The ICH Harmonisation Process
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The ICH Process for Harmonisation of Guidelines

On the basis of experience to date, the Steering Committee has outlined a step-wise ICH Process for monitoring the progress of the harmonisation work and identifying the action which is needed in order to reach a defined end point. The process is primarily applicable to the development of harmonised tripartite guidelines or other statements of position.

Selection of Topics

Topics are selected for harmonisation, by the ICH Steering Committee, on the basis of a Concept Paper which may be proposed by one of the parties to ICH or by the ICH Expert Working Groups. The concept paper identifies the principle objectives of the harmonisation initiative in terms of the perceived problem and anticipated outcome.

The ICH Process

STEP 1:
A six-party Expert Working Group (EWG) is appointed for the Topic and one of the Topic Leaders is designated as the Rapporteur. (See
ICH Steering Committee and Expert Working Groups for further details)

Preliminary discussions of the topic are held between EWG members and a first draft is prepared by the Rapporteur. This may be a draft guideline, policy statement, recommendation, or "points to consider" document. The draft is reviewed and revised by the experts and succesve drafts are prepared until consensus is reached on the scientific issues. The draft is then forwarded, by the Expert Working Group, to the Steering Committee.

STEP 2:
The draft is "signed off" by the six co-sponsors in the Steering Committee and is transmitted to the three regional regulatory agencies for formal consultation in the EU, Japan and the USA, in accordance with normal internal and/or external consultation procedures. This regulatory consultation may include organisations and associations outside the ICH process, as well as IFPMA, EFPIA, JPMA and PhRMA, and the observers WHO, EFTA and Canada. The comment period should normally be six months, except when there are special circumstances to take into account.

STEP 3:
A Regulatory Rapporteur is designated from the EU, MHW or FDA. Comments are collected by the regulatory agencies in the three regions and exchanged with the other regulatory bodies. The Regulatory Rapporteur, in consultation with the other regulatory experts, analyses the comments and amends the "Step 2" draft, if necessary.

When significant changes result from the consultation process, such that the original consensus is not maintained, one or more regulatory authorities may recirculate the amended parts of the draft.

In other cases, the Regulatory Rapporteur prepares a final draft and agrees this with the regulatory experts from the other parties. The final draft is referred to the ICH Expert Working Group and "signed off" by the experts designated by the regulatory parties before being referred to the ICH Steering Committee for adoption.

STEP 4:
The final draft is discussed within the Steering Committee and "signed off" by the three regulatory parties to ICH. It is then recommended for adoption to the three regulatory bodies.

STEP 5:
The process is complete when the full recommendations are incorporated into domestic regulations or other appropriate administrative measures, according to national/regional internal procedures.

Copyright© 1998 International Federation of Pharmaceutical Manufacturers Associations