Chemistry Reference
In-Depth Information
1.4.1.7 observers
Since the ICH was initiated, there have been official observers associated with the
process to act as a link with non-ICH countries and regions. Each of the observer
parties has a seat on the ICH Steering Committee. The observers to ICH include
• The World Health Organization (WHO)
• The European Free Trade Area (EFTA), represented at ICH by Switzerland
• Canada, represented at ICH by the Drugs Directorate, Health Canada
1.4.2 Ich A
dmInIStrAtIon
ICH is administered by the ICH Steering Committee that is supported by the ICH
Secretariat. Since ICH was established, each of the six co-sponsors has had two seats
on the ICH Steering Committee, which oversees the harmonization activities. The
International Federation of Pharmaceutical Manufacturers Association (IFPMA) is
a federation of member associations representing the research-based pharmaceuti-
cal industry and other manufacturers of prescription medicines in fifty-six countries
throughout the world. IFPMA has been closely associated with ICH since its incep-
tion to ensure contact with the research-based industry outside the ICH Regions.
IFPMA has two seats on the ICH Steering Committee and runs the ICH Secretariat.
The Secretariat also participates as a nonvoting member of the Steering Committee.
The Secretariat operates from the IFPMA offices, in Geneva, and is primarily
concerned with preparations for, and documentation of, meetings of the Steering
Committee. The secretariat is also responsible for the coordination of preparations
for EWG meetings. The World Health Organization, the Canadian Health Protection
Branch, and the European Free Trade Association (EFTA) also nominate partici-
pants to attend the ICH Steering Committee meetings. In addition, each of the six
co-sponsors has designated an ICH Coordinator to act as the main contact point with
the ICH Secretariat. The ICH Coordinator ensures that ICH documents are distrib-
uted to the appropriate persons within the area of their responsibility.
1.4.3 Ich h
ArmonIzAtIon
P
roceSS
Topics are selected for harmonization by the ICH Steering Committee on the basis
of a concept paper proposed by one of the ICH parties or by the ICH Expert Working
Groups. The concept paper identifies the main objective of the proposed harmoniza-
tion in terms of the perceived problem and desired outcome.
Once initiated, the topic proceeds through a stepwise process, where, if com-
pleted, a final draft guideline is created and sent back to the member regulatory
agencies for implementation. The stepwise process proceeds as follows.
1.4.3.1 step 1
In the beginning, a six-party Expert Working Group (EWG) is appointed for the topic,
and one of them is chosen as the rapporteur. The EWG holds preliminary discussions
on the topic, and the rapporteur prepares a first draft. This draft may be a guideline,
policy statement, recommendation, or a “points to consider” document. The draft is
