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Compliance In Focus
Posted by John Lehmann on Fri, Apr 18, 2014

Should THIS be the Next Global Priority?

Should THIS be the Next Global PriorityBack in 2012 an article was published in PLOS titled “Strengthening Medical Product Regulation in Low- and Middle-Income Countries” which strongly suggests developing countries must become a global health priority. In fact, The World Health Organization (WHO) recognizes regulatory system functions as one of the six core building blocks of health systems.

There exists an essential value of medical product regulatory systems in regulatory domains such as:

  • Global product supply chains
  • Clinical trials
  • Premarket approval
  • Post-market surveillance
  • Regulatory science

Despite this fact, many emerging countries have little attention focused on this important building block. The article points out that “few global initiatives focus on strengthening low- and middle-income country medical product regulatory systems.” Should this become a global priority? As stated in the article:

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.

It’s important to note that this request comes with challenges. As noted, “There are numerous competing priorities for political and financial support, especially in the wake of the global financial crisis” but the need for increased regulatory function must remain as a growing priority.

Check out the article which is full of valuable points, case studies, and references on this topic. Do you think these low- to middle-income countries need to provide incentives and more sustainable economic development before this can become a global priority?

Let us know your thoughts.

Photo Credit: duke.roul

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Topics: Global Priority, World Health Organization, Regulatory Systems


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