ICH Takes Major Step Toward Increased Transparency, Expanded Governance

Posted 27 June 2013 | By Alexander Gaffney, RAC 

Global regulatory groups like the International Conference on Harmonisation (ICH) may be known for many things - guidelines, setting standards, and a convergence of regulations - but transparency isn't one of them. But now ICH says it has heard its critics and plans to make "more detailed information" regarding its ongoing and planned activities available to the public.


ICH is a pharmaceutical-focused regulatory harmonization group composed of regulators from the US, EU and Japan, and with additional participation from other regulators on a voluntary basis. Its goal is to set standards that apply in all member countries, allowing a company that plans to file in one country or region to be able to more easily file in multiple regions. Prior to the ICH, each region required a vastly different application and had different standards for required information, increasing the time and cost associated with obtaining a second or third regulatory approval.

But, as with many internationally-focused regulatory bodies, it can be difficult to keep track of what ICH is doing. Its meetings are spread out around the world, making it difficult to physically attend them, and are furthermore not webcast. Accordingly, unless you are able to attend them in person or find meeting minutes collected from an attendee, you're unlikely to get much insight into the particulars of a given meeting.

All that is due to start changing, albeit slowly, ICH said in a June 2013 statement regarding the outcome of its most recent meeting in La Hulpe, Belgium. The statement is typical by ICH standards-summary information condensed into several sentences that skims over any discussion, focusing instead on the outcome of a particular recommendation.

"The ICH SC has agreed to make more detailed information regarding the ongoing ICH activities available to the public," ICH wrote. "From now on, the agenda and the report of the Steering Committee (SC) meetings as well as the work plans of active expert working groups will be published on the ICH website. The ICH procedures and a set of slides summarizing their key elements will also be published."

"The ICH website will be updated to reflect these changes," ICH added.

Steering Committee Changes

In addition, ICH announced that its SC has been discussing further reforms to the organization, and it is set to adopt a new framework for governance, membership and decision making. "To promote greater involvement of global regulators, the ICH Global Cooperation Group (GCG) was successfully integrated into sessions of the ICH Steering Committee," it explained.

The GCG was once a subcommittee of the SC, and was formed in 1999 as a means to expand ICH's global impact beyond its three principal members. The GCG now includes a number of major regulatory bodies, including the Asia-Pacific Economic Cooperation (APEC), Association of Southeast Asian Nations (ASEAN), East African Community (EAC), Gulf Cooperation Council (GCC), Pan American Network for Drug Regulatory Harmonization (PANDRH) and the South African Development Community (SADC).

The changes appear to have the effect of greatly expanding the scope of global involvement in ICH, potentially paving the way for future expansion efforts.

The next ICH meeting is due to take place in Osaka, Japan on 9-14 November 2013.

ICH Statement

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