Three-dimensional printing of medicines: Challenges and regulatory perspectives
Vigil Sanit Debate, Rio de Janeiro, 2025, v.13: e02445 | Published on: 23/10/2025
DOI:
https://doi.org/10.22239/2317-269X.02445Keywords:
Three-dimensional Printing, Medicine, Food Legislation, Health Regulation, RegulatoryAbstract
Introduction: The application of three-dimensional printing technology (3DP) has gained notoriety as an alternative to the traditional manufacturing model in the production of medicines, enabling the development of personalized medicines for each patient. Objective: To consolidate the currently available information regarding the regulatory perspectives on the use of 3DP in pharmaceutical manufacturing and to discuss the challenges that must be addressed to enable its broad adoption. Method: This work consists of an integrative literature review in the National Library of Medicine (PubMed) and Web of Science covering the period from December 2019 to December 2024, which approaches the regulatory basis that guide the application of 3DP in the medicine production, in comparison with the traditional production methods, and what are the main gaps and challenges associated with these regulations. Results: The evaluated articles highlight the need of establishing specific regulations focused on the quality and manufacturing sites of medications produced by 3DP, to enable their adoption as an option for supplying personalized medicines. The results reported in this review show that the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Medicines & Healthcare products Regulatory Agency (MHRA) have adopted monitoring of new technologies and advising institutions as a way of enabling the introduction of these medicines in the market and prepare new regulations. Conclusions: The information in this article serves as a preliminary basis to understand the existing regulatory challenges in relation to 3DP of medicines and provide a vision of the scenarios that are being proposed for this technology insertion.
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Author Biographies
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Rodrigo Fonseca da Silva Ramos, Instituto de Tecnologia em Fármacos (Farmanguinhos), Fundação Oswaldo Cruz (Fiocruz), Rio de Janeiro, RJ, Brasil
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Beatriz Borges Correa, Instituto de Tecnologia em Fármacos (Farmanguinhos), Fundação Oswaldo Cruz (Fiocruz), Rio de Janeiro, RJ, Brasil
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Amanda de Oliveira Esteves Moreira, Instituto de Tecnologia em Fármacos (Farmanguinhos), Fundação Oswaldo Cruz (Fiocruz), Rio de Janeiro, RJ, Brasil
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Alessandra Lifsitch Viçosa, Instituto de Tecnologia em Fármacos (Farmanguinhos), Fundação Oswaldo Cruz (Fiocruz), Rio de Janeiro, RJ, Brasil
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Jorge Carlos Santos da Costa , Fundação Oswaldo Cruz (Fiocruz), Rio de Janeiro, RJ, Brasil
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