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Initiation of Harmonisation Action
Suggestions for new harmonisation initiatives may arise in a number of fora, including: ICH Regional Guideline Workshops; other regional and international conferences, workshops and symposia dealing with R&D and regulatory affairs; recognised Associations, Federations and Societies which represent scientific and technical professionals concerned with the development, testing and registration of medicines. Formal proposals for ICH action must, however, be channelled through one of the six parties to ICH or one of the ICH Observers on the Steering Committee.
ICH Concept Paper
The Concept Paper is the trigger of all ICH harmonisation activities. This provides a short summary of the proposal (maximum 2 pages) and provides the information indicated below:
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Type of Harmonisation Action Proposed: (e.g., a new harmonised tripartite guideline/recommendation, or a revision of an existing guideline - indicating the category of procedure);
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Statement of the Perceived Problem: Brief description with an indication of the magnitude of the problems currently caused by a lack of harmonisation, or - in the case of new scientific developments - anticipated if harmonisation action is not taken;
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Issues to be Resolved: A summary of the main technical and scientific issues, which require harmonisation;
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Background to the Proposal: Further relevant information, e.g., the origin of the proposal, references to publications, discussions in other fora;
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Type of Expert Working Group: Recommendation on whether the EWG (if needed) should be a six-party group - for topics related to the R&D of new drug substances and products - or an extended EWG - for topics with implications beyond new drug research.
If necessary, further documentation and reports may be annexed to the Concept Paper.
Endorsement by the Steering Committee
A Concept Paper is normally submitted to the ICH Steering Committee by an ICH party or an Observer. The Steering Committee takes the following points into account when discussing a Concept Paper:
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Objectives and Expected Outcome of the harmonisation action;
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Categories of ICH process;
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Composition of the EWG or IWG appointed to discuss the technical issues;
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Setting a Timetable and Action Plan for the EWG/IWG.
The Concept Paper may need to be revised and updated to reflect the Steering Committee discussion and conclusions. The Steering Committee may also request the development of a Business Plan.
ICH Business Plan
The Business Plan, whose template was adopted at the Washington meeting in June 2004, should be submitted to the Steering Committee upon request.
Concept papers will be developed and proposed by one of the ICH parties (including Observers) for initial consideration by the Steering Committee. At this initial stage a Business Plan will not be required although one may be provided at the discretion of the proposing party. If the Steering Committee agrees that a topic may warrant further consideration and a Business Plan has not been provided and agreed, an informal EWG / IWG will be formed and the informal group will work through e-mail, teleconference and, exceptionally, face-to-face meetings. The first tasks of the informal EWG / IWG will be to finalize a Concept Paper and develop and agree a Business Plan. The revised Concept Paper and Business Plan will be sent prior to and presented at the next SC teleconference or face-to-face meeting.
Establishment of an ICH Working Group
Depending on the type of harmonisation activity proposed, the ICH Steering Committee will endorse the establishment of either an Expert Working Group (EWG) or an Implementation Working Group (IWG).
Each of the six official ICH parties shall nominate official representatives to every EWG/IWG. Unless otherwise specified by the Steering Committee, the official membership of an EWG/IWG shall be limited to two officials per party per working group, one of who shall be designated as the Topic Leader and the other as the Deputy Topic Leader. ICH Observers may nominate one representative, as may Interested Parties, where applicable.
The Steering Committee officially designates a Rapporteur among the Topic Leaders designated by the six ICH parties, and in some cases a Co-Rapporteur may be appointed.