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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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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909