FDA, EMA and PMDA Plot Harmonized Path for Antibiotics

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Regulators from the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), met in Tokyo last month to plot out an approach that would allow drugmakers to conduct a single development plan for new antibiotics.
The meeting, part of an ongoing effort by the three agencies to spur antibiotic development in light of growing concerns about antimicrobial resistance, was the third between the three agencies since 2016, with the goal of the effort being to align the agencies’ expectations for new products so that a single development program could satisfy regulatory requirements for all three jurisdictions.
Doing so would reduce the amount of duplicative work drugmakers would need to perform, potentially lowering the cost of development for certain antibiotics.
According to a summary of the meeting posted by EMA, the three regulators made “significant progress” in their discussions on clinical trial designs for antibiotic drugs for conditions such as uncomplicated gonorrhea and urinary tract infections.
The agencies were also in alignment on “the importance of adequately characterizing pharmacokinetic and pharmacodynamic relationships, particularly for drugs that are developed to address serious infections with unmet need.”
Additionally, the agencies agreed that studying antibiotics in pediatric patients is a priority and said they will look into ways to streamline pediatric antibiotic development.
The regulators plan to meet again in 2018 to continue their harmonization efforts.
EMA, Summary
Continue at: http://www.raps.org/Regulatory-Focus/News/2017/11/17/28907/FDA-EMA-and-PMDA-Plot-Harmonized-Path-for-Antibiotics/
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EIA – Laboratório de Metrologia e Aviónicos

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