Blog
About

  • Record: found
  • Abstract: found
  • Article: found
Is Open Access

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

Read this article at

ScienceOpenPublisher
Bookmark
      There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

      Abstract

      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.

      Related collections

      Author and article information

      Journal
      British Journal of Pharmacy
      BJPharm
      University of Huddersfield Press
      20588356
      January 12 2017
      January 12 2017
      : 2
      : 2
      10.5920/bjpharm.2017.31
      © 2017

      This work is licensed under a Creative Commons Attribution 4.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/

      Product

      Comments

      Comment on this article