Literature DB >> 27706413

[Convergence of healthcare regulation in the Americas: history, development, and new challenges].

Ana Paula Jucá Silva, Patrícia Oliveira Pereira Tagliari.   

Abstract

The present article describes the changing relationship among healthcare regulatory authorities in various international settings, with special emphasis on the Americas. As other sectors, healthcare also faces the need to regulate international practices, while at the same time taking into consideration the specific realities of each country. Regulatory convergence - a movement towards technical alignment to enable the adoption of local regulatory mechanisms that take into account internationally recognized standards and principles to promote a single sanitary goal - has emerged as a means to address this challenge. Organizations that already use this tool, such as the International Conference of Drug Regulatory Authorities (ICDRA), Pan American Network for Drug Regulatory Harmonization (PANDRH), International Generic Drug Regulators Programme (IGDRP), and the International Medical Device Regulators Forum (IMDRF), among others, are currently working to gather knowledge, data, and specialists from different countries to build an international technical and scientific standard that can be used for decision-making by local regulators. This would ensure convergence of national regulations despite the need to adapt international standards to local needs, structure, and capacities. The most recent resolutions issued by the World Health Organization recognize the need to bring regulatory systems closer to the reality of national healthcare systems, and underscore the advantages of using existing local guidelines as input for cooperation with regulatory authorities.

Mesh:

Year:  2016        PMID: 27706413

Source DB:  PubMed          Journal:  Rev Panam Salud Publica        ISSN: 1020-4989


  4 in total

1.  Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries.

Authors:  Carlos E Durán; Martín Cañás; Martín A Urtasun; Monique Elseviers; Tatiana Andia; Robert Vander Stichele; Thierry Christiaens
Journal:  Rev Panam Salud Publica       Date:  2021-04-09

2.  The politics of COVID-19 vaccination in middle-income countries: Lessons from Brazil.

Authors:  Elize Massard da Fonseca; Kenneth C Shadlen; Francisco I Bastos
Journal:  Soc Sci Med       Date:  2021-06-02       Impact factor: 5.379

3.  Perspectives in the study of the political economy of COVID-19 vaccine regulation.

Authors:  Elize M da Fonseca; Holly Jarman; Elizabeth J King; Scott L Greer
Journal:  Regul Gov       Date:  2021-05-24

4.  Quality of medicines: Deficiencies found by Brazilian Health Regulatory Agency (ANVISA) on good manufacturing practices international inspections.

Authors:  Andrea Renata Cornelio Geyer; Varley Dias Sousa; Dâmaris Silveira
Journal:  PLoS One       Date:  2018-08-08       Impact factor: 3.240

  4 in total

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