Regulatory Focus™ > News Articles > ICH Looks to Increase Transparency of its Activities, Processes with New Procedures Manual

ICH Looks to Increase Transparency of its Activities, Processes with New Procedures Manual

Posted 04 September 2013 | By Alexander Gaffney, RAC

Within regulatory circles, one might argue the biggest trend in recent decades has been the shift toward global harmonization, with a large number of groups launching to help bring about a convergence of good regulatory practices resulting in benefits for both regulators and industry alike. But if a critique is present, it is that the processes by which this harmonization occurs can often be unnecessarily opaque, limiting the input of all but the most well-connected companies and entities.

Now one of the most prominent groups, the International Conference on Harmonisation (ICH), a pharmaceutical regulatory harmonization body consisting of regulators from the US, EU and Japan, is publishing new documents intended to explain in full detail exactly what goes on within its regulatory black box.


ICH first committed to increasing transparency in a June 2013 statement released on its website. The problem, Regulatory Focus noted at the time, is twofold:

  • ICH holds its meetings around the world, making it difficult to either attend meetings in person or designate a permanent liaison to attend meetings on your behalf in a particular city.
  • ICH does not release meeting minutes, transcripts or webcasts of its meetings.

The result is something of an opaque organization-far from a positive when its guidelines ultimately affect the pharmaceutical and biopharmaceutical industries of three of the most developed pharmaceutical markets on Earth.

Transparency, then, would stand to benefit industry greatly. And while one part of the ICH's transparency initiative is set to release more detailed information about ongoing ICH activities on a regular basis (including agendas, work plans and working group summaries), the other part of that process has to deal with how ICH functions.

ICH: The Definitive Guide

Now ICH is out with a new "Procedure" document intended to explain the entire ICH process from start to finish, most notably including the so-called "5-Step" process.

The extensive 82-page document also includes:

  • a glossary of common regulatory and ICH terms
  • definitions and explanation of common ICH activities
  • roles and responsibilities of all members of ICH steering committees and coordinators
  • a style guide meant to explain the word choices used in documents
  • document templates used by ICH

An overview presentation about the procedure document was also made available by ICH on its website.

ICH Procedure Document

Slide Presentation

ICH Press Statement

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