The Formal ICH Procedure is a step-wise procedure consisting of 5 steps (see below, click to have information on a particular step). This procedure is followed for the harmonisation of all new ICH topics.

The procedure is initiated with the endorsement by the SC of a Concept Paper and Business Plan. An Expert Working Group (EWG) with membership as specified by the Concept Paper is subsequently established.

The EWG works to develop a draft Guideline and bring it through the various steps of the procedure which culminate in Step 5 and the implementation in the ICH regions of a Harmonised Tripartite Guideline.

 

Step 1: Consensus building

The EWG works to prepare a consensus draft of the Guideline, based on the objectives set out in the Concept Paper. Work is conducted via e-mail, teleconferences and web conferences.

If endorsed by the SC, the EWG will also meet face-to-face at the biannual SC meetings. Interim reports on the progress of the draft are made to the SC on a regular basis.

When consensus on the draft is reached among all six party EWG members, the EWG will sign the Step 2 Experts Signoff sheet. The Step 2 Experts Document with EWG signatures is then submitted to the Steering Committee to request adoption under Step 2 of the ICH process.

 

Step 2: Confirmation of six-party consensus

Step 2 is reached when the Steering Committee agrees, based on the report of the EWG, that there is sufficient scientific consensus on the technical issues for the draft Guideline to proceed to the next stage of regulatory consultation. This agreement is confirmed by at least one of the SC members for each of the six ICH parties signing their assent.

The consensus text approved by the Steering Committee is signed off by the Steering Committee as the Step 2 Final Document.

 

Step 3: Regulatory consultation and Discussion

Step 3 occurs in two distinct stages: regulatory consultation and discussion.

Stage I: Regional regulatory consultation: The Guideline embodying the scientific consensus leaves the ICH process and becomes the subject of normal wide-ranging regulatory consultation in the three regions. In the EU it is published as a draft CHMP Guideline, in Japan it is translated and issued by MHLW for internal and external consultation and in the USA it is published as draft guidance in the Federal Register.
Regulatory authorities and industry associations in non-ICH regions may also comment on the draft consultation documents by providing their comments to the ICH Secretariat.

Stage II: Discussion of regional consultation comments: After obtaining all comments from the consultation process, the EWG works to address the comments received and reach consensus on what is called the Step 4 Experts Document.

If the Rapporteur was from an industry party, following Step 2 a new Rapporteur from a regulatory party is appointed, preferably from the same region as the previous Rapporteur.

If both regulatory and industry parties of the EWG are satisfied that the consensus achieved at Step 2 is not substantially altered as a result of the consultation, or consensus is reached on any alterations, the Step 4 Experts Document is signed by the EWG regulatory experts.

The Step 4 Document with regulatory EWG signatures is submitted to the Steering Committee to request adoption as Step 4 of the ICH process.

 

Step 4: Adoption of an ICH Harmonised Tripartite Guideline

Step 4 is reached when the Step 4 Final Document is signed off by the SC signatories for the regulatory parties of ICH as an ICH Harmonised Tripartite Guideline at Step 4 of the ICH process.

 

Step 5: Implementation

Having reached Step 4 the harmonised tripartite Guideline moves immediately to the final step of the process that is the regulatory implementation. This step is carried out according to the same national/regional procedures that apply to other regional regulatory guidelines and requirements, in the European Union, Japan and the US.