The ICH Step Process

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.

ICH STEP 1: DEVELOPMENT OF DRAFT CONSENSUS ICH GUIDELINE OR RECOMMENDATIONS

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.

ICH STEP 2: START OF REGULATORY ACTION

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.

ICH STEP 3: REGULATORY CONSULTATION

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.

ICH STEP 4: ADOPTION OF TRIPARTITE ICH GUIDELINE OR RECOMMENDATIONS

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.

ICH STEP 5: IMPLEMENTATION OF ICH GUIDELINE OR RECOMMENDATIONS

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.