EMA: Regulatory information - EMA introduces weekly start dates for the assessment of type II variations from March 2015
The new timetables are expected to increase submission flexibility and streamline assessment of applications. From March 2015, the European Medicines Agency will introduce weekly start dates to facilitate the assessment of certain type II and worksharing variation applications for medicines for human use. These changes are one of the outcomes of the Agency’s structural reorganisation which was initiated in September 2013 to improve the efficiency and effectiveness of its operations. They are expected to offer more flexibility to applicants and streamline the assessment of applications by allowing certain variations to conclude outside of the plenary meeting of the Committee for Medicinal Products for Human Use (CHMP).