1. Pink Sheet

ICH Seeks To Resolve Impasse Over Q12 Legal Review This Week

 
• By Bowman Cox

It remains uncertain whether a legal review by the European Commission that since June has delayed public consultation of draft ICH Q12 post-approval changes guideline can be resolved during this week's ICH meeting in Geneva.

At its meeting in Geneva, Switzerland, this week, the International Council for Harmonization will try to overcome concerns the European Commission raised in an 11th-hour legal review of the Q12 guideline on post-approval changes that ICH has been developing for the past three years.

At the previous ICH meeting, held the week of May 29 in Montreal, Canada, the council's management committee and assembly...

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