Posted 11 July 2014
By Alexander Gaffney, RAC
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:
|M7 EWG on Assessment and Control of DNA Reactive (mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk||Reached Step 4|
|S5 Information Working Group||Concept Paper in Development|
|E6, Good Clinical Practices (GCP)||Addendum in Development, Expected in June 2015|
|Q3D, Guideline for Elemental Impurities||Step 4 Expected in September 2014|
|Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients||Q&A Document in Development|
|M2, Electronic Standards for the Transfer of Regulatory Information||Group Met|
|M8, Electronic Common Technical Document- eCTD||Reached Step 4m ICH eCTD specification 4.0 under development|