated cell-based products, which are considered medicines by most regulatory authorities [6,9]. QRM is in fact the adaptation of the topic Q9 from the guidelines issued by the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use.…”