Editorial - Technological innovation and health regulation

Vigil Sanit Debate, Rio de Janeiro, 2026, v.14: e02658| Published on: 2026-05-04

Authors

  • Flavia Tavares Silva Elias Author
  • Margarete Martins Oliveira Author
  • Maria Gloria Vicente Author
  • Stela Candioto Melchior Author
  • Viviane Cassia Pereira Author

DOI:

https://doi.org/10.22239/2317-269x.02658

Keywords:

Technological Innovation, Health Regulation

Abstract

This section of the Visa in Debate magazine presents evidence produced by strategic studies, the result of cooperation between the Oswaldo Cruz Foundation Brasília (Fiocruz Brasília) and the National Health Surveillance Agency (Anvisa), with the purpose of supporting the regulatory decision-making process.

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References

1. Organisation for Economic Co-operation and Development – OECD. Manual de Oslo: proposta de diretrizes para coleta e interpretação de dados sobre inovação tecnológica. 3a ed. Paris: Organisation for Economic Co-operation and Development; 2004.

2. Sounderajah V, Patel V, Varatharajan L, Harling L, Normahani P, Symons J et al. Are disruptive innovations recognised in the healthcare literature?A systematic review. BMJ Innov. 2021;7(1):208-16.https://doi.org/10.1136/bmjinnov-2020-000424

3. Agência Nacional de Vigilância Sanitária - Anvisa. Portaria Nº 1.484, de 15 de dezembro de 2025. Aprova a agenda regulatória da Anvisa para o biênio 2026-2027.Brasília: Anvisa; 2025[acesso 15 fev 2026]. Disponível em: https://www.gov.br/anvisa/pt-br/assuntos/regulamentacao/agenda-regulatoria/agenda-2026-2027

4. Darrow JJ, Avorn J, Kesselheim AS. FDA Regulation and Approval of Medical Devices: 1976-2020. JAMA. 2021;326(5):420-32.https://doi.org/10.1001/jama.2021.11171

5. Warraich HJ, Tazbaz T, Califf RM. FDA Perspective on the regulation of artificial intelligence in health care and biomedicine. JAMA. 2025;333(3):241-7.https://doi.org/10.1001/jama.2024.21451

6. Joshi G, Jain A, Araveeti SR, Adhikari S, Garg H, Bhandari M. FDA-approved artificial intelligence and machine learning (ai/ml)-enabled medical devices: an updated landscape. Electronics. 2024;13(3):1-15.https://doi.org/10.3390/electronics13030498

7. Wasiullah P, Yadav P, Yadav S, Yadav P, Yadav R. Pharmaceutical regulatory agencies and organization around the world scope and challenges in drug development. Int J Pharm Res Appl. 2025;10(1):2765-9.https://doi.org/10.35629/4494-100227652769

8. Balakumar P, Mulukuri NVLS, Jagadeesh G. A map of molecular drug targets and therapeutics for the US FDA-approved drugs: The impact of expedited regulatory pathways and first-in-class drug approvals on drug innovation. Pharmacol Ther. 2026;277:108945.https://doi.org/10.1016/j.pharmthera.2025.108945

9. Gomase VS, Sharma R, Dhamane SP. Global analysis of regulatory frameworks and drug safety standards in the drug approval process. Curr Drug Saf. 4 set 2025.https://doi.org/10.2174/0115748863392869250827042742

10. Kuveria H, Patel Z, Raval M, Zaveri M. Overview and lifecycle management of generic pharmaceutical drugs in Mexico, Guatemala and Brazil. Int J Drug Regul Aff. 2024;12(2):67-76. https://doi.org/10.22270/ijdra.v12i2.676

11. Fonseca EMD. Reforming pharmaceutical regulation: a case study of generic drugs in Brazil. Policy Soc. 2014;33(1):65-76.https://doi.org/10.1016/j.polsoc.2014.03.004

12. Ribeiro AA, Acosta A, Pontes MA, Machado Beltran MA, Peixoto RT, Leite SN. Transparency of data on the value chain of medicines in Argentina, Brazil, and Colombia. Front Pharmacol. 2023 Jan 5;13:1-18.https://doi.org/10.3389/fphar.2022.1063300

13. Agência Nacional de Vigilância Sanitária - Anvisa. Resolução RDC Nº 1.014, de 30 de janeiro de 2026. Institui o sandbox regulatório para produtos de cannabis medicinal.Diário Oficial União. 3 fev 2026.

14. Agência Nacional de Vigilância Sanitária - Anvisa. Portaria Nº 124, de 6 de fevereiro de 2026. Institui o comitê de acompanhamento regulatório da inovação em saúde no âmbito da Agência Nacional de Vigilância Sanitária (Anvisa). Diário Oficial União. 10 fev 2026.

15. Gadelha CAG. Complexo econômico-industrial da saúde: a base econômica e material do Sistema Único de Saúde. Cad Saúde Pública. 2022;38:1-17.https://doi.org/10.1590/0102-311X00263321

Published

2026-05-04

Issue

Section

TECHNOLOGICAL INNOVATION

Categories

How to Cite

Editorial - Technological innovation and health regulation: Vigil Sanit Debate, Rio de Janeiro, 2026, v.14: e02658| Published on: 2026-05-04. (2026). Health Surveillance under Debate: Society, Science & Technology , 14, 1-3. https://doi.org/10.22239/2317-269x.02658

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