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Compliance In Focus
Posted by Stephani Hulec on Wed, Jun 11, 2014

Regulations in a Flat World

Regulations in a Flat WorldThe World Health Assembly is the decision-making body of the World Health Organization (WHO). This assembly draws leading government health officials from the 194 WHO member nations and was first convened in 1948 shortly after the WHO was created. On 24 May 2014, the 67th annual World Health Assembly closed.  This close marked the end to a five day meeting that featured a record-breaking number of agenda items, documents and resolutions, and almost 3,500 registered delegates. During the assembly more than 20 resolutions on important global public health issues were adopted.  These adoptions ranged from issues relating from antimicrobial drug resistance and access to essential medicines to addressing the global challenge of violence and the public impact of exposure to mercury and mercury compounds. Of note, is the passage of a resolution to strengthen regulatory systems.

Co-sponsored by Australia, Brazil, Colombia, Mexico, Nigeria, South Africa, Thailand, and the United States, this resolution endorses a “comprehensive approach to strengthening medical product regulation” in order to “improve the regulation of medical products globally and ensure that medical products are of assured quality.” This involves a future progressive transition of prequalification to networks of strengthened regulatory authorities and a promotion of collaboration and within regulatory systems. One of the leaders of the Assembly Session leading to passage of this resolution was FDA commissioner Dr. Margaret Hamburg.  She, along with the Mexican Secretary of Health, Dr. Mercedes Juan Lopez led a panel that included the South African Director General of the Department of Health; the Executive Director of The Global Fund to Fight AIDS, Tuberculosis and Malaria; the Assistant Director-General of the World Health Organization; and the Senior Regulatory Officer of the Bill and Melinda Gates Foundation.  Together this panel highlighted the challenges and opportunities to the ever changing landscape of an increasingly global supply of medical products. As Dr. Hamburg wrote in a recent FDA blog, discussion at this session “focused on the critical role that regulators play in ensuring access to lifesaving medical products by creating an environment of good regulatory practices…”

As collaboration and convergence of regulatory systems among various nations continues to increase it will be interesting to see what impact, if any, this plays on regulatory approval of medical devices between different countries.  Currently, approval of a device can vary greatly between different countries although simultaneous studies can potentially narrow this gap. In an increasingly flat world, international collaboration is essential and a strengthened regulatory system should be a solid foundation for safe, quality, and effective medical products for global use. 

Photo Credit: Tim Morgan

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Topics: Medical Devices, World Health Organization, World Health Assembly, Regulations

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