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Regulatory Focus™ > News Articles > Health Canada, SwissMedic Join ICH as Steering Committee Members

Health Canada, SwissMedic Join ICH as Steering Committee Members

Posted 11 July 2014 | By Alexander Gaffney, RAC

Health Canada, SwissMedic Join ICH as Steering Committee Members

The International Conference on Harmonization (ICH), the influential international pharmaceutical regulatory harmonization body, has elected to add two new regulators to its Steering Committee, the group has announced.

In an announcement on 8 July 2014, ICH said Health Canada (HC) and Swiss regulator SwissMedic would both be joining its Steering Committee "in recognition of their historical involvement and commitment to ICH."

The Steering Committee, which previously only included members from the US, EU and Japan, is highly influential in all ICH activities. Per the ICH Proceduresdocument, the committee must endorse all proposed regulations. Any one member of the committee can derail a proposed regulation.

The Steering Committee is also responsible for appointing the MedDRA Management Board, which sets the standard for medical terminology used worldwide by regulators.

According to the ICH statement, the group is continuing to consider "a broader range of membership and governance reforms," though the direction of those reforms is not entirely clear from the statement.

In the same announcement, ICH also provided updates on several ICH guidances in development:

Document/Working GroupStatus
M7 EWG on Assessment and Control of DNA Reactive (mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic RiskReached Step 4
S5 Information Working GroupConcept Paper in Development
E6, Good Clinical Practices (GCP)Addendum in Development, Expected in June 2015
Q3D, Guideline for Elemental ImpuritiesStep 4 Expected in September 2014
Q7, Good Manufacturing Practice Guide for Active Pharmaceutical IngredientsQ&A Document in Development
M2, Electronic Standards for the Transfer of Regulatory InformationGroup Met
M8, Electronic Common Technical Document- eCTDReached Step 4m ICH eCTD specification 4.0 under development


ICH Statement

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