Industry news

Revised ICH process

A revised process was agreed at the ICH meeting in Fukuoka, Japan on June 2-7, 2012. This revision was made at the insistence of the European Commission as a direct consequence of the Mediator affair in order to give the regulatory authorities more say in the selection of topics and the writing of guidelines. The changes are as follows:

1. The creation of a new role of “Regulatory Chair” within Expert Working Groups (EWG). Some of the duties of this Regulatory Chair will be to:

a. Liaise and report regularly to the Steering Committee,
b. Work with the Rapporteur on the EWG
c. Alert the Steering Committee if consensus seems not to be possible.
2. If six-party consensus on the need for a new ICH topic cannot be achieved, the three regulatory authority ICH parties can jointly decide to adopt a concept paper.

3. A new resolution process within Step 1 where consensus cannot be obtained.

4. After Step 2 approval has been obtained the Regulatory Chair will continue their role and work with the Rapporteur, who continues to one of the regulatory parties after Step 2.

This revised ICH process is due to be formally adopted at the next Steering Committee meeting in November 2012, although the appointment of the new Regulatory Chairs for guidelines that are at Step 1 will commence in September 2012.