Editorial - Post-marketing surveillance – Monitoring, technovigilance and pharmacovigilance
Vigil Sanit Debate, Rio de Janeiro, 2026, v.14: e02602| Published on: 2026-02-04
DOI:
https://doi.org/10.22239/2317-269X.02602Keywords:
Vigilância pós-comercialização, Monitoramento, Tecnovigilância, FarmacovigilânciaAbstract
This section of the Visa in Debate Journal will present evidence to support post-marketing surveillance of regulated technologies, such as medicines, food, medical devices (equipment, materials for use in health and in vitro diagnostics), results of strategic studies produced in cooperation between the Oswaldo Cruz Foundation Brasília (Fiocruz Brasília) and the National Health Surveillance Agency (Anvisa). This cooperation aims to produce evidence that can support the regulatory decision-making process and, as a teaching and research institution, Fiocruz Brasília has an interest in disseminating the results from the studies.
________________________________________________________________
1 PROJETO GEREB-005-FIO-21 “Support for actions for the development of regulation and health surveillance".
Downloads
References
1. Agência Nacional de Vigilância Sanitária – Anvisa. Monitoramento pós-mercado. Boletim Informativo Vigipós vol. 4. dez 2022[acesso 16 set 2024].Disponível em: https://www.gov.br/anvisa/pt-br/centraisdeconteudo/publicacoes/monitoramento/boletinsmonitoramento-pos-mercado/boletim-monitoramento-4oedicao-2022.pdf
2. Melchior SC. Vigilância pós-comercialização de produtos para saúde: questões sobre organização, gestão e implantação no Sistema Nacional de Vigilância Sanitária [tese]. Rio de Janeiro: Fundação Oswaldo Cruz; 2020[acesso 16 set 2024]. Disponível em:https://arca.fiocruz.br/handle/icict/46211
3. Silva RE, Amato AA, Sousa T,Carvalho MR, Novaes MRCG. The patient’s safety and access to experimental drugs after the termination of clinical trials: regulations and trends. Eur J Clin Pharmacol. 2018;74:1001-10.https://doi.org/10.1007/s00228-018-2474-9
4. Harrison RK. Phase II and phase III failures: 2013-2015. Nat Rev Drug Discov. 2016;15(12):817-8.https://doi.org/10.1038/nrd.2016.184
5. Fleming TR, DeMets DL, Roe MT, Wittes J, Calis KA, Vora AN et al. Data monitoring committees: promoting best practices to address emerging challenges. Clin Trials. 2017;14(2):115-23.https://doi.org/10.1177/1740774516688915
Downloads
Published
Issue
Section
Categories
License
Copyright (c) 2026 Health Surveillance under Debate: Society, Science & Technology
This work is licensed under a Creative Commons Attribution 4.0 International License.
COPYRIGHT ALLOWANCE The author (s) hereinafter designated as the ASSIGNOR hereby assign and transfer, free of charge, the ownership of the copyrights related to this ARTICLE to the Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Health Surveillance under Debate: Society, Science & Technology) – Visa em Debate, represented by FUNDAÇÃO OSWALDO CRUZ, established at Av. Brasil, nº 4365, Manguinhos, Rio de Janeiro, RJ, Brazil, CEP 21045-900, under the conditions set out below: (a) The terms and conditions set forth in this Agreement shall apply to the following: 1. The ASSIGNOR declares that they s(he) is (are) the author (s) and owner (s) of the copyrighted property of the ARTICLE submitted. 2. The ASSIGNOR declares that the ARTICLE does not infringe the copyrights and / or other property rights of third parties, that the disclosure of images (if any) has been authorized and that they s(he) assume(s) full moral and / or property liability for its content, before third parties. 3. THE ASSIGNOR assigns and transfers all copyrights relating to the ARTICLE to the ASSIGNEE, especially the rights of editing, publication, translation into another language and reproduction by any process or technique. The ASSIGNEE becomes the exclusive owner of the rights related to the ARTICLE, and any reproduction, totally or partially, is prohibited in any other means of publicity, printed or electronic, without prior written authorization from the ASSIGNEE. 4. The assignment is free and, therefore, there will be no remuneration for the use of the ARTICLE by the ASSIGNEE.
