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 ICH Assembly of a Concept Paper and Business Plan. An Expert Working Group (EWG) 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 Guideline.


Step 1: Consensus building

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

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

When consensus on the draft is reached within the EWG, the technical experts of the EWG will sign the Step 1 Experts sign-off sheet. The Step 1 Experts Technical Document with EWG signatures is then submitted to the Assembly to request adoption under Step 2 of the ICH process.


Step 2a: Confirmation of consensus on the Technical Document

Step 2a is reached when the Assembly agrees, based on the report of the EWG, that there is sufficient scientific consensus on the technical issues for the Technical Document to proceed to the next stage of regulatory consultation.


Step 2b: Adoption of draft Guideline by Regulatory Members

On the basis of the Technical Document, the ICH Regulatory Members will take the actions they deem necessary to develop the draft Guideline.

Step 2b is reached when the Regulatory Members endorse the draft Guideline.


Step 3: Regulatory consultation and Discussion

Step 3 occurs in three distinct stages: regulatory consultation, discussion and finalisation of the Step 3 Expert Draft Guideline.

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 ICH regions. Regulatory authorities and industry associations in other 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 3 Experts Draft Guideline.

Stage III - Finalisation of Step 3 Experts Draft Guideline: If, after due consideration of the consultation results by the EWG, consensus is reached amongst the experts on a revised version of the Step 2b draft Guideline, the Step 3 Expert Draft Guideline is signed by the experts of the ICH Regulatory Members. The Step 3 Expert Draft Guideline with regulatory EWG signatures is submitted to the Regulatory Members of the Assembly to request adoption as Step 4 of the ICH process.


Step 4: Adoption of an ICH Harmonised Guideline

Step 4 is reached when the Assembly agrees that there is sufficient consensus on the draft Guideline.

The Step 4 Final Document is adopted by the ICH Regulatory Members of the ICH Assembly as an ICH Harmonised Guideline at Step 4 of the ICH process.


Step 5: Implementation

Having reached Step 4, the harmonised 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 ICH regions.