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Enabling an Accelerated Development Path for Chlorhexidine Digluconate Gel 7.1% w/w for the Prevention of Omphalitis

British Journal of Pharmacy

University of Huddersfield Press

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      In 2012, the United Nations (UN), identified chlorhexidine as a Life-saving Commodity and called for the development of a chlorhexidine product suitable for the prevention of omphalitis (umbilical cord infection) in developing countries. In response, GlaxoSmithKline (GSK) set out to develop a chlorhexidine digluconate 7.1% w/w gel, in partnership with Save the Children. The vision was to develop a gel which could pass a stringent regulatory review thereby assuring a safe, effective, and quality product. Review under the European Medicines Agency’s (EMA) Article 58 pathway was pursued, with accelerated assessment granted. The regulatory dossier compiled literature-based evidence for clinical efficacy and safety, supplemented by GSK-generated in-vitro studies and a full CMC data package to support the quality. No new clinical trial data or in vivo non-clinical study data were submitted. A positive opinion from the EMA was received in 2016. The time from the initial UN call to EMA Positive Opinion was 3 years and 7 months.

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      British Journal of Pharmacy
      University of Huddersfield Press
      January 12 2017
      January 12 2017
      : 2
      : 2
      © 2017

      This work is licensed under a Creative Commons Attribution 4.0 Unported License. To view a copy of this license, visit



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