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Healthy Skepticism Library item: 20436

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.


Publication type: Journal Article

Preston C, Valdez M, Bond K
Strengthening Medical Product Regulation in Low- and Middle-Income Countries
PLoS Med 2012 Oct 23; 9:(10):


Summary Points
Few global initiatives focus on strengthening low- and middle-income country medical product regulatory systems.
However, globalization and the scaling up of medicines and vaccines to the developing world are highlighting the urgent need for systems to assure product efficacy, safety, and quality.
This article explores case studies in regulatory domains such as global product supply chains, clinical trials, premarket approval, post-market surveillance, and regulatory science to demonstrate the essential value of medical product regulatory systems to low- and middle-income countries.
Here, a viable path is put forward for making this important topic a global health priority.
Introduction Top
Medical product regulatory systems are central to health systems; they ensure high quality and safe interventions like drugs, vaccines, and medical devices for patients who need and count on them. The World Health Organization (WHO) recognizes this fact and includes regulatory system functions as one of the six core building blocks of health systems: access to medical products, vaccines, and technologies of assured quality, safety, and efficacy [1].

Although WHO has recognized their importance, to date, little attention has been focused on regulatory systems in low- and middle-income countries. They have not featured prominently in global health and development assistance programs, and few strategic documents of major global health initiatives, including the United States Global Health Initiative, reference regulatory systems [2].

The global activities that do involve regulatory systems typically involve high-income countries. For example, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), which harmonizes regulatory standards and processes for the pharmaceutical industry, includes regulatory authorities from the European Union, Japan, and the United States [3]. The membership of the International Medical Device Regulators Forum is similarly comprised, including Australia, Canada, the European Union, Japan, and the United States. Brazil is the only low- or middle-income country that is a member [4].

The lack of attention to medical product regulatory systems in low- and middle-income countries is a significant gap that needs to be bridged.


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