The harmonization activities of ICH may fall into one of four categories: Formal ICH Procedure, Q & A Procedure, Revision Procedure, and Maintenance Procedure.
ICH Procedures
|
Type of
Procedure |
Deals with |
|
Formal ICH
Procedure |
New topic for
harmonization |
|
Q & A
Procedure |
Clarification
for an existing ICH Guideline |
|
Revision
Procedure |
Adding new
information to an existing ICH Guideline |
|
Maintenance
Procedure |
Changes to be
made to maintain a guideline |
First, a Concept Paper is prepared for the activity to be harmonized. This is a summary of the concept being proposed. Sometimes, a business plan may also be prepared to highlight the cost-benefit ratio of the harmonizing activity.
The formal ICH procedure then begins, in the following
steps:
Step 1: Building consensus: Based on the objectives
specified in the Concept Paper, a working group prepares a consensus draft
called the Technical Document. The working group’s technical experts sign off
on this, and the Step 1 Experts Technical Document is submitted to the ICH Assembly
with a request for adoption.
Step 2: (a) Based on the report: The assembly
confirms that the scientific consensus exists for the technical issues, and the
Technical Document may proceed further for regulatory consultation.
(b) This draft guideline is examined and endorsed by
regulatory members of the ICH Assembly.
Step 3: This happens in three different stages:
Consultation, discussion, and finalization of the Expert Draft Guideline by
regulatory members at different levels.
Stage 1: The draft guideline goes to the different
ICH regions for discussion in their respective regulatory regions.
Stage 2: All comments obtained during stage 1 are
addressed by the expert working group and after discussion, consensus is
reached to prepare the step 3 Experts Draft Guideline.
Stage 3: This draft guideline is finalized and signed
by the ICH regulatory member experts. The document is sent to ICH Assembly
regulatory members for further proceeding to step 4.
Step 4: ICH Assembly regulatory members agree that
sufficient scientific consensus exists on the draft guideline, and it gets
adopted as the ICH Harmonized Guideline.
Step 5: The ICH Harmonized Guideline is implemented
in all the ICH regions through their respective regulatory procedures.
Information about when it has become effective is sent to the ICH Assembly and
published on the ICH website.