1. International Council on Harmonisation (ICH)

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The European Commission recognised the economic burden of different national and regional requirements to MA applications, seen as an issue also by the regulatory authorities in the USA (Food and Drug Administration or FDA) and in Japan (Ministry of Health, Labour and Welfare, MHLW). In the early 1990s, the European Commission took the initiative to establish the International Conference on Harmonisation ICH http://www.ich.org/home.html in order to reduce the duplication of clinical trials and create a more streamlined regulatory assessment process for new applications. The first ICH conference took place in Brussels in 1991. In addition to regulatory authorities, industry organisations from the three regions participated in the conference (two more regions have been added since then, Canada and Switzerland). Finally, several observers joined the group.

In 2015 there was a need to expand the ICH scope from three, and later, five regions transforming it into a formalised global association. At the end of 2015 the ICH has changed to become the International Council for Harmonisation. The ICH Association is registered as a legal entity under Swiss Law. Their rules stipulate that the association establishes an ICH Assembly (https://www.ich.org/page/members). It retains the original acronym, ICH. The Assembly is open for more members than the original ICH.

A formal structure for collaboration is agreed. The primary goal for the ICH remains to elaborate (develop) and agree upon harmonised guidelines for medicines development and regulation. Such guidelines can considerably reduce the extra work imposed by different documentation requirements in the participating regions. A Management Committee (formerly a Steering Committee) controls the work.

The Management Committee consists of the following:

  • Regulatory Authorities
    • Europe - EU Commission (and the European Medicines Agency or EMA),
    • USA – FDA,
    • Japan – MHLW,
    • Canada, Health Canada,
    • Switzerland, Swissmedic,
    • eight further regional or national regulatory authorities elected by the ICH Assembly.
  • Observers
  • Support
    • ICH Secretariat.

One unique aspect of the ICH organisation is that industry participates formally in the Management Committee as well as in the work in general. This arrangement had never before existed nationally or regionally. In any case, the authorities still have the final say in any decisions.

There are four working groups doing the concrete work of elaborating ICH guidelines. The four groups each cover a specific area:

These groups work in areas covering several aspects of medicines development. As such, ICH has developed four sets of guidelines provided for the specific topics quality, safety, efficacy, and multidisciplinary (e.g. MedDRA, the Medical Dictionary for Regulatory Activities http://www.meddra.org/  which looks to provide standardised medical terminology, or the Common Technical Document -CTD- which are implemented by the regulatory authorities of its membership). For details, see section 4.2.