Proposal of regulatory framework for Advanced Therapy Medicinal Products in Brazil

Introduction: Advanced Therapy Medicinal Products (ATMP) have been a therapeutic promise for the treatment of several diseases, including those for which there is no therapeutic alternative available on the market. These products, obtained from human cells, were categorized internationally as a new therapeutic class with similar approach as biological medicines, although with different criteria, due to their peculiarities. Objective: This article aims to describe the history of the discussions and regulations published for the thematic, and to present the perspectives related to the development of the Brazilian regulatory framework for this new category of product, with the objective of providing a stable and transparent regulatory environment, favorable to the technological development at national level, as well as to attract national and international investments in the field. Method: The development of this article was based on the research of the history of normative published about the topic, on the regulatory initiatives implemented by Anvisa as well as on the participation of the authors in forums and discussions towards the theme. Results: Basis of the national regulatory framework for PTA to be elaborated, and exposure of the main aspects of the proposal. Conclusions: The proposal of regulatory framework for ATMP will cover the regulations for evaluation and approval of clinical trials by Anvisa, Certification of Good Cell Practices for producer establishments and marketing authorization of products.