ICHQ12 Step 2b

Q12 was one of the main topics on the agenda of the ICH management committee (MC) and the ICH assembly meetings in the regular ICH meeting that took place last November. The ICH MC, despite opposition from the industry, decided to recommend to the assembly to add the following language to the ICH Q12 core guideline text in chapter 1.1: “In certain ICH regions, the current ICH Q12 guideline is not fully compatible with the established legal framework with regard to the use of explicit Established Conditions (‘EC’) referred to in Chapter 3 and with the Product Lifecycle Management (‘PLCM’) referred to in Chapter 5 as outlined in this guideline. These concepts will, however, be considered when the legal frameworks will be reviewed and, in the interim, to the extent possible under the existing regulation in these ICH regions.” The assembly followed the recommendation from the ICH MC and decided to carry the guideline to Step 2b and this will be published soon most likely for an extended commenting period of 12 months.