A new topic for harmonisation may be proposed for the ICH process by an ICH party or an ICH observer who has to describe the proposal in a concept paper for submission to the ICH SC.
THE ICH STEP PROCESS
A
new topic for harmonisation may be proposed for the ICH process by an ICH party
or an ICH observer who has to describe the proposal in a concept paper for
submission to the ICH SC. The ICH SC decides upon the acceptance of the
proposal as ICH topic and the composition of the ICH Expert Working Group (ICH
EWG). An ICH EWG consists of experts from all Six Parties (usually two per
party) and, if an extension is considered appropriate, of additional experts
from interested parties beyond the Six Parties and the ICH observers. One
expert from each of the ICH observers may be nominated for any ICH EWG. Each of
the Six Parties nominates one of their experts as ICH Topic Leader who then
acts as contact point for the party he belongs to during the ICH process. The
ICH SC will ask one of the Six Parties to nominate the ICH Rapporteur who is
responsible for the drafting process. The development of an ICH guideline or of
ICH recommendations is a process of five steps.
The
ICH EWG develops the draft consensus ICH guideline or recommendations, usually
over a time not longer than 2 years. During this consensus building from a
scientific point of view, the ICH Topic Lead-ers consult the proposals within
the so-called ‘Contact Network’ of experts each party has established within
their regions and organisations, to ensure that they reflect the policies and
views of their party. Once consensus is reached between the Six Parties, the
ICH EWG performs a sign off of the draft ICH guide-line or recommendations
provided by the Rapporteur with the status of ICH Step 1 for transmission to
the ICH SC.
The
ICH SC discusses if there is sufficient scientific consensus to agree with the
draft ICH guideline or recommendations for transmission to the authorities in
each of the three ICH regions. If they agree, then each ICH party performs a
sign off at the level of the ICH SC, assigning the status of ICH Step 2 to the
draft ICH guideline or recommendations.
The
draft ICH guideline or recommendations are then presented to the authorities in
each of the three ICH regions for release for public consultation accord-ing to
the rules established in each region for public consultation of guidance
documents. Within each ICH region, comments are collected from all interested
parties and discussed by the Contact Network. The draft ICH guideline or
recommendations are also published by the ICH Secretariat for comments from authorities,
industry associations and interested parties outside the ICH regions to be
submitted to WHO or IFPMA. Out of the three ICH Topic Leaders from the
authorities, an ICH Regulatory Rapporteur is desig-nated to draw up the final
draft ICH guideline or recommendations, taking into account all comments
received during the consultation, as considered rele-vant by the respective
Contact Network. The final draft ICH guideline or recommendations are signed
off by the three ICH Topic Leaders from the authori-ties and transmitted to the
ICH SC.
The final draft ICH guideline or recommendations and a report on the comments received during the consul-tation are presented by the ICH Regulatory Rapporteur to the ICH SC for consideration as to whether the consensus achieved at ICH Step 2 has been substan-tially altered in the final draft. If not, the ICH SC adopts the ICH guideline or recommendations with a status of ICH Step 4 for recommendation for adoption by the authorities in the three ICH regions. If yes, the ICH SC considers the alterations in the final draft, and if all parties are satisfied, adopts it with the status of ICH Step 4. If one or more parties from industry are of the opinion that the draft has been substantially altered or introduces new issues, the parties from the authorities may agree to further consultation.
Immediately
after ICH Step 4, the ICH guideline or recommendations are processed for
adoption by the authorities and implementation in the three ICH regions
according to the rules established in each region for any guidance documents.
The
ICH step process is also followed for the main-tenance of existing ICH
guidelines resulting in major changes, whereas an abbreviated process has been
put in place for the maintenance requiring only minor changes.
Related Topics
TH 2019 - 2023 pharmacy180.com; Developed by Therithal info.