ICH Archive

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has evolved, through its ICH Global Cooperation Group, to respond to the increasingly global face of drug development, so that the benefits of international harmonisation for better global health can be realised worldwide. ICH's mission is to achieve greater harmonisation to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner.

ICH Files

E2A

Updated on 11 November 2011

  • Definitions and Standards for expedited safety reporting from clinical trials
  • Version: 27 October 1994

E2B R2

Updated on 11 November 2011

  • Data elements for electronic transmission of individual case safety reports
  • Version: 5 February 2001

E2B R3 DRAFT

Updated on 31 December 2011

  • Draft E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification (version3.01)
  • Version: 3.01 16 June 2011

E2C R1

Updated on 11 November 2011

  • Guideline on Periodic Safety Update Reporting
  • Version: 6 November 1996 and amended November 2005

E2C R2 Step 2 Draft

Updated on 16 March 2012

  • The E2C(R2) draft Guideline has been released for consultation under Step 2 of the ICH process in February 2012.
  • Version: E2C R2 Step 2

E2D

Updated on 11 November 2011

  • Definitions and standards for expedited reporting of post approval adverse events
  • Version: 12 November 2003

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