The FDA, EMA and PMDA have been engaged in discussions since 2016 regarding convergence on New Drug Application for antimicrobial drugs addressing the public health threat presented by antimicrobial resistance. The discussions aim at bringing harmonization in regulations related to clinical studies conducted for novel antimicrobial drugs (antibacterial and antifungal) across USA, Europe and Japan.

A recent discussion was organized in Q4, 2019 that covered key aspects of antimicrobial drug development including antifungal agents, pediatric development of anti-infective drugs, identify differences in test methods across all three regions and criteria for susceptibility testing. The discussion also explored considerations by three health authorities related to clinical trial for monoclonal antibodies for treating or preventing infectious diseases.

FDA-EMA Pediatric Collaboration

An FDA-EMA Pediatric collaboration is in place to enhance the pediatric investigation plan (PIP) by EMA and pediatric study plan (PSP) by FDA. The current efforts on convergence and harmonization aim to bring such collaboration across three health authorities to enhance multi-regional anti-infective medicine development.


Next discussion in this direction is planned in 2020 that will bring the cross-border collaboration closer to bringing harmonized regulations that enable countries to accept clinical study data from these countries for anti-infective drugs under investigation. This effort will not only provide enhanced scientific and clinical opinion on INDs (investigational new drugs), increase chances of success/approval and reduce time to market for companies developing therapies.

GRP’s iCRMAX Platform

Global Regulatory Partners’ iCRMAX (integrated Clinical Regulatory and Market Access) Platform enables drug development companies to reduce their time to market for INDs by providing a harmonized global clinical and regulatory strategy across USA, EU, Japan, China and Brazil.

To discuss about your new drug development programs, please write to us at info@globalregulatorypartners.com 

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