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 were ready to approve a draft Q12 technical document and...