International Regulators Call for Action on Antimicrobial Resistance

Regulatory NewsRegulatory News | 05 August 2019 |  By 

The International Coalition of Medicines Regulatory Authorities (ICMRA) on Thursday issued a statement calling on industry, healthcare practitioners, researchers and other global health leaders to address the growing threat of antimicrobial resistance (AMR).
ICMRA says it supports the World Health Organization’s (WHO) efforts on the matter, and notes that WHO has called AMR “one of the top ten threats to global public health [and] threatens our ability to treat even the most minor infections.”
To address the issue, ICMRA says a “One Health” approach championed by the WHO is needed, involving stakeholders at all levels of public health, including media organizations, which ICMRA says keep the public aware of the issue.
As part of that approach, ICMRA calls on industry to increase investment in research and development for antimicrobial medicines and diagnostics and says healthcare practitioners must do their part by using antimicrobials appropriately, following WHO’s AWaRe decision-making tool.
ICMRA also says that healthcare leaders should work with industry to develop approaches to addressing the economic challenges of developing and marketing antimicrobials.
“There are unique challenges facing development, commercialization and viability of products that tackle AMR, and there is a need for modern regulatory systems that can adapt to these needs,” ICMRA says, noting that regulators should work to streamline regulatory requirements for antimicrobials.
ICMRA emphasizes that regulators should develop processes to facilitate the review of new products such as phage therapies and point-of-care diagnostics that could provide new tools in the global armamentarium against infectious diseases.



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