ESTRI gateway

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An Electronic Standards for the Transfer of Regulatory Information (ESTRI) Gateway is a data exchange standard to support official communication in the area of drug approval / drug monitoring .

definition

An ESTRI gateway is compliant with the recommended core standards. The various drug authorities such as the European Medicines Agency (EMA), the German Federal Institute for Drugs and Medical Devices (BfArM), the Japanese Ministry of Health, Labor and Social Affairs (MHLW) or the American Food and Drug Administration (FDA) implement this complex Standards to be able to exchange information with other parties, especially from the pharmaceutical industry . The data exchange is independent of the technical infrastructure on both sides. The FDA calls their ESTRI Gateway Electronic Submissions Gateway (ESG) today.

The ESTRI Gateway Standard was developed by the ICH working group M2 .

content

In terms of content, the ESTRI Gateway addresses the following aspects:

  • Physical media
  • File format ( XML , SGML )
  • Data exchange of information ( AS1 , AS2 , AS3 standard)

The requirements for completing the data fields of ICSRs ( Individual Case Safety Reports or suspected adverse drug reactions ) and SUSARs ( Suspected Unexpected Serious Adverse Reactions or suspected cases of unexpected serious side effects of an investigational drug ) are specified in the ICH ICSR DTD Version 2.1.

Individual evidence

  1. ↑ PDF ( Memento from March 4, 2016 in the Internet Archive )
  2. ↑ http://www.fda.gov/ESG/
  3. ↑ Archive link ( Memento from December 27, 2008 in the Internet Archive )

Web links