Literature DB >> 33478590

Making the investment case for national regulatory authorities.

Gloria Twesigye1, Tamara Hafner1, Javier Guzman2.   

Abstract

Well-functioning national regulatory authorities (NRAs) ensure access to safe, effective, quality-assured, and affordable medical products. However, the benefits of their work are often unseen and difficult to attribute, thereby making NRAs undervalued and under-resourced, particularly in low- and middle-income countries. This paper offers three key arguments NRAs and other stakeholders can use to advocate for greater investment in regulatory systems strengthening-medical products regulation effectively safeguards public health; effective regulation improves health system's efficiency by increasing access to affordable medical products, contributing to universal health coverage; and robust regulation strengthens local pharmaceutical manufacturing and bolsters pharmaceutical trade. NRAs' critical role in health systems is indisputable, yet they need to better promote their value to receive the requisite resources to function effectively.

Entities:  

Keywords:  Access to medicines; Health systems strengthening; National regulatory authorities; Quality-assured medicines; Regulatory systems

Year:  2021        PMID: 33478590      PMCID: PMC7818051          DOI: 10.1186/s40545-021-00299-7

Source DB:  PubMed          Journal:  J Pharm Policy Pract        ISSN: 2052-3211


  6 in total

1.  Regionalization as an approach to regulatory systems strengthening: a case study in CARICOM member states.

Authors:  Charles Preston; Harinder S Chahal; Analia Porrás; Lucette Cargill; Maryam Hinds; Babatunde Olowokure; Rudolph Cummings; James Hospedales
Journal:  Rev Panam Salud Publica       Date:  2016-05

2.  Optimized Medical Product Regulation in Mexico: A Win-Win for Public and Economic Health.

Authors:  Mikel Andoni Arriola Peñalosa; Ricardo Cavazos Cepeda; Mario Alanis Garza; Murray M Lumpkin
Journal:  Ther Innov Regul Sci       Date:  2017-05-05       Impact factor: 1.778

3.  Switching from originator brand medicines to generic equivalents in selected developing countries: how much could be saved?

Authors:  Alexandra Cameron; Aukje K Mantel-Teeuwisse; Hubert G M Leufkens; Richard Ogilvie Laing
Journal:  Value Health       Date:  2012-07-11       Impact factor: 5.725

Review 4.  Essential medicines for universal health coverage.

Authors:  Veronika J Wirtz; Hans V Hogerzeil; Andrew L Gray; Maryam Bigdeli; Cornelis P de Joncheere; Margaret A Ewen; Martha Gyansa-Lutterodt; Sun Jing; Vera L Luiza; Regina M Mbindyo; Helene Möller; Corrina Moucheraud; Bernard Pécoul; Lembit Rägo; Arash Rashidian; Dennis Ross-Degnan; Peter N Stephens; Yot Teerawattananon; Ellen F M 't Hoen; Anita K Wagner; Prashant Yadav; Michael R Reich
Journal:  Lancet       Date:  2016-11-08       Impact factor: 79.321

5.  Integrating pharmaceutical systems strengthening in the current global health scenario: three 'uncomfortable truths'.

Authors:  Tamara Hafner; Marlon Banda; Jillian Kohler; Zaheer-Ud-Din Babar; Murray Lumpkin; Mojisola Christianah Adeyeye; Emmanuel Nfor; Francis Aboagye-Nyame; Javier Guzman
Journal:  J Pharm Policy Pract       Date:  2020-06-25

6.  Prevalence and Estimated Economic Burden of Substandard and Falsified Medicines in Low- and Middle-Income Countries: A Systematic Review and Meta-analysis.

Authors:  Sachiko Ozawa; Daniel R Evans; Sophia Bessias; Deson G Haynie; Tatenda T Yemeke; Sarah K Laing; James E Herrington
Journal:  JAMA Netw Open       Date:  2018-08-03
  6 in total

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