The FDA inspection for future registration of human use of Egaten worldwide

The FDA inspection for future registration of human use of Egaten worldwide




Tuesday 1 January 2019

Based on a successful conduct of a research study by Theodor Bilharz Research Institute (TBRI) team in collaboration with Swiss Tropical and Public Health Institute, the TBRI team was invited to actively participate in the FDA inspection for future registration of human use of Egaten worldwide

Based on the study entitled "Efficacy and Safety of Artemether in the Treatment ofChronic Fascioliasis in Egypt”: Exploratory Phase-2 Trials" conducted between TBRI team in collaboration with the Swiss Tropical and Public Health Institute (TPH), Basel, Switzerland.

Novartis Pharma AG, Basel, Switzerland asked for a primary reviewing of data from the United States Food and Drug Administration (USFDA) for future drug registration after the end of the company's duration agreement with WHO,2022. Representatives fromTBRI scientists who participated in the collaborative project ( involving Pharmacologists, Public Health Specialist and a Parasitologist )    paid a visit to the Swiss TPH to attend the FDA inspection of source data.

TBRI potential involving human power, facilities, equipment, international collaboration and salient activities were presented. Also, the source data was inspected by the FDA inspector. This is a step forward in the primary development of drug registration (Egaten®) for human use worldwide.