Name and Organisational Changes at ICH

For 25 years we’ve known ICH to be the International Conference on Harmonisation. That, however, is no longer the case! Since October 2015, ICH is officially called the International Council for Harmonisation. A strategic name change that does not change the abbreviation, however does mark the organisational changes1 that have happened within the organisation.

ICH has, in it’s 25 year existence, developed over 60 Guidelines on Quality, Safety, Efficacy and Multidisciplinary topics, in addition to products including Electronic Standards for the Transfer of Regulatory Information (ESTRI), the Common Technical Document (CTD & eCTD), and the Medical Dictionary for Regulatory Activities (MedDRA).

We’ve gotten to know the organisation as being a joint effort of three regions, the US, the EU and Japan to harmonise regulation around the development of pharmaceutical products. Regulators, research based industry and other parties from those regions, like the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) 2 as well as the World Health Organisation (WHO)3 made up the steering committee of ICH.

ICH in it’s new form has officially become a Swiss legal entity with an assembly as the over-arching governing body. The first assembly added the Swiss and Canadian regulators to the steering committee and has opened the door to other regulators around the world to join ICH. Besides the regulators, ICH has declared that there are also possibilities for the inclusion of other global industry sectors to join ICH. As they state: “the reforms strengthen ICH as the leading platform for global pharmaceutical regulatory harmonisation, and one that brings together in a transparent manner all key regulatory authorities and industry stakeholders.”4

Current ICH membership includes the following 5 regulators: Health Canada (Canada), European Commission (EU), Ministry of Health Labor and Welfare/Pharmaceuticals and Medical Devices Agency (Japan), Swissmedic (Switzerland), Food and Drug Administration (USA). It also includes the following 3 industry members: European Federation of Pharmaceutical Industries and Associations (EU), Pharmaceutical Research and Manufacturers of America (USA) and Japan Pharmaceutical Manufacturers Association (Japan).


Your GCP Nerd

GCP Nerd is a blog about ICH GCP in particular and related clinical research topics. If there are any topics or questions you’d like Your GCP Nerd to address, feel free to mail them to: GCP Nerd.

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