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

De Angelis, Elena, Immins, L, Jibry, N, Hunt, D, Cheng, K, Chowdhury, P, Patel, C, Wilhelm, S and Williams, P (2017) Enabling an Accelerated Development Path for Chlorhexidine Digluconate Gel 7.1% w/w for the Prevention of Omphalitis. British Journal of Pharmacy, 2 (2). pp. 45-46. ISSN 2058-8356

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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.

Item Type: Article
Uncontrolled Keywords: chlorhexidine, gel, article 58, acceleration
Subjects: Q Science > Q Science (General)
R Medicine > R Medicine (General)
R Medicine > RS Pharmacy and materia medica
Schools: School of Applied Sciences
Depositing User: Megan Taylor
Date Deposited: 17 Jul 2018 12:09
Last Modified: 16 Jul 2019 08:00


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